Shoulder Arthroplasty and Arthrodesis

Number: 0837

Policy

  1. Aetna considers a Food and Drug Administration (FDA) approved total shoulder arthroplasty prosthesis medically necessary for adult members when the following criteria are met:
     
    1. Member has advanced joint disease demonstrated by:
         
      1. Pain and functional disability that interferes with activities of daily living (ADL) from advanced destructive joint disease associated with osteoarthritis, rheumatoid arthritis, avascular necrosis, or post-traumatic arthritis of the shoulder joint; and
      2. Limited range of motion and crepitus of the glenohumeral joint on physical examination: and
      3. Severe pain and loss of function of at least 6 months duration that interferes with ADL: and
      4. Radiographic evidence of destructive degenerative joint disease (as evidence by 2 or more of the following: irregular joint surfaces, glenoid sclerosis, osteophyte changes, flattened glenoid, cystic changes in the humeral head, or joint space narrowing) of shoulder joint); and
      5. History of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the medical record (see Note).  If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.  Note: Members should have at least 6 weeks of non-surgical treatment documented in the medical record, including all of the following, unless contraindicated:
         
        1. Anti-inflammatory medications or analgesics; and
        2. Flexibility and muscle strengthening exercises, and
        3. Activity modification; and
        4. Supervised physical therapy (ADLs diminished despite completing a plan of care); and
        5. Intra-articular injections of steroids into the shoulder (optional); and
        6. For rheumatoid arthritis only, anti-cytokine agents (e.g., etanercept, infliximab) and non-biologic DMARDs (e.g., azathioprine, cyclosporine, gold salts, hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine); or
           
    2. Treatment of proximal humeral fracture, malunion or nonunion confirmed by imaging with pain interfering with ADLs; or
    3. Malignancy of glenohumeral joint or surrounding soft tissue confirmed by imaging.
       
  2. Aetna considers total shoulder arthroplasty experimental and investigational in persons with glenohumeral osteoarthritis who have an irreparable rotator cuff tear.
     
  3. Aetna considers a reverse shoulder arthroplasty medically necessary for adult members with the following indications:
     
    1. Deficient rotator cuff with glenohumeral arthropathy and limited ability to actively flex the upper extremity to 90 degrees against gravity; or
    2. Failed hemiarthroplasty; or
    3. Failed total shoulder arthroplasty with failed rotator cuff that is non-repairable; or
    4. Massive rotator cuff tears with pseudo-paralysis and without osteoarthritis; or
    5. Reconstruction after a tumor resection; or
    6. Shoulder fractures that are not repairable or cannot be reconstructed with other techniques;

    and who meet all of the following criteria: 

    1. Pain and functional disability of at least 6 months duration that interferes with ADL (6 months not required for fractures or reconstruction for tumor resection); and
    2. Member should have limited functional demands; and
    3. History of of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the medical record (see Note).  If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.  Trial of conservative therapy is not required for fractures or reconstruction following tumor resection.  Note: Members should have at least 6 weeks of nonsurgical treatment documented in the medical record, including all of the following, unless contraindicated:
       
      1. Anti-inflammatory medications or analgesics; and
      2. Flexibility and muscle strengthening exercises, and
      3. Activity modification; and
      4. Supervised physical therapy (ADLs diminished despite completing a plan of care); and
      5. Intraarticular injections of steroids into the shoulder (optional); and
         
    4. Member's deltoid is intact; and
    5. Member’s joint must be anatomically and structurally suited to receive selected implants (i.e., adequate bone stock to allow for firm fixation of implant); and
    6. Member must have at least 90 degrees of passive shoulder range of motion (elevation/flexion); and
    7. Member does not have a condition that would place excessive stress on the implant (i.e., Charcot’ joint).
       
  4. Aetna considers a shoulder hemiarthroplasty medically necessary for adult members with the following indications:
     
    1. Rotator cuff tear arthropathy (severe rotator cuff tearing and end-stage arthritic disease); or
    2. Radiographic evidence of destructive degenerative joint disease from osteoarthritis or rheumatoid arthritis (as evidence by 2 or more of the following: irregular joint surfaces, glenoid sclerosis, osteophyte changes, flattened glenoid, cystic changes in the humeral head, or joint space narrowing) of shoulder joint); or
    3. Osteonecrosis without glenoid involvement; or
    4. Arthritic conditions in which the glenoid bone stock is inadequate to support a glenoid prosthesis; or
    5. Proximal humerus fracture not amenable to internal fixation;

    and who meet all of the following criteria:

    1. Pain and functional disability of at least 6 months duration that interferes with ADL (6 months not required for humeral fracture); and
    2. History of of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the medical record (see Note).  If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.  Trial of conservative therapy is not required for humeral fracture.  Note: Members should have at least 6 weeks of non-surgical treatment documented in the medical record, including all of the following, unless contraindicated:
       
      1. Anti-inflammatory medications or analgesics; and
      2. Flexibility and muscle strengthening exercises, and
      3. Activity modification; and
      4. Supervised physical therapy [Activities of daily living (ADLs) diminished despite completing a plan of care]; and
      5. Intra-articular injections of steroids into the shoulder (optional); and
         
    3. Member does not have a paralytic disorder of the shoulder.
       
  5. Aetna considers a revision or replacement of shoulder arthroplasty prosthesis medically necessary for the following indications when accompanied by pain and functional disability (interference with ADL):
     
    1. Aseptic loosening of 1 or more prosthetic components confirmed by imaging, or
    2. Fracture of one or more components of the prosthesis confirmed by imaging, or
    3. Confirmed peri-prosthetic infection by gram stain and culture, or
    4. Instability of the glenoid or humeral components; or
    5. Migration of the humeral head.
       
  6. Aetna considers total shoulder arthroplasty, hemiarthroplasty, reverse shoulder arthroplasty or arthroplasty revision or replacement not medically necessary in persons with any of the following absolute contraindications:
     
    1. Active infection of the joint or active systemic bacteremia that has not been totally eradicated; or
    2. Active skin infection (exception recurrent cutaneous staph infections) or open wound within the planned surgical site of the shoulder; or
    3. Rapidly progressive neurological disease; or
    4. Allergy to components of the implant (e.g., cobalt, chromium or alumina).
       
  7. For members with significant conditions or co-morbidities, the risk/benefit of total shoulder arthroplasty, hemiarthroplasty, reverse shoulder arthroplasty, or shoulder arthroplasty revision or replaceent should be appropriately addressed in the medical record.

  8. Aetna considers total shoulder arthroplasty, shoulder hemiarthroplasty, reverse shoulder arthroplasty, and shoulder arthroplasty revision or replacement experimental and investigational for all other indications. 

  9. Aetna considers shoulder arthrodesis medically necessary for the following indications:
     
    1. Active tuberculosis or bacterial infection of the joint; or
    2. Brachial plexus palsy with flail shoulder; or
    3. Recurrent shoulder dislocation; or
    4. Resection of tumor; or
    5. Irreparable rotator cuff tears; or
    6. Failed total shoulder arthroplasty; or
    7. Paralytic disorders of infancy.

    Where member has advanced disease demonstrated by:  

    1. Chronic, severe pain and functional disability that interferes with ADL; and
    2. Imaging evidence confirming the diagnosis; and
    3. History of of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the medical record (see Note).  If conservative therapy is not appropriate, the medical record must clearly document why such approach is not.  Note: Members with should have at least 6 weeks of non-surgical treatment documented in the medical record, including all of the following, unless contraindicated or otherwise not appropriate:
       
      1. Anti-inflammatory medications or analgesics; and
      2. Activity modification; and
      3. Supervised physical therapy (ADLs diminished despite completing a plan of care); and
      4. Assistive device use, as appropriate.
         
  10. For members with significant conditions or co-morbidities, the risk/benefit of shoulder arthrodesis should be appropriately addressed in the medical record.

  11. Aetna considers microfracturing of the shoulder experimental and investigational because the effectiveness of this approach has not been established.

  12. Aetna considers the use of acellular dermal extracellular matrix for shoulder capsular reconstruction experimental and investigational because the effectiveness of this approach has not been established.

See also CPB 0661 - Joint Resurfacing.

Background

Shoulder arthroplasty (also known as shoulder replacement surgery) was first carried out in the United States in the 1950s for the treatment of severe glenohumeral joint fractures.  Over the years, shoulder arthroplasty has been employed for the treatment of many other painful conditions/diseases of the shoulder (e.g., various forms of arthritis).  According to the Agency for Healthcare Research and Quality, approximately 53,000 people in the United States undergo shoulder arthroplasty each year.  This compares to more than 900,000 Americans a year who have knee and hip arthroplasty.  Shoulder arthroplasty should be considered if non-surgical treatments like medications as well as changes in activity are no longer helpful in relieving pain (American Academy of Orthopaedic Surgeons [AAOS], 2011). 

Farmer et al (2007) stated that although outcomes of shoulder, hip, and knee arthroplasties have been well-described, there have been no studies directly comparing the outcomes of these procedures as treatments for osteoarthritis (OA).  These investigators compared the inpatient mortality, complications, length of stay, and total charges of patients who had shoulder arthroplasty for OA with those of patients who had hip and knee arthroplasties for OA.  A review of the Maryland Health Services Cost Review Commission discharge database identified 994 shoulder arthroplasties, 15,414 hip arthroplasties, and 34,471 knee arthroplasties performed for OA from 1994 to 2001.  There were no in-hospital deaths after shoulder arthroplasty, whereas 27 (0.18 %) and 54 (0.16 %) deaths occurred after hip and knee arthroplasties, respectively.  Compared with patients who had hip or knee arthroplasties, patients who had shoulder arthroplasties had, on average, a lower complication rate, a shorter length of stay, and fewer total charges.  The latter had 1/2 as many in-hospital complications, were 1/6 as likely to have a length of stay 6 days or greater, and were 1/10 as likely to be charged more than $15,000.  The authors believed shoulder arthroplasty is as safe as the more commonly performed major joint arthroplasties.

The American Academy of Orthopaedic Surgeons’ clinical practice guideline on “The treatment of glenohumeral joint osteoarthritis” (AAOS, 2009) provided the following recommendations:

  • The work group is unable to recommend for or against the use of injectable corticosteroids when treating patients with glenohumeral joint OA (Strength of the recommendation: Inconclusive)
  • The use of injectable viscosupplementation is an option when treating patients with glenohumeral joint OA (Strength of the recommendation: Weak)
  • The work group is unable to recommend for or against the use of arthroscopic treatments for patients with glenohumeral joint OA.  These treatments include debridement, capsular release, chondroplasty, microfracture, removal of loose bodies, and biologic and interpositional grafts, subacromial decompression, distal clavicle resection, acromioclavicular joint resection, biceps tenotomy or tenodesis, and labral repair or advancement (Strength of recommendation: Inconclusive)
  • The work group is unable to recommend for or against open debridement and/or non-prosthetic or biologic interposition arthroplasty in patients with glenohumeral joint OA.  These treatments include allograft, autograft, and biologic and inter-positional grafts (Strength of recommendation: Inconclusive)
  • Total shoulder arthroplasty (TSA) and hemiarthroplasty are options when treating patients with glenohumeral joint OA (Strength of recommendation: Weak)
  • The work group suggests TSA over hemiarthroplasty when treating patients with glenohumeral joint OA (Strength of Recommendation: Moderate)
  • In the absence of reliable evidence, it is the opinion of this work group that TSA not be performed in patients with glenohumeral OA who have an irreparable rotator-cuff tear (Strength of recommendation: Consensus)
  • The work group is unable to recommend for or against physical therapy following shoulder arthroplasty (Strength of recommendation: Inconclusive)

Izquierdo and colleagues (2010) noted that the AAOS’s clinical practice guideline was based on a systematic review of published studies on the treatment of glenohumeral OA in the adult patient population.  Of the 16 recommendations addressed, 9 were inconclusive.  Two were reached by consensus: physicians use peri-operative mechanical and/or chemical venous thromboembolism prophylaxis for shoulder arthroplasty patients and TSA should not be performed in patients with glenohumeral OA who have an irreparable rotator-cuff tear.  Four options were graded as weak: the use of injectable viscosupplementation; TSA and hemiarthroplasty as treatment; avoiding shoulder arthroplasty by surgeons who perform fewer than 2 shoulder arthroplasties per year (to reduce the risk of immediate post-operative complications); and the use of keeled or pegged all-polyethylene cemented glenoid components.  The single moderate-rated recommendation was for the use of TSA rather than hemiarthroplasty.  The authors stated that management of glenohumeral OA remains controversial; the scientific evidence on this topic can be significantly improved.

In a prospective, randomized, double-blind clinical trial, Litchfield et al (2011) compared cemented and uncemented humeral fixation in TSA for primary shoulder OA.  Patients with primary shoulder OA requiring replacement were screened for eligibility.  After providing informed consent, subjects received baseline clinical and radiologic assessments, computed tomography scans, and standardized TSA.  After glenoid component insertion, patients were randomized to either a cemented or uncemented humeral component.  The primary outcome was the WOOS (Western Ontario Arthritis of the Shoulder Index) score at 2 years.  Other outcomes included the Short Form 12 score, American Shoulder and Elbow Surgeons score, McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, operative time, complications, and revisions.  Patients were assessed by a blinded evaluator at 2 and 6 weeks and 3, 6, 12, 18, and 24 months post-operatively.  A total of 161 patients consented to be included and were randomized: 80 in the cemented group and 81 in the uncemented group.  There were no significant differences in demographics or baseline evaluations between groups, except for gender.  The 12-, 18-, and 24-month WOOS scores showed a significant difference in favor of the cemented group.  The cemented group also had better strength and forward flexion.  As expected, the operative time was significantly less for the uncemented group.  The authors concluded that these findings provided level I evidence that cemented fixation of the humeral component provides better quality of life, strength, and range of motion than uncemented fixation.

The American College of Occupational and Environmental Medicine’s occupational medicine practice guideline on “Evaluation and management of common health problems and functional recovery in workers” (ACOEM, 2011) provided the following recommendations:

  • Total shoulder arthroplasty for moderate-to-severe shoulder (glenohumeral and acromioclavicular joint) OA (B = Moderate evidence-base: At least 1 high-quality study or multiple lower-quality studies relevant to the topic and the working population)
  • Arthroplasty, most commonly hemiarthroplasty, for select patients with displaced proximal humeral fractures (I = Insufficient Evidence: Evidence is insufficient or irreconcilable)
  • Arthroplasty for osteonecrosis (I = Insufficient Evidence: Evidence is insufficient or irreconcilable)
  • Total shoulder arthroplasty is contraindicated in young patients

The AAOS (2011) stated that conditions that cause shoulder pain and disability, and lead patients to consider shoulder joint replacement surgery include:

  • Avascular necrosis (osteonecrosis)
  • Failed previous shoulder replacement surgery
  • Osteoarthritis
  • Post-traumatic arthritis
  • Rheumatoid arthritis
  • Rotator-cuff tear arthropathy
  • Severe fractures

Sanchez-Sotelo (2011) stated that shoulder arthroplasty has been the subject of marked advances over the last few years.  Modern implants provide a wide range of options, including resurfacing of the humeral head, anatomic hemiarthroplasty, TSA, reverse shoulder arthroplasty and trauma-specific implants for fractures and nonunions.  Most humeral components achieve successful long-term fixation without bone cement.  Cemented all-polyethylene glenoid components remain the standard for anatomic TSA.  The results of shoulder arthroplasty vary depending on the underlying diagnosis, the condition of the soft-tissues, and the type of re-construction.  Total shoulder arthroplasty seems to provide the best outcome for patients with OA and inflammatory arthropathy.

In a Cochrane review, Singh et al (2011) determined the benefits and harm of surgery for shoulder OA.  These investigators performed a systematic review of clinical trials of adults with shoulder OA, comparing surgical techniques (TSA, hemiarthroplasty, implant type and fixation) to placebo, sham surgery, non-surgical modalities, and no treatment.  They also reviewed trials that compared various surgical techniques, reporting patient-reported outcomes (pain, function, quality of life, etc.) or revision rates.  They calculated the risk ratio for categorical outcomes and mean differences for continuous outcomes with 95 % confidence interval (CI).  There were no controlled trials of surgery versus placebo or non-surgical interventions.  A total of 7 studies with 238 patients were included.  Two studies compared TSA to hemiarthroplasty (n = 88).  Significantly worse scores on the 0 to 100 American Shoulder and Elbow Surgeons scale (mean difference, -10.05 at 24 to 34 months; 95 % CI: -18.97 to -1.13; p = 0.03) and a non-significant trend toward higher revision rate in hemiarthroplasty compared to TSA (relative risk 6.18; 95 % CI: 0.77 to 49.52; p = 0.09) were noted.  With 1 study providing data (n = 41), no differences were noted between groups for pain scores (mean difference 7.8; 95 % CI: -5.33 to 20.93), quality of life on Medical Outcomes Study Short-Form 36 physical component summary (mean difference 0.80; 95 % CI: -6.63 to -8.23), and adverse events (relative risk 1.2; 95 % CI: 0.4 to 3.8).  The authors concluded that TSA was associated with better shoulder function, with no other demonstrable clinical benefits compared to hemiarthroplasty.  They stated that more studies are needed to compare clinical outcomes between them and comparing shoulder surgery to sham, placebo, and other non-surgical treatment options.

In a systematic review and meta-analysis, Carter and colleagues (2012) characterized the change in generic and shoulder-specific health-related quality-of-life (QOL) measures resulting from TSA.  These investigators identified published studies reporting pre-operative and post-operative health-related QOL outcomes for patients receiving TSA.  Health-related QOL measures were identified, and meta-analysis was used to calculate standardized mean differences (SMDs, reflective of the effect size) and 95 % CI for each scale.  A total of 20 studies (1,576 TSA) met the inclusion criteria.  Outcome measures were analyzed after an average post-operative follow-up duration of 3.7 +/- 2.2 years.  The Short Form-36 demonstrated significant improvement in physical component summary scores (SMD = 0.7, p < 0.001) but not in mental component summary scores (SMD = 0.2, p = 0.37).  Significant improvements were observed in the visual analog scale score for pain (SMD = -2.5, p < 0.001) and scores on 3 shoulder-specific measures: the Constant score (SMD = 2.7, p < 0.001), American Shoulder and Elbow Surgeons score (SMD = 2.9, p < 0.001), and Simple Shoulder Test (SMD = 2.3, p < 0.001).  The authors concluded that TSA leads to significant improvements in scores for function and pain.  Shoulder-specific measures of function consistently showed the greatest degree of improvement, with large effect sizes.  They noted that TSA also leads to significant improvements in overall physical well-being, with a moderate-to-large effect size.

Singh et al (2012) evaluated the frequency of, and risk factors for, peri-prosthetic fractures during and following TSA.  All adults treated with a primary TSA or humeral head replacement at the Mayo Clinic Medical Center from 1976 to 2008 were identified.  Peri-prosthetic fractures were validated by medical record review.  Univariate and multivariable-adjusted logistic regression analyses were used to assess the association of demographic factors (age, sex, and body mass index [BMI]), underlying diagnosis, implant fixation (cemented or uncemented), American Society of Anesthesiologists (ASA) class, and co-morbidity as assessed with the Deyo-Charlson index.  The cohort consisted of 2,207 patients treated with a total of 2,588 primary TSA and 1,349 patients treated with 1,431 humeral head replacements.  A total of 72 medical-record-confirmed peri-prosthetic fractures occurred in association with TSA.  These consisted of 47 intra-operative fractures (40 humeral fractures, 5 glenoid fractures, and 2 fractures for which the site was unclear) and 25 post-operative fractures (20 humeral fractures, 3 glenoid fractures, and 2 fractures for which the site was unclear).  There were 33 fractures associated with the humeral head replacements -- 15 were intra-operative (8 humeral fractures and 7 glenoid fractures), and 18 were post-operative (16 humeral fractures and 2 glenoid fractures).  In the multivariable regression analysis of TSA, female sex (odds ratio [OR], 4.19; 95 % [CI]: 1.82 to 9.62; p < 0.001; a 2.4 % rate for women versus 0.6 % for men) and the underlying diagnosis (p = 0.04; post-traumatic arthritis: OR, 2.55; 95 % CI: 0.92 to 7.12) were associated with a significantly higher risk of intra-operative humeral fracture in general, and female sex was associated with the risk of intra-operative humeral shaft fracture (OR, infinity; p < 0.001).  In combined analyses of all patients (treated with either TSA or humeral head replacement), a higher Deyo-Charlson index was significantly associated with an increased risk of post-operative peri-prosthetic humeral shaft fracture (OR, 1.27; 95 % CI: 1.11 to 1.45); p < 0.001), after adjusting for the type of surgery (TSA or humeral head replacement).  The authors concluded that overall risk of peri-prosthetic fractures after TSA or humeral head replacement was low.  Women had a significantly higher risk of intra-operative humeral shaft fracture.  The underlying diagnosis (especially post-traumatic arthritis) was significantly associated with the risk of intra-operative humeral fracture, and co-morbidity was significantly associated with the risk of post-operative humeral shaft fracture.

The Swedish Orthopedic Institute (2012) states that “In most cases, someone who requires total-shoulder replacement has some form of arthritis.  Arthritis can cause the person to suffer pain, stiffness and limited function.  Beyond limited or painful mobility, night-time pain is a primary symptom of shoulder problems.  While there are several types of arthritis, most shoulder-replacement patients have rheumatoid arthritis (chronic joint inflammation) or osteoarthritis (a degenerative joint disease)”.

An UpToDate review on “Glenohumeral osteoarthritis” (Anderson, 2012) states that “Repeat x-rays should be performed at 3 months to look for disease progression if the patient has lost significant range of motion and/or symptoms have been progressive despite the above measures.  Surgical consultation can be considered if symptoms fail to improve significantly with 2 injections, stretching exercises, and time (6 to 12 months).  The primary indication for surgery is pain that is unresponsive to medical management.  The established surgical treatment for shoulder osteoarthritis is prosthetic replacement, except in very young patients where an arthroscopic debridement and removal of osteophytes might be attempted to delay the need for prosthetic replacement.  The outcomes of this procedure, however, are unpredictable, and should be seen as a measure of last resort in patients otherwise unsuitable for replacement due to age or functional requirements …. Either hemiarthroplasty or total shoulder replacement (a more complicated and technically more difficult procedure) is performed, depending upon the condition of the glenoid.  Both are associated with a high degree of success in the appropriate patients (greater than 72 to 90 %).  Hemiarthroplasty results in less improvement in function compared with total shoulder arthroplasty, but does not differ with respect to benefit for pain, range of motion, quality of life or strength.  Arthritis of the glenoid is responsible for continued pain and the need for revision arthroplasty in some patients who undergo initial hemiarthroplasty”.

An UpToDate review on “Osteonecrosis (avascular necrosis of bone)” (Jones, 2012) recommends that in patients with stage 4 osteonecrosis of the humeral head, and those who have less severe radiographic disease but continued symptoms, TSA is the treatment of choice.

Duquin et al (2012) reported the results and complications of unconstrained shoulder arthroplasty, one of several methods for treatment of proximal humeral fracture nonunions.  From 1976 to 2007, a total of 67 patients underwent unconstrained shoulder arthroplasty for proximal humeral nonunion and were followed for more than 2 years.  There were 49 women and 18 men with a mean age of 64 years and a mean duration of follow-up of 9 years (range of 2 to 30 years).  The fracture type according to the Neer classification was 2-part in 36 patients, 3-part in 16, and 4-part in 15.  Hemiarthroplasty was performed in 54 patients and TSA was done in the remaining 13.  There were 33 excellent or satisfactory results according to the modified Neer rating.  Tuberosity healing about the prosthesis occurred in 35 shoulders.  The mean pain score improved from 8.3 pre-operatively to 4.1 at the time of follow-up (p < 0.001).  The average active shoulder elevation and external rotation improved from 46° and 26° to 104° and 50° (p < 0.001).  Shoulders with anatomic or nearly anatomic healing of the tuberosities had greater active elevation at the time of final follow-up (p = 0.02).  There were 14 complications in 12 patients, with 12 re-operations including 5 revisions.  Kaplan-Meier survivorship with revision as the end point was 97 % (95 % [CI]: 94.3 to 100) at 1 year and 9 3% (95 % CI: 88.0 to 99.2) at 5, 10, and 20 years.  The authors concluded that shoulder arthroplasty decreases pain and improves function in patients with a proximal humeral nonunion.  However, the overall results are satisfactory in less than half of the patients.

In a multi-center, retrospective study, Favard et al (2012) evaluated the rate of complications and the functional improvement with different types of shoulder arthroplasties after a minimum follow-up of 8 years.  A total of 198 shoulders including 85 primary OA of the shoulder, 76 rotator-cuff tear arthropathies, 19 avascular necrosis, and 18 RA were included in this study.  Arthroplasties included 104 anatomic TSA, 77 reverse arthroplasties and 17 hemiarthroplasties.  Ten patients had their arthroplasty revised, and 134 patients with TSA were able to be present at the final follow-up or provide information on their case.  Function was evaluated by the Constant-Murley score and loosening by standard radiographs.  In the group with primary OA of the shoulder, there were 8 complications (11 %) including 6 (8.3 %) requiring implant revision.  In the group of rotator-cuff arthropathies, there were 9 (14.7 %) complications including 4 (6.5 %) requiring implant revision.  In the group with RA, there was 1 complication, and no surgical revision was necessary.  There were no complications in the group with avascular necrosis.  Glenoid migration occurred in 28.5 % of anatomic TSA, and 3.4 % of reverse arthroplasties.  This difference was significant (p < 0.001).  The Constant-Murley score was significantly improved in all etiologies.  The authors concluded that glenohumeral arthropathies can be successfully treated by arthroplasty.  Anatomic TSA was shown to be associated with a high-risk of glenoid loosening at radiographic follow-up, which makes us hesitate to use the cemented polyethylene implant, especially in young patients.

In a prospective, longitudinal study, Razmjou et al (2013) compared clinical and radiologic outcomes of TSA using 3 different prosthetic designs
  1. the Neer II system,
  2. the Bigliani-Flatow (BF), and
  3. a stemless prosthesis, the Total Evolutive Shoulder System (TESS). 
Patients with advanced OA of the glenohumeral joint who underwent TSA were followed up for 2 years.  Four patient-oriented disability outcomes were used.  The clinical data collected before surgery and at follow-up assessments during a 2-year period included active range of motion (ROM) in 6 directions and strength.  Radiographic signs of glenoid and humeral component loosening were recorded.  The incidence of humeral head subluxation was documented.  A total of 74 patients completed the study.  There was a significant improvement in the 4 disability measures, ROM, and strength at 2 years in all 3 groups (p < 0.0001).  Active external rotation at 90° abduction was statistically significantly lower in the Neer II group (p = 0.001).  The incidence of lucent lines around the glenoid component was higher in the Neer II group (p = 0.0002).  No statistically significant relationship was seen between type of prosthesis and patient satisfaction (p > 0.05).  The authors concluded that the 3 types of TSA prostheses used in this study all provided significant improvement in pain and function and were associated with high patient satisfaction.  The Neer II was associated with less active external rotation and more lucent lines.

Fevang et al (2012) evaluated function, pain, and QOL after shoulder arthroplasty in 4 diagnostic groups.  Patients with shoulder arthroplasties registered in the Norwegian Arthroplasty Register from 1994 through 2008 were posted a questionnaire in 2010.  A total of 1,107 patients with rheumatoid arthritis (RA), OA, acute fracture (AF), or fracture sequela (FS) returned completed forms (65 % response rate).  The primary outcome measure was the Oxford shoulder score (OSS), which assesses symptoms and function experienced by the patient on a scale from 0 to 48.  A secondary outcome measure was the EQ-5D, which assesses QOL.  The patients completed a questionnaire concerning symptoms 1 month before surgery, and another concerning the month before they received the questionnaire.  Patients with RA and OA had the best results with a mean improvement in OSS of 16 units, as opposed to 11 for FS patients.  Both shoulder pain and function had improved substantially.  The change in OSS for patients with AF was negative (-11), but similar end results were obtained for AF patients as for RA and OA patients.  Quality of life had improved in patients with RA, OA, and FS.  Good results in terms of pain relief and improved level of function were obtained after shoulder arthroplasty for patients with RA, OA, and-to a lesser degree-FS.  A shoulder arthropathy had a major effect on QOL, and treatment with shoulder replacement substantially improved it.

The American Academy of Orthopedic Surgeons’ clinical practice guideline on “The treatment of glenohumeral joint osteoarthritis” (AAOS, 2009) provided the following:  The work group is unable to recommend for or against open debridement and/or non-prosthetic or biologic interposition arthroplasty in patients with glenohumeral joint OA.  These treatments include allograft, autograft, and biologic and inter-positional grafts (Strength of recommendation: Inconclusive). 

Biological glenoid resurfacing with or without prosthetic humeral head replacement has been suggested as a means to avoid the potential complications of polyethylene use in younger patients with glenohumeral arthritis.  A variety of biologic surfaces, including anterior capsule, autogenous fascia lata, and Achilles tendon allograft, have been used; however, there is little evidence in the peer-reviewed literature that these biological grafts can provide a durable bearing surface over time.  Poor clinical outcomes related to persistent post-operative infection have also been reported (Elhassan et al, 2009).

The American Academy of Orthopedic Surgeons’ clinical practice guideline on “The treatment of glenohumeral joint osteoarthritis” (AAOS, 2009) provided the following:  The work group is unable to recommend for or against open debridement and/or non-prosthetic or biologic interposition arthroplasty in patients with glenohumeral joint OA.  These treatments include allograft, autograft, and biologic and inter-positional grafts (Strength of recommendation: Inconclusive). 

The 2012 textbook Canale & Beaty: Campbell's Operative Orthopaedics comments that, as it has become clear that glenoid arthritis continues to be a long-term concern for patients undergoing isolated shoulder hemiarthroplasty, some authors have explored various types of glenoid resurfacing procedures, particularly for younger, higher-demand patients.  These interposition techniques aim to allow the metal humeral head to articulate with a cushioning surface rather than with the native glenoid in an effort to minimize arthritic progression and subsequent pain.  A high number of failures and poor outcomes have been reported using Achilles tendon allograft as a resurfacing material with hemiarthroplasty.  Recently, lateral meniscal allografts have been used as an interposition material.  Although joint space narrowing did occur, glenoid erosion did not progress, suggesting that the lateral meniscus may offer some protection against glenoid wear.  While most interposition procedures have demonstrated early success, there are few long-term reports; therefore, further follow-up studies are necessary to better determine their ultimate outcomes.

According to the 2009 textbook DeLee: DeLee and Drez’s Orthopaedic Sports Medicine, biologic resurfacing of focal glenoid chondral lesions or glenoid arthritis is a viable alternative to total shoulder arthroplasty in the young patient.  Focal glenoid lesions that fail arthroscopic techniques can be “covered” with a soft tissue graft.  Hemiarthroplasty of the proximal humerus or a humeral resurfacing implant coupled with a biologically resurfaced glenoid alleviates many of the complications associated with glenoid component wear and loosening in young patients in short-term follow-up.

Elhassan et al (2009) reported that soft-tissue resurfacing of the glenoid, with arthroplasty of the humeral head, has been proposed as a viable treatment option for younger patients with symptomatic osteoarthritis of the shoulder.  The purpose of their study was to evaluate their results with soft-tissue resurfacing of the glenoid in patients with glenohumeral arthritis who were less than 50 years of age, as there was concern that this type of procedure was leading to poor outcomes.  Between 2000 and 2006, a total of 13 patients with an average age of 34 years underwent soft-tissue resurfacing of the glenoid and humeral head arthroplasty.  Achilles tendon allograft was used in 11 patients; fascia lata autograft in 1; and anterior shoulder joint capsule in 1.  Three patients had resurfacing of the humeral head with a stemless resurfacing implant, and 10 patients had a hemiarthroplasty.  The patients were followed for a minimum of 2 years or until failure, and the duration of follow-up averaged 48 months.  The results were graded with a visual analog pain scale, the subjective shoulder value, and the Constant and Murley score.  Radiographic review was performed in order to determine the degree of joint space loss and glenoid erosion.  Ten of the 13 patients required a revision total shoulder arthroplasty at a mean of 14 months (range of 6 to 34 months) post-operatively.  The principal reasons for revision were persistent pain and a decreased range of motion.  Radiographic evaluation at the time of the revision surgery demonstrated loss of joint space and glenoid erosion in all cases.  At the revision surgery, the allograft was found to be absent, and thick scar tissue, which may have been a graft remnant, was found at the perimeter of the glenoid.  Of the 3 patients who did not have a revision arthroplasty, 1 had good function, pain relief, and an improved range of motion; however, the post-operative course of the other 2 was complicated by infection.  One of them had a salvage with early irrigation and debridement as well as intravenous antibiotics, whereas the other underwent resection arthroplasty because of persistent infection.  The authors concluded, “soft-tissue resurfacing of the glenoid with an Achilles tendon allograft combined with humeral head arthroplasty is not a reliable method of treatment of glenohumeral arthritis in an active patient younger than 50 years of age, as the clinical outcome is poor.  Moreover, no evidence indicated that the graft acts as a durable bearing surface”.

Krishnan and colleagues (2007) published the 2- to 15-year outcomes of 34 patients (36 shoulders) who were managed with biologic glenoid resurfacing and humeral head replacement either with cement (10 shoulders) or without cement (26 shoulders).  The study group included 30 men and 4 women with an average age of 51years whose diagnoses included primary glenohumeral osteoarthritis (18 shoulders), post-reconstructive arthritis (12), post-traumatic arthritis (5), and osteonecrosis (1).  Anterior capsule was used for 7 shoulders, autogenous fascia lata for 11, and Achilles tendon allograft for 18.  The mean American Shoulder and Elbow Surgeons score was 39 points pre-operatively and 91 points at the time of the most recent follow-up.  According to Neer's criteria, the result was excellent for 18 shoulders, satisfactory for 13, and unsatisfactory for 5.  Glenoid erosion averaged 7.2 mm and appeared to stabilize at 5 years.  There were no revisions for humeral component loosening.  Complications included infection (2 patients), instability (3 patients), brachial plexitis (1 patient), and deep-vein thrombosis (1 patient).  Factors that appeared to be associated with unsatisfactory results were the use of capsular tissue as the resurfacing material and infection.

The American Academy of Orthopaedic Surgeons' clinical practice guideline on “The treatment of glenohumeral joint osteoarthritis” (2014) stated that “In the absence of reliable evidence, it is the opinion of this work group that total shoulder arthroplasty not be performed in patients with glenohumeral osteoarthritis who have an irreparable rotator cuff tear”.  (Strength of Recommendation: Consensus)

Reverse Shoulder Arthroplasty for the Treatment of Proximal Humeral Fractures

Gupta et al (2015) compared the outcomes of open reduction and internal fixation (ORIF), closed reduction and percutaneous pinning, hemi-arthroplasty (HA), and reverse shoulder arthroplasty (RSA) for proximal humerus fractures (PHFs). The search was performed on September 9, 2012 using an explicit search algorithm in the following databases: Medline, SportDiscus, CINAHL, and Cochrane Central Register of Controlled Trials.  Inclusion criteria were English language studies reporting clinical outcomes after surgical treatment of 3- or 4-part PHFs with a minimum of 1-year follow-up.   Levels 1 to 4 studies were eligible for inclusion.  Study methodological quality and bias was evaluated using the Modified Coleman Methodology Score.  Two-proportion Z test and multi-variate linear regression analyses were used for group comparisons.  Significantly better clinical outcomes were observed for ORIF over HA and RSA (American Shoulder and Elbow Score, Disabilities of Arm, Shoulder, and Hand, Constant) (p < 0.05).  However, ORIF had a significantly higher re-operation rate versus HA and RSA (p < 0.001 for both).  Comparing HA with RSA, there was no difference in any outcome measure.  The rate of tuberosity nonunion was 15.4 % in the HA group.  The authors concluded that there were more complications following closed reduction and percutaneous pinning versus ORIF, HA, and RSA (p < 0.05); ORIF for PHFs demonstrated better clinical outcome scores but with a significantly higher re-operation rate; HA and RSA were effective as well, but tuberosity nonunion remains a concern with HA.

Dezfuli et al (2016) noted that reverse total shoulder arthroplasty (RTSA) has been shown to be an effective treatment for PHF. These investigators evaluated outcomes of all patients with PHFs treated with RTSA as a primary procedure for acute PHF, a delayed primary procedure for symptomatic PHF malunion or nonunion, a revision procedure for failed PHF HA, or a revision procedure for failed ORIF.  Patients who underwent RTSA for PHF were evaluated for active ROM and Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test-12, American Shoulder and Elbow Surgeons (ASES), University of California-Los Angeles (UCLA) shoulder rating scale, Constant, and 12-Item Short Form Health Survey scores.  Scaption and external rotation (ER) strength were also assessed.  Reverse total shoulder arthroplasty was performed in 49 patients with PHF; 13 patients underwent RTSA for acute PHF, 13 for malunion or nonunion, 12 for failed PHF HA, and 11 for failed PHF ORIF; ER ROM, SPADI, ASES, UCLA, and Constant scores achieved significance.  The acute fracture group significantly out-performed the failed HA group in SPADI, ASES, and UCLA scores.  The malunion/nonunion group significantly out-performed the failed HA group in ASES and UCLA scores.  The acute fracture and malunion/nonunion groups each had significantly greater ER than the failed HA group.  The authors concluded that RTSA is an effective treatment option for PHF as both a primary and a revision procedure.  Primary RTSA out-performed RTSA done as a revision procedure; RTSA for acute PHF is comparable to RTSA for malunions and nonunions.  These outcomes of revision RTSA for failed HA and ORIF are more promising than previously published.

Chalmers and Keener (2016) stated that since its introduction in the United States in 2003, RTSA has been used with increasingly frequency as surgeons have observed the remarkable improvement in pain, ROM, and function associated with this implant. Reverse total shoulder arthroplasty was initially used exclusively for elderly, low-demand individuals with end-stage rotator cuff tear arthropathy.  However, RTSA is now being increasingly successfully employed for the management of irreparable rotator cuff tears, glenohumeral OA with an intact rotator cuff, acute PHFs, the sequelae of PHFs, neoplasms of the proximal humerus, inflammatory arthropathy, young patients as well as failed anatomic TSA and HA.  The authors concluded that while long-term outcomes are pending, short- and mid-term follow-up results suggested that in experienced hands, RTSA may be a reasonable treatment for many previously difficult to treat pathologies within the shoulder.

Shannon et al (2016) evaluated the outcomes of patients with failed osteosynthesis who undergo salvage RTSA compared with patients undergoing primary RTSA for PHFs. These investigators retrospectively reviewed 18 patients who underwent primary RTSA for acute PHFs and 26 patients who underwent arthroplasty after failed ORIF between 2003 and 2013.  Minimum follow-up was 2 years, with a mean follow-up of 3 years (range of 2.0 to 6.0).  There are no statistically significant differences in clinical outcomes between the 2 cohorts in the ASES scores and in the most recent forward flexion or external rotation.  The salvage RTSA cohort experienced a higher complication rate (8 %), including dislocation and aseptic loosening.  The primary RTSA cohort had a 5 % complication rate, with 1 late prosthetic joint infection requiring re-operation.  The authors concluded that although RTSA after failed ORIF has a higher rate of complications compared with acute RTSA, the revision and re-operation rate as well as clinical outcomes and shoulder function remained comparable.  They noted that when a surgeon approaches these complex fractures in patients with poor underlying bone stock, the findings of this study supported acute arthroplasty or ORIF with the knowledge that salvage RTSA still has the potential to achieve good outcomes if osteosynthesis fails.

Reverse Shoulder Arthroplasty for Massive Rotator Cuff Tears

Lin and colleagues (2016). Stated that RTSA, which reverses the ball and socket of the shoulder joint, was designed as a solution for pseudo-paralysis and rotator cuff arthropathy (RCA).

Patzer and associates (2016) stated that therapeutic options for the treatment of irreparable rotator cuff tears are fluent, dependent on the patients' claims and demands and on the grade of the ongoing RCA.  A partial rotator cuff reconstruction with sufficient tenolysis combined with interval slide techniques to restore the anterior and posterior force couple may be indicated if there is no fatty degeneration greater than grade-III of the rotator cuff muscles in a well-centered joint.  The margin convergence technique with side-by-side adaptation of the tendon limbs may reduce the load on the reconstructed tendons.  The role of the suprascapular nerve, which can probably be constricted by the retracted rotator cuff, and its therapy has not been completely clarified.  When distinct symptoms are present, neurolysis may be reasonable.  Tendon transfers can be indicated in a co-operative patient less than 65 years of age with a higher grade of muscular atrophy but without degenerative changes greater than grade-II according to Hamada with the loss of active external rotation (ER) but performable active flexion.  For postero-superior tears the latissimus dorsi or recently the teres major tendon transfer to the rotator cuff footprint may be appropriate.  For non-reconstructable antero-superior tears a partial transfer of the pectoralis major tendon is possible.  Careful subacromial arthroscopic debridement (AD) combined with biceps tenotomy (BT) and a cautious or reversed decompression may reduce the pain temporarily without having an influence on active motion until with the loss of active elevation the indication for a RSA is reached.

Garofalo and co-workers (2016) stated that rupture of the anterior and middle deltoid muscle associated with RCA could result in a definitive loss of shoulder function.  These investigators evaluated clinical outcomes after a concomitant RSA and deltoid repair under these circumstances.  Between 2006 and 2012, a total of 18 consecutive patients with a mean age of 69.7 years, affected by massive irreparable rotator cuff tear (MIRCT) and associated dehiscence or rupture of anterior and middle deltoid muscle underwent this operation through a modified antero-superior approach; 4 patients referred a previous shoulder surgery and deltoid tear was iatrogenic.  The other 14 cases had an attritional deltoid tears.  The average follow-up was 64 months (range of 25 to 121 months).  The mean active forward elevation (AFE) passed from a pre-operative mean of 53 ± 9.1 (range of 45 to 70) to 132.7 ± 11.6° (85 to 155°), active ER passed from a pre-operative mean value of 22.4 ± 3.6° (range of 18 to 26) to an average of 33.7 ± 4.7° (range of 30 to 40°).  Mean Constant score increased from 42 ± 6.1 (range of 31 to 51) pre-operatively to 72.3 ± 8.2 (range of 57 to 82) post-operatively.  At final review, deltoid contour subjectively was satisfactory to all patients with no palpable defects.  The authors concluded that RSA associated with a repair of deltoid tear could be a viable surgical option in cases of tear involving the anterior and middle deltoid associated with a RCA.

Virk and colleagues (2016) reviewed the current understanding of the role of RTSA for the management of irreparable rotator cuff tears without arthritis based on authors personal experience and available scientific literature.  Reverse total shoulder arthroplasty is a constrained arthroplasty system that can allow the deltoid and remaining rotator cuff to substitute for the lost function of irreparable rotator cuff.  Furthermore, the pain relief is consistent with often a dramatic improvement in patient comfort, shoulder function and stability.  In patients with pseudo-paralysis of the shoulder without advanced arthritis, RTSA effectively restored forward elevation above the shoulder but may not dramatically improve ER or internal rotation (IR).  However, due to concerns over implant longevity, caution has to be exercised when using RTSA for symptomatic irreparable rotator cuff tears with preserved AFE and in patients less than 65 years of age.  The authors concluded that RTSA is a reasonable surgical option for irreparable rotator cuff repair without arthritis.  However, caution should be exercised when offering RTSA to young patients and patient without pseudo-paralysis because they can have a higher complication and dissatisfaction rate.  In addition, longevity of RTSA and subsequent need for revision surgery remains a significant concern in this population.

Thorsness and Romeo (2016) stated that compared with smaller tears, massive rotator cuff tears (MRCT) present significant clinical management dilemmas for the treating surgeon because they are often fraught with structural failure and poor outcomes.  To optimize healing, current surgical methods look to optimize footprint coverage and enhance the biological environment for healing.  Double-row techniques have demonstrated clear biomechanical advantages in controlled cadaveric studies, but have yet to demonstrate clear clinical effectiveness over more simple repair techniques.  When repairs for MRCT fail, options include revision repair or superior capsular reconstruction, an option to bridge the tissue gap with human dermal allograft or fascia lata autograft in hopes of containing the humeral head from superior migration and precluding RCA.  The authors stated that although latissimus transfers remain a reasonable option for MRCT in appropriately indicated patients, clinical results are often unpredictable.  They noted that older patients with chronic, MRCT with pseudo-paralysis can achieve predictable, often excellent clinical results with a RTSA.

In a systematic review, Petrillo and colleagues (2017) reported the outcomes and complications of RSA in MIRCT and cuff tear arthropathy (CTA).  These investigators performed a systematic review of the literature contained in Medline, Cochrane, Embase, Google Scholar and Ovid databases on May 1, 2016, according to PRISMA guidelines.  The key words "reverse total shoulder arthroplasty" or "reverse total shoulder prostheses" with "rotator cuff tears"; "failed rotator cuff surgery"; "massive rotator cuff tears"; "irreparable rotator cuff tears"; "cuff tear arthropathy"; "outcomes"; "complications" were matched.  All articles reporting outcomes and complications of RSA for the management of MIRCT or CTA were included.  The comparison between pre-operative and post-operative clinical scores, as well as ROM, was performed using the Wilcoxon-Mann-Whitney test; p values lower than 0.05 were considered statistically significant.  A total of 7 articles were included in this qualitative synthesis.  A statistically significant improvement in all clinical scores and ROM was found comparing the pre-operative value with the post-operative value.  The degrees of retroversion of the humeral stem of the RSA did not influence the functional outcomes in a statistically significant fashion.  There were 17.4 % of complications.  The most frequent was heterotopic ossification, occurring in 6.6 % of patients.  Revision surgery was necessary in 7.3 % of patients.  The authors concluded that RSA restored pain-free ROM and improved function of the shoulder in patients with MIRCT or CTA.  However, complications occurred in a high percentage of patients.  They stated that the lack of level I studies limited the real understanding of the potentials and limitations of RSA for the management of MIRCT and CTA.

Sevivas and associates (2017) stated that MRCT are very large tears that are often associated with an uncertain prognosis.  Indeed, some MRCT even without OA are considered irreparable, and non-anatomic solutions are needed to improve the patient's symptoms.  Reverse shoulder arthroplasty is an option that can provide a more predictable pain relief and recovery of function.  However, outcomes after RSA for irreparable MRCT (MIRCT) have not been well defined.  In a systematic review with meta-analysis, these investigators reviewed the findings associated with the use of RSA in this subset of patients and analyzed the effect on patient functional status and pain.  These researchers carried out a comprehensive search until October 2015 using Medline, Scopus, Cochrane Database of Systematic Reviews, and Central Register of Controlled Trials databases.  Studies that assessed the outcomes of RSA in patients with MIRCT without OA (with at least 2 years of follow-up) were included.  If the results of MIRCT without OA were not possible to subgroup, the study was excluded.  Methodologic quality was assessed using the Coleman Methodology Score.  Included were 6 studies (266 shoulders) with a follow-up ranging from 24 to 61.4 months.  The mean Coleman Methodology Score was 58.2 ± 11.8 points.  There was an overall improvement from pre-operative to post-operative assessments of the clinical score (Cohen d = 1.35, p < .001), forward flexion (d = 0.50, p = 0.009), ER (d = 0.40, p < 0.001), function (d = 1.04, p < 0.001), and pain (d = -0.89, p < 0.001).  The authors concluded that patients with MIRCT without presence of OA have a high likelihood of achieving a painless shoulder and functional improvements after RSA.

Kang and co-workers (2017) noted that MIRCT cause significant shoulder pain and dysfunction.  Physical therapy (PT), AD-BT, and hemi-arthroplasty (HA) are treatments shown to reduce pain and improve QOL.  Reverse total shoulder arthroplasty is a newer surgical treatment option that may offer improved function.  A cost-effectiveness analysis of these interventions has never been performed, and no head-to-head comparative effectiveness trials currently exist.  In this study, a Markov decision analytic model was used to compare RTSA, HA, AD-BT, and PT as treatments for elderly patients with MIRCT.  Probabilities for complications, peri-operative death, conversion procedures, and re-operations were derived from the literature, and costs were determined by average Medicare reimbursement rates from 2011.  Reverse total shoulder arthroplasty yielded the most quality-adjusted life years (QALY) with 7.69, but greater benefits came at higher costs compared with other treatments.  Sensitivity analyses showed that PT was the most cost-effective intervention at a health utility of 0.75 or greater (QALY 7.35).  The health utility of RTSA was 0.72 or less (QALY 7.48) or RTSA probability of no complications was 0.83 or less (QALY 7.48 at cost of $23,830).  Reverse total shoulder arthroplasty yielded benefits at a cost considered good value for money compared with other treatments.  The authors concluded that RTSA is the preferred and most cost-effective therapeutic option for elderly patients with MIRCT.  For patients seeking pain relief without functional gains, AD-BT can be considered a cost-effective and cheaper alternative.

Microfracturing of the Shoulder

Frank et al (2010) stated that microfracture is an effective surgical treatment for isolated, full-thickness cartilage defects with current data focused on applications in the knee.  No studies describing clinical outcomes of patients who have undergone microfracture in the shoulder joint have been reported.  These researchers hypothesized that treatment of glenohumeral joint articular defects using microfracture would demonstrate similar short-term clinical outcomes when compared with other joints.  From March 2001 to August 2007, a total of 16 patients (17 shoulders) who underwent arthroscopic microfracture of the humeral head and/or glenoid surface were retrospectively reviewed.  All patients were examined by an independent, blinded examiner and completed surveys containing the Simple Shoulder Test (SST), American Shoulder and Elbow Score (ASES), and visual analog scale (VAS).  Two patients were lost to follow-up, for a follow-up rate of 88 %.  Three patients went on to subsequent shoulder surgery and were considered to have failed results.  The mean age was 37.0 years (range of 18 to 55 years) with an average follow-up of 27.8 months (range of 12.1 to 89.2 months).  The average size of humeral and glenoid defects was 5.07 cm(2) (range of 1.0 to 7.84 cm(2)) and 1.66 cm(2) (range of 0.4 to 3.75 cm(2)), respectively.  There was a statistically significant decrease from 5.6 +/- 1.7 to 1.9 +/- 1.4 (p < 0.01) in VAS after surgery as well as statistically significant improvements (p < 0.01) in SST (5.7 +/- 2.1 to 10.3 +/- 1.3) and ASES (44.3 +/- 15.3 to 86.3 +/- 10.5).  Twelve (92.3 %) patients claimed they would have the procedure again.  The authors concluded that microfracture of the glenohumeral joint provided a significant improvement in pain relief and shoulder function in patients with isolated, full-thickness chondral injuries.  Moreover, they stated that longer-term studies are needed to determine if similar results are maintained over time.

Gross et al (2012) conducted a systematic review of clinical outcomes after cartilage restorative and reparative procedures in the glenohumeral joint, to identify prognostic factors that predict clinical outcomes, to provide treatment recommendations based on the best available evidence, and to highlight literature gaps that require future research.  These investigators searched Medline (1948 to week 1 of February 2012) and Embase (1980 to week 5 of 2012) for studies evaluating the results of arthroscopic debridement, microfracture, osteochondral autograft or allograft transplants, and autologous chondrocyte implantation for glenohumeral chondral lesions.  Other inclusion criteria included minimum 8 months' follow-up.  The Oxford Level of Evidence Guidelines and Grading of Recommendations Assessment, Development and Evaluation (GRADE) recommendations were used to rate the quality of evidence and to make treatment recommendations.  A total of 12 articles met the inclusion criteria, which resulted in a total of 315 patients; 6 articles pertained to arthroscopic debridement (n = 249), 3 to microfracture (n = 47), 2 to osteochondral autograft transplantation (n = 15), and 1 to autologous chondrocyte implantation (n = 5).  Whereas most studies reported favorable results, sample heterogeneity and differences in the use of functional and radiographic outcomes precluded a meta-analysis.  Several positive and negative prognostic factors were identified.  All of the eligible studies were observational, retrospective case series without control groups; the quality of evidence available for the use of the aforementioned procedures is considered "very low" and "any estimate of effect is very uncertain".  The authors concluded that more research is needed to determine which treatment for chondral pathology in the shoulder provides the best long-term outcomes.  They encouraged centers to establish the necessary alliances to conduct blinded, randomized clinical trials and prospective, comparative cohort studies necessary to rigorously determine which treatments result in the most optimal outcomes.  At this time, high-quality evidence is lacking to make strong recommendations, and decision-making in this patient population is performed on a case-by-case basis.

Milano and colleagues (2013) evaluated the effectiveness of a marrow-stimulating technique with microfractures of the greater tuberosity during arthroscopic rotator cuff repair.  A total of 80 patients with a full-thickness rotator cuff tear underwent an arthroscopic single-row repair.  Patients were divided into 2 groups of 40 cases each.  In group 1, standard repair was performed; in group 2, microfractures of the greater tuberosity were performed to enhance tendon repair.  Clinical outcome was assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) score and normalized Constant score.  Tendon integrity was assessed with magnetic resonance imaging.  Multivariate analysis was performed to determine which predictors were independently associated with the outcome.  Significance was set at p < 0.05.  The mean follow-up was 28.1 ± 3 months; 7 patients were lost to follow-up (2 in group 1 and 5 in group 2).  Comparison between groups did not show significant differences for baseline characteristics.  The mean DASH score was 28.6 ± 21.3 points in group 1 and 23.3 ± 20.1 points in group 2.  Although the difference was not statistically significant, the CI included a 10-point value (minimal clinically important difference) in favor of the microfracture group.  The difference in the Constant score between groups was not significant.  The tendon healing rate was 52.6 % in group 1 and 65.7 % in group 2, without a significant difference between groups.  Subgroup analysis for tear size showed that group 2 had a significantly greater healing rate than group 1 for large tears (p = 0.040).  Multivariate analysis showed that age, timing of symptoms, tear location, tendon retraction, and fatty infiltration significantly affected the outcomes.  The authors concluded that post-operative magnetic resonance imaging did not show any significant difference between groups in structural integrity.  However, subgroup analysis showed a significantly greater healing rate in the microfracture group for large tears involving the supraspinatus and infraspinatus.

The American Academy of Orthopaedic Surgeons (AAOS)’s clinical practice guideline on “The treatment of glenohumeral joint osteoarthritis” (2014) stated that “The work group is unable to recommend for or against the use of arthroscopic treatments for patients with glenohumeral joint osteoarthritis. These treatments include debridement, capsular release, chondroplasty, microfracture, removal of loose bodies, and biologic and interpositional grafts, subacromial decompression, distal clavicle resection, acromioclavicular joint resection, biceps tenotomy or tenodesis, and labral repair or advancement”.

Hunnebeck and colleagues (2017) noted that an increasing number of young patients are diagnosed with chondral lesions.  Minimally invasive surgical techniques are important in order to delay progression of the early stages of OA and the need for total joint replacement.  In this study, patients (n = 32) who had received microfracturing of the shoulder were retrospectively enrolled, of whom 5 had received shoulder replacements after a mean time of 47 months.  Of these patients, 23 completed the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley Scores in addition to an additional subjective questionnaire.  Patients were then clinically examined and received X-ray analysis of the operated shoulder.  Data from an additional 4 patients were acquired by telephone interview.  Mean follow-up was 105 months.  Of the included patients, 13/27 patients reported no pain, 12/27 patients moderate pain.  Of these 12, 6/27 reported pain only at night and 3/27 only during rest.  Concerning the outcome of surgery, 19/27 patients were "satisfied" or "very satisfied".  There was a statistically significant increase in internal rotation, but no further differences in the ROM pre- and post-operatively.  Patients without any signs of OA before surgery showed statistically significantly better outcomes.  There was a statistically significant increase in radiological signs of OA in pre- versus post-operative patients.  Patients with bipolar lesions showed statistically significantly poorer subjective shoulder value (SSV) results.  The authors concluded that although microfracturing did not prevent radiographic progression, microfracture of the glenohumeral joint might be worth considering as part of a treatment regimen for younger patients who may not yet be treated with arthroplasty.

Frehner and Benthien (2017) provided a literature review from 2010 to 2014 concerning the quality of evidence in clinical trials regarding microfracture in attempt to repair articular cartilage.  These investigators focused on microfracturing, since this appeared to be the best documented technique.  Interest in evaluation of publication quality has risen in orthopedic sports medicine recently.  Thus, these researchers thought it was necessary to evaluate recent clinical trials being rated for their evidence-based medicine (EBM) quality.  They also compared the mean impact factor of the journals publishing the different studies as an indicator of the study's citation and evaluated for a change over the studied time frame.  To measure the EBM level, these investigators applied the modified Coleman Methodology Score (CMS) introduced by Jakobsen.  The impact factor, which is a measurement of the yearly average number of citations of articles recently published in that journal, was evaluated according to self-reported values on the corresponding journal's website.  They found that the mean CMS has not changed between 2010 and 2014.  The mean impact factor has also not changed between 2010 and 2014.  The CMS variance was high, pointing to different qualities in the evaluated studies.  There was no evidence that microfracturing was superior compared to other cartilage repair procedures.  The authors concluded that microfracture could not be seen as an evidence-based procedure.  Moreover, they stated that further research is needed and a standardization of the operating method is desirable. Furthermore, there is a need for more substantial studies on microfracturing alone without additional therapies.

In a case-series study, Wang and associates (2018) presented long-term clinical outcomes of patients undergoing microfracture of full-thickness articular cartilage defects of the glenohumeral joint.  A total of 16 consecutive patients (17 shoulders) were retrospectively reviewed who underwent arthroscopic microfracture of the humeral head and/or glenoid surface, with or without additional procedures between 2001 and 2008 and with a minimum follow-up of 8.5 years.  All patients completed pre- and post-operative surveys containing the visual analog scale (VAS), American Shoulder and Elbow Surgeons form, and Simple Shoulder Test.  Complications and re-operations were analyzed.  Failure was defined by biological resurfacing or conversion to arthroplasty.  Of the original 16 patients (17 shoulders), 13 patients (14 shoulders) were available for mean follow-up at 10.2 ± 1.8 years after microfracture (range of 8.5 to 15.8 years), for an overall clinical follow-up rate of 82 %.  The patients (6 men, 7 women) were 36.1 ± 12.9 years old at time of microfracture.  The average size of humeral head defects was 5.20 cm2 (range of 4.0 to 7.84 cm2), and the average size of glenoid defects was 1.53 cm2 (range of 1.0 to 3.75 cm2); 4 patients (4 shoulders) underwent at least 1 re-operation, and 3 were considered to have structural failures.  The average time to failure was 3.7 years after microfracture (range of 0.2 to 9.6 years).  The overall survival rate was 76.6 % at 9.6 years.  For these patients, there were statistically significant improvements in VAS, Simple Shoulder Test, and American Shoulder and Elbow Surgeons scores as compared with pre-operative values at long-term follow-up (p < 0.05 for all), without any significant change from short-term (mean of 2.3 years) to long-term (mean of 10.2 years) follow-up.  There was no significant difference in Single Assessment Numeric Evaluation or Short Form-12 Physical or Mental scores between short- and long-term follow-up.  When compared with short-term follow-up, in which 2 patients had already failed, 1 additional patient progressed to failure at 9.6 years after the original microfracture; 2 patients (2 shoulders) were considered to have clinical failure.  Owing to the overall number of failures (3 structural failure and 2 clinical failure), the total long-term success rate of glenohumeral microfracture is 66.7 % in the current study.  The authors concluded that treating full-thickness symptomatic chondral defects of the glenohumeral joint with microfracture could result in long-term improved function and reduced pain for some patients.  However, in this study, 21.4 % of patients needed conversion to arthroplasty less than 10 years after the index microfracture procedure, and 33 % to 42 % of patients were considered to have potential clinical failure.  These investigators stated that additional studies with larger patient cohorts are needed.  Level of Evidence = IV.

Furthermore, an UpToDate review on “Management of rotator cuff tears” (Marin and Martin, 2018) does not mention microfracture as a therapeutic option.

Use of Acellular Dermal Extracellular Matrix for Shoulder Capsular Reconstruction

Ely et al (2014) stated that despite advances in surgical techniques, 20 % to 90 % of rotator cuff (RC) repairs fail.  They tend to fail at the suture-tendon junction due to tension at the repair and gap formation prior to healing.  This study evaluated the gap formation and ultimate tensile failure loads of a RTC repair with a de-cellularized human dermal allograft.  Augmentation of a RTC repair with an extracellular matrix graft decreased gap formation and increased load to failure in a human RC repair model.

Lee et al (2014) noted that acromio-clavicular (AC) separations are one of the most common shoulder injuries that may lead to pain, disability, and dysfunction of the shoulder girdle.  Over 100 different surgical procedures have been described in the literature for the treatment of this injury.  Initial surgical repairs were non-anatomic and non-biological.  In recent years, allograft reconstruction has become accepted for the treatment of chronic separations, but most reconstructions are aimed at restoring the coraco-clavicular ligaments.  Very little attention has been placed on the reconstruction of the AC joint itself.  The technique described is an anatomic, biological reconstruction of the coraco-clavicular ligaments to restore stability in the vertical plane, and of the AC joint to restore stability in the horizontal plane.

Mirzayan et al (2015) stated that rupture of the distal bicep brachii tendon has received significant attention as a result of increased awareness of injury, numerous surgical fixation techniques, and debate regarding single versus dual incision surgery.  The majority of ruptures may be fixed primarily.  On rare occasion, the tendon may be attritionally thinned, or may not have the elasticity to be directly repaired back to the radial tuberosity.  These investigators described a technique for using acellular dermal allograft to augment (not bridge) attritional distal biceps ruptures.

Gilot et al (2014) stated that despite advances in surgical technology, as well as generally good outcomes, repairs of full-thickness RC tears (RCTs) showed a re-tear rate of 25 % to 57 % and may fail to provide full return of function.  The repairs tend to fail at the suture-tendon junction, which is due to several factors, including tension at the repair site, quality of the tendon, and defective tissue repair.  One strategy to augment repair of large to massive RTC tears is the development of biological scaffold materials, composed of extra-cellular matrix (ECM).  The goal was to strengthen and evenly distribute the mechanical load across the repair site, thus minimizing the rupture risk of the native tendon while providing the biological elements needed for healing.  The promising results of ECM-derived materials and their commercial availability have increased their popularity among shoulder surgeons.  In contrast to a traditional open or arthroscopically assisted mini-open approach, this completely arthroscopic technique offered the full advantages warranted by the use of a minimally invasive approach.  This technical guide described arthroscopic RTC repair using an ECM graft technique.

Gilot et al (2015) compared the results of arthroscopic repair of large to massive RCTs with or without augmentation using an ECM graft and presented ECM graft augmentation as a valuable surgical alternative used for biomechanical reinforcement in any RCT repair.  These investigators performed a prospective, blinded, single-center, comparative study of patients who underwent arthroscopic repair of a large to massive RCT with or without augmentation with ECM graft.  The primary outcome was assessed by the presence or absence of a re-tear of the previously repaired RTC, as noted on ultrasound (US) examination.  The secondary outcomes were patient satisfaction evaluated pre-operatively and post-operatively using the 12-item Short Form Health Survey, the American Shoulder and Elbow Surgeons shoulder outcome score, a visual analog scale score, the Western Ontario Rotator Cuff index, and a shoulder activity level survey.  They enrolled 35 patients in the study: 20 in the ECM-augmented RC repair group and 15 in the control group.  The follow-up period ranged from 22 to 26 months, with a mean of 24.9 months.  There was a significant difference between the groups in terms of the incidence of re-tears: 26 % (4 re-tears) in the control group and 10 % (2 re-tears) in the ECM graft group (p = 0.0483).  The mean pain level decreased from 6.9 to 4.1 in the control group and from 6.8 to 0.9 in the ECM graft group (p = 0.024).  The American Shoulder and Elbow Surgeons score improved from 62.1 to 72.6 points in the control group and from 63.8 to 88.9 points (p = 0.02) in the treatment group.  The mean Short Form 12 scores improved in the 2 groups, with a statistically significant difference favoring graft augmentation (p = 0.031), and correspondingly, the Western Ontario Rotator Cuff index scores improved in both arms, favoring the treatment group (p = 0.0412).  The authors concluded that the use of ECM for augmentation of arthroscopic repairs of large to massive RCTs reduced the incidence of re-tears, improves patient outcome scores, and was a viable option during complicated cases in which a significant failure rate was anticipated.  Level of Evidence = III.  This was a small study (n = 20 in the ECM group) with shorter-term follow-up (mean of 24.9 months).

Levenda et al (2015) described an arthroscopic method specifically developed to augment RC repair using a flexible acellular dermal patch (ADP).  In this method, an apparently complex technique is simplified by utilizing specific steps to augment a RC repair.  In this method, using a revised arthroscopic technique, RC repair was performed.  This technique allowed easy passage of the graft, excellent visualization, minimal soft tissue trauma, and full four-corner fixation of an ADP.  A total of 12 patients underwent RC repair with augmentation using the combination of this method and ADP.  Due to the technique and biomechanical characteristics of the material, the repairs have been stable and with high patient satisfaction.  The authors concluded that these clinical results should be considered with the limitations of an informal case series.  Moreover, they stated that while further long-term study and the larger patient base are needed to have significance, these short-term (1-year) results demonstrated favorable outcomes especially in patients with an increased risk of failure.

Katthagen et al (2016) noted that the superior capsule reconstruction (SCR) is a novel therapeutic option for massive, irreparable postero-superior RCTs.  Treatment goals of such tears are to reduce pain, restore shoulder function and delay the development of advanced cuff tear arthropathy.  Current non-prosthetic treatment options include debridement and partial RC repair, bridging RC reconstruction with a graft and latissimus dorsi transfer, although each has different factors which limit their clinical application.  Superior capsule reconstruction is a promising alternative treatment for irreparable postero-superior RCT.  It utilized a graft from the superior glenoid to the greater tuberosity to stabilize the humeral head.  In a study by Mihata and colleagues of 23 patients who underwent SCR with a fascia lata autograft at a minimum of 2 years follow-up, the American Shoulder and Elbow Surgeons (ASES) score improved significantly from 23.5 pre-operatively to 92.9.  Post-operative MRI showed 83 % of patients had intact reconstructions with no progression of muscle atrophy.   The authors concluded that from their early results, pain relief has been dramatic and they believed the inter-position effect of the graft may also play a role in decreasing pain.  They stated that patient selection and long-term benefits need to be investigated in further clinical trials.

Petri et al (2016) evaluated minimum 2-year clinical outcomes after open revision biologic patch augmentation in patients with massive RC re-tears who had deficient RC tendons with healthy RC muscles.  Patients with massive postero-superior RC re-tears who underwent open revision RC repair with patch augmentation were identified from a surgical registry.  Outcomes data collected included American Shoulder and Elbow Surgeons; Quick Disabilities of the Arm, Shoulder and Hand; Single Assessment Numeric Evaluation; and Short Form-12 Physical Component Summary scores along with post-operative patient satisfaction, and activity modification.  There were 10 men and 2 women (13 shoulders, 1 bilateral) with a mean age of 57 years (range of 26 to 68 years).  All patients had at least 1 prior arthroscopic RC repair.  After patch augmentation, there were no complications, no adverse reactions to the patch, and no patients required further surgery; 1 patient (7.7 %) with 4 prior cuff repairs had a documented postero-superior re-tear on MRI 2 months after repair.  Minimum 2-year outcome scores were available for 12 of 13 (92.3 %) shoulders after a mean follow-up period of 2.5 years (range of 2.0 to 4.0 years).  The ASES score improved by 21.5 points.  Although the pain component of the ASES score and the total ASES score did not improve significantly, the function component of the ASES score improved significantly when compared with their pre-operative baselines (p < 0.05).  Median patient satisfaction at final follow-up was 9/10 (range of 2 to 10).  The authors concluded that biologic patch augmentation with human acellular dermal allograft was a safe and effective treatment method for patients with massive RC re-tears with deficient postero-superior RC tendons in the presence of healthy RC muscles.  Level of Evidence = IV.  This was a small study (n = 12) with short-term follow-up (mean of mean of 2.5 years).

Hirahara et al (2017) noted that SCR is performed to reduce the pain and disability caused by irreparable supraspinatus RCTs.  These investigators discussed 9 cases of irreparable RCT managed with arthroscopic SCR with dermal allograft.  At minimum 2-year follow-up (mean of 32.38 months), the patients were prospectively evaluated on the ASES shoulder index, a VAS for pain, acromial-humeral distance, and US.  Patients were compared before and after surgery and against historical controls who underwent repair of massive RCTs.  From before surgery to 2 years after surgery, mean ASES score improved significantly (p < 0.00002), from 43.54 to 86.46, and mean VAS pain score decreased significantly (p < 0.00002), from 6.25 to 0.38.  For the historical controls at final follow-up, mean ASES score was 70.71 (p = 0.11), and mean VAS pain score was 3.00 (p < 0.05).  Mean acromial-humeral distance improved from 4.50 mm before surgery to 8.48 mm immediately after surgery (p < 0.0008) and 7.60 mm 2 years after surgery (p < 0.05).  Ultrasonography revealed pulsatile vessels within the allograft tissue between 4 and 8 months after surgery; 1 patient underwent reverse total shoulder arthroplasty (RTSA) for anterior escape; another had the graft rupture after a motor vehicle accident.  The authors concluded that these findings showed SCR with dermal allograft effectively restored the superior restraints in the glenohumeral joint and yielded outstanding clinical outcomes even after 2 years, making it an excellent viable alternative to RTSA.  This was a small study (n = 9) with short-to mid-term follow-up (mean of mean of 32.38 months).

Hartzler and Burkhart (2017) stated that SCR of the shoulder has recently gained popularity as an option for joint-preserving shoulder surgery for patients with an irreparable RCT.  In the absence of glenohumeral arthritis, RCT irreparability should only be diagnosed for most patients after a careful diagnostic arthroscopy.  Superior capsular reconstruction adds biological, passive, superior constraint to the glenohumeral joint, thereby optimizing the RC force couples and improving joint kinematics.  At short-term follow-up, SCR has been shown to be effective for pain relief and restoration of active shoulder motion, even in the worst cases of shoulder dysfunction (true shoulder pseudo-paralysis).  The rapid early adoption and expansion of SCR is justified by its excellent anatomical, biomechanical, and short-term clinical results.  The techniques for arthroscopic SCR using dermal allograft continue to improve; however, the operation remains technically demanding.  Patients with risk factors for irreparability and who might benefit from reconstruction of the superior capsule should be counseled about the operation as an additional, joint-preserving procedure that can be done in conjunction with arthroscopic, partial RC repair.

In a retrospective, case-series study, Pennington et al (2018) reported the findings of 88 consecutive shoulders with irreparable RCT that they treated with arthroscopic SCR using an acellular dermal allograft.  These researchers also presented the concept of superior capsular distance to quantitatively measure the decreased distance present upon restoration of superior capsular integrity.  A retrospective review was conducted of patients treated with arthroscopic SCR with a minimum 12-month follow-up.  Outcome analysis was performed via an internet-based outcome-tracking system to evaluate VAS and ASES scores.  Radiographic analysis of antero-posterior radiographs analyzed acromio-humeral interval and superior capsular distance.  Digital dynamometric strength and functional range of motion (ROM) assessments were also obtained.  The main inclusion criteria for patients in this analysis was all patients who underwent SCR during the time period of this report.  A total of 86 patients with an average age of 59.4 years presented with massive RCT (Cofield greater than 5 cm).  Outcome data revealed improvement in VAS (4.0 to 1.5), and ASES (52 to 82) scores at 1 year (p = 0.005).  Radiographic analysis showed increase in acromio-humeral interval (mean of 7.1 mm pre-operatively to mean of 9.7 mm at 1 year) (p = 0.049) and superior capsular distance (mean of 52.9 mm pre-operatively to mean of 46.2 mm at 1 year) (p = 0.011).  Strength improved significantly (forward flexion/abduction/external rotation of 4.8/4.1/7.7 lb pre-operatively to 9.8/9.2/12.3 lb at 1 year) as well as ROM (forward flexion/abduction of 120°/103° pre-operatively to 160°/159° at 1 year) (p = 0.044/p = 0.007/p = 0.02).  At follow-up, 90 % of patients were satisfied.  The authors concluded that this analysis revealed that arthroscopic SCR with acellular dermal allograft had been successful in decreasing pain and improving function in this patient subset.  Radiographic analysis has also shown a consistent and lasting decrease in superior capsular distance and increase in acromio-humeral interval, indicating maintenance of superior capsular stability.  Level of Evidence = IV.

In summary, there is insufficient evidence to support the use of acellular dermal extracellular matrix for shoulder capsular reconstruction.  Available data are mainly case-series studies with short-term follow-up.

Table: CPT Codes / HCPCS Codes / ICD-9 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

CPT codes not covered for indications listed in the CPB:

Microfracturing of the shoulder, application of acellular dermal extracellular matrix - no specific code

Total shoulder arthroplasty:

CPT codes covered if selection criteria are met :

23472 Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder) [not covered for those who have an irreparable rotator cuff tear]

HCPCS codes covered if selection criteria are met :

C1776 Joint device (implantable)

ICD-10 codes covered if selection criteria are met :

C40.00 - C40.02 Malignant neoplasm of scapula and long bones of upper limb [malignancy of glenohumeral joint or surrounding soft tissue]
C49.10 - C49.12 Malignant neoplasm of connective and other soft tissue of upper limb, including shoulder [malignancy of glenohumeral joint or surrounding soft tissue]
C76.40 - C76.42 Malignant neoplasm of upper limb
M05.00 - M05.9 Rheumatoid arthritis
M12.511 - M12.519 Traumatic arthropathy, shoulder
M19.011 - M19.019 Osteoarthrosis, localized, primary, shoulder region [not covered for those who have an irreparable rotator cuff tear]
M19.111 - M19.119 Post-traumatic osteoarthritis, shoulder
M19.211 - M19.219 Osteoarthrosis, localized, secondary, shoulder region
M24.811 - M24.819 Other specific joint derangement of shoulder, not elsewhere classified [crepitus]
M87.021 - M87.029 Idiopathic aseptic necrosis of humerus [head]
S42.001+ - S42.199+ [7th character K or P] Malunion or nonunion of fracture of shoulder
S42.201+ - S42.496+ Fracture of humerus

ICD-10 not covered for indications listed in the CPB:

M75.100 - M75.122 Unspecified rotator cuff tear or rupture of unspecified shoulder, not specified as traumatic

Reverse shoulder arthroplasty:

CPT codes covered if selection criteria are met :

23472 Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder) [reverse shoulder arthroplasty]

HCPCS codes covered if selection criteria are met :

C1776 Joint device (implantable)

ICD-10 codes covered if selection criteria are met :

C40.00 - C40.02 Malignant neoplasm of scapula and long bones of upper limb [reconstruction after a tumor resection]
C43.60 - C43.62, D03.60 - D03.63 Malignant melanoma of skin of upper limb, including shoulder [reconstruction after a tumor resection]
C44.601 - C44.609 Unspecified malignant neoplasm of skin of lupper limb, including shoulder [reconstruction after a tumor resection]
C49.10 - C49.12 Malignant neoplasm of connective and other soft tissue of upper limb, including shoulder [reconstruction after a tumor resection]
C76.40 - C76.42 Malignant neoplasm of upper limb [reconstruction after a tumor resection]
M12.811 - M12.819 Other specified arthropathies NEC, shoulder [glenohumeral arthropathy]
M75.50 - M75.52 Bursitis of shoulder
M75.100 - M75.102 Unspecified rotator cuff tear or rupture of shoulder, not specified as traumatic [rotator cuff syndrome]
M75.110 - M75.112 Incomplete rotator cuff tear or rupture of shoulder, not specified as traumatic
M75.120 - M75.122 Complete rotator cuff tear or rupture of shoulder, not specified as traumatic
S42.201+ - S42.296+ Fracture of upper end of humerus [not repairable or cannot be reconstructed with other techniques]
Z96.611 - Z96.619 Presence of artificial shoulder joint [failed hemiarthroplasty or failed total shoulder arthroplasty with failed rotator cuff that is nonrepairable]

Shoulder Hemiarthroplasty:

CPT codes covered if selection criteria are met :

23470 Arthroplasty, glenohumeral joint; hemiarthroplasty

HCPCS codes covered if selection criteria are met :

C1776 Joint device (implantable)

ICD-10 codes covered if selection criteria are met :

M05.00 - M05.9 Rheumatoid arthritis
M12.511 - M12.519 Traumatic arthropathy, shoulder
M19.011 - M19.019 Osteoarthrosis, localized, primary, shoulder region
M19.111 - M19.119 Post-traumatic osteoarthritis, shoulder
M19.211 - M19.219 Osteoarthrosis, localized, secondary, shoulder region
M24.811 - M24.819 Other specific joint derangement of shoulder, not elsewhere classified [crepitus]
M75.80 - M75.82 Other shoulder lesions [Rotator cuff tear arthropathy with severe rotator cuff tearing]
M87.021 - M87.029 Idiopathic aseptic necrosis of humerus [head] [without glenoid involvement]
S42.001+ - S42.199+ [7th character K or P] Malunion or nonunion of fracture of shoulder
S42.201+ - S42.496+ Fracture of humerus

Revision or replacement of shoulder arthroplasty prosthesis:

CPT codes covered if selection criteria are met :

23333 Removal of foreign body, shoulder; deep (subfascial or intramuscular)
23334 Removal of prosthesis, includes debridement and synovectomy when performed; humeral or glenoid component
23335 Removal of prosthesis, includes debridement and synovectomy when performed; humeral and glenoid components (eg, total shoulder)
23473 - 23474 Revision of total shoulder arthroplasty, including allograft when performed; humeral and/or glenoid component

HCPCS codes covered if selection criteria are met :

C1776 Joint device (implantable)

ICD-10 codes covered if selection criteria are met :

S43.001+ - S43.086 Subluxation and dislocation of shoulder joint; anterior, posterior or inferior
T84.038+ - T84.039+ Mechanical loosening of prosthetic joint [shoulder]
T84.018+ - T84.019 Broken internal joint prosthesis [shoulder]
T84.038+ - T84.039+ Mechanical loosening of other internal prosthetic joint [shoulder]
T84.59x+ Infection and inflammatory reaction due to other internal joint prosthesis [shoulder]

Shoulder arthrodesis:

CPT codes covered if selection criteria are met :

23800 Arthrodesis, glenohumeral joint
23802 Arthrodesis, glenohumeral joint; with autogenous graft (includes obtaining graft)

ICD-10 codes covered if selection criteria are met :

A15.0 - A19.9 Tuberculous infection
A80.0 - A80.9 Acute poliomyelitis [paralytic disorders of infancy]
C40.00 - C40.02 Malignant neoplasm of scapula and long bones of upper limb [resection of tumor] [resection of tumor]
C49.10 - C49.12 Malignant neoplasm of connective and other soft tissue of upper limb, including shoulder [resection of tumor] [resection of tumor]
G54.0 Brachial plexus disorders [with flail shoulder]
G80.0 - G80.9 Cerebral palsy [paralytic disorders of infancy]
M75.120 - M75.122 Complete rotator cuff tear or rupture of shoulder, not specified as traumatic
P11.4, P11.9, P14.2, P14.8 - P14.9 Other cranial and peripheral nerve injuries due to birth trauma [paralytic disorders of infancy]
S43.001+ - S43.086 Subluxation and dislocation of shoulder joint [recurrent]
S43.421+ - S43.429+ Sprain of rotator cuff capsule
Z96.611 - Z96.619 Presence of artificial shoulder joint [failed total shoulder arthroplasty]

ICD-10 codes not covered for indications listed in the CPB:

A00.0 - B99.9 Certain infectious and parasitic diseases [active infection of the joint, active systemic bacteremia or active skin infection]
G20 - G21.9 Parkinson's disease [rapidly progressive neurological disease]
G56.80 - G56.83 Other mononeuritis of upper limb [rapidly progressive neurological disease]
G58.7 Mononeuritis multiplex [rapidly progressive neurological disease]
G61.0 Guillain-Barre syndrome [rapidly progressive neurological disease]
L08.0 - L08.9 Other local infections of skin and subcutaneous tissue [active skin infection]
T56.0X1A - T56.94xS Toxic effect of metals
T78.49xA - T78.49xS Other allergy [allergy to components of the implant (e.g., cobalt, chromium or alumina]

The above policy is based on the following references:

  1. Farmer KW, Hammond JW, Queale WS, et al. Shoulder arthroplasty versus hip and knee arthroplasties: A comparison of outcomes. Clin Orthop Relat Res. 2007;455:183-189.
  2. American Academy of Orthopaedic Surgeons (AAOS). The treatment of glenohumeral joint osteoarthritis. Rosemont (IL): AAOS; December 4, 2009. Available at: http://www.guideline.gov/content.aspx?id=15488&search=shoulder+arthroplasty. Accessed September 24, 2012.
  3. Izquierdo R, Voloshin I, Edwards S, et al; American Academy of Orthopedic Surgeons. Treatment of glenohumeral osteoarthritis. J Am Acad Orthop Surg. 2010;18(6):375-382.
  4. Litchfield RB, McKee MD, Balyk R, et al.  Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for osteoarthritis of the shoulder: A prospective, randomized, double-blind clinical trial-A JOINTs Canada Project. J Shoulder Elbow Surg. 2011;20(4):529-536.
  5. Shoulder disorders. In: Hegmann KT, editor(s). Occupational medicine practice guidelines. Evaluation and management of common health problems and functional recovery in workers. 3rd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2011. Available at: http://www.guideline.gov/content.aspx?id=36626&search=shoulder+arthroplasty. Accessed September 24, 2012.
  6. American Academy of Orthopaedic Surgeons (AAOS). Shoulder joint replacement. Rosemont (IL): AAOS; December 2011. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00094. Accessed September 24, 2012.
  7. Sanchez-Sotelo J. Total shoulder arthroplasty. The Open Orthopaedics Journal. 2011(5):106-114. Available at: http://www.benthamscience.com/open/toorthj/articles/V005/SI0078TOORTHJ/106TOORTHJ.pdf. Accessed September 28, 2012.
  8. Singh JA, Sperling J, Buchbinder R, McMaken K. Surgery for shoulder osteoarthritis: A Cochrane systematic review. J Rheumatol. 2011;38(4):598-605.
  9. Carter MJ, Mikuls TR, Nayak S, et al. Impact of total shoulder arthroplasty on generic and shoulder-specific health-related quality-of-life measures: A systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012;94(17):e1271-e1279.
  10. Singh JA, Sperling J, Schleck C, et al. Periprosthetic fractures associated with primary total Shoulder arthroplasty and primary humeral head replacement: A thirty-three-year study. J Bone Joint Surg Am. 2012;94(19):1777-1785.
  11. Swedish Orthopedic Institute. Shoulder replacement. 2012. Available at: http://www.swedish.org/Services/Orthopedic-Institute/Orthopedic-Services/Joint-Replacement/Shoulder-Replacement#axzz26kjKPyTI. accessed September 28, 2012.
  12. Anderson BC. Glenohumeral osteoarthritis. Last reviewed August 2012. UpToDate Inc. Waltham, MA.
  13. Jones LC. Osteonecrosis (avascular necrosis of bone). Last reviewed August 2012. UpToDate Inc. Waltham, MA.
  14. Duquin TR, Jacobson JA, Sanchez-Sotelo J, et al. Unconstrained shoulder arthroplasty for treatment of proximal humeral nonunions. J Bone Joint Surg Am. 2012;94(17):1610-1617.
  15. Favard L, Katz D, Colmar M, et al. Total shoulder arthroplasty - arthroplasty for glenohumeral arthropathies: Results and complications after a minimum follow-up of 8 years according to the type of arthroplasty and etiology. Orthop Traumatol Surg Res. 2012;98(4 Suppl):S41-S47.
  16. Fevang BT, Lygre SH, Bertelsen G, et al. Good function after shoulder arthroplasty. Acta Orthop. 2012;83(5):467-473.
  17. Razmjou H, Holtby R, Christakis M, et al. Impact of prosthetic design on clinical and radiologic outcomes of total shoulder arthroplasty: A prospective study. J Shoulder Elbow Surg. 2013;22(2):206-214.
  18. Canale: Campbell’s Operative Orthopaedics. Tenth Edition. 2003. Eleventh Edition. 2007. Twelfth Edition. 2012.
  19. DeLee: DeLee and Drez’s Orthopaedic Sports Medicine. Third Edition. 2009.
  20. Elhassan B, Ozbaydar M, Diller D, et al. Soft-tissue resurfacing of the glenoid in the treatment of glenohumeral arthritis in active patients less than fifty years old. J Bone Joint Surg Am. 2009;91(2):419-424.
  21. Krishnan SG, Nowinski RJ, Harrison D, Burkhead WZ. Humeral hemiarthroplasty with biologic resurfacing of the glenoid for glenohumeral arthritis. Two to fifteen-year outcomes. J Bone Joint Surg Am. 2007;89(4):727-734.
  22. Krishnan SG, Reineck JR, Nowinski RJ, et al. Humeral hemiarthroplasty with biologic resurfacing of the glenoid for glenohumeral arthritis. Surgical technique. J Bone Joint Surg Am. 2008;90(Suppl 2): 9-19.
  23. Saltzman MD, Chamberlain AM, Mercer DM, et al. Shoulder hemiarthroplasty with concentric glenoid reaming in patients 55 years old or less. J Shoulder Elbow Surg. 2011;20(4):609-615.
  24. Wirth MA. Humeral head arthroplasty and meniscal allograft resurfacing of the glenoid. J Bone Joint Surg Am. 2009;91(5):1109-1119.
  25. American Academy of Orthopaedic Surgeons (AAOS). American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of glenohumeral joint osteoarthritis. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); December 4, 2009. Re-affirmed 2014. Available at: http://www.guideline.gov/content.aspx?id=15488&search=Shoulder+Arthroplasty Accessed September 3, 2015.
  26. Ferrel JR, Trinh TQ, Fischer RA. Reverse total shoulder arthroplasty versus hemiarthroplasty for proximal humeral fractures: A systematic review. J Orthop Trauma. 2015;29(1):60-68.
  27. Randelli P, Randelli F, Compagnoni R, et al. Revision reverse shoulder arthroplasty in failed shoulder arthroplasties for rotator cuff deficiency. Joints. 2015;3(1):31-37.
  28. Samitier G, Alentorn-Geli E, Torrens C, Wright TW. Reverse shoulder arthroplasty. Part 1: Systematic review of clinical and functional outcomes. Int J Shoulder Surg. 2015;9(1):24-31.
  29. Alentorn-Geli E, Samitier G, Torrens C, Wright TW. Reverse shoulder arthroplasty. Part 2: Systematic review of reoperations, revisions, problems, and complications. Int J Shoulder Surg. 2015;9(2):60-67.
  30. Gupta AK, Harris JD, Erickson BJ, et al. Surgical management of complex proximal humerus fractures-a systematic review of 92 studies including 4500 patients. J Orthop Trauma. 2015;29(1):54-59.
  31. Dezfuli B, King JJ, Farmer KW, et al. Outcomes of reverse total shoulder arthroplasty as primary versus revision procedure for proximal humerus fractures. J Shoulder Elbow Surg. 2016;25(7):1133-1137.
  32. Chalmers PN, Keener JD. Expanding roles for reverse shoulder arthroplasty. Curr Rev Musculoskelet Med. 2016;9(1):40-48.
  33. Shannon SF, Wagner ER, Houdek MT, et al. Reverse shoulder arthroplasty for proximal humeral fractures: Outcomes comparing primary reverse arthroplasty for fracture versus reverse arthroplasty after failed osteosynthesis. J Shoulder Elbow Surg. 2016;25(10):1655-1660.
  34. Leroux TS, Basques BA, Frank RM, et al. Outpatient total shoulder arthroplasty: A population-based study comparing adverse event and readmission rates to inpatient total shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(11):1780-1786.
  35. Lin DJ, Wong TT, Kazam JK. Shoulder arthroplasty, from indications to complications: What the radiologist needs to know. Radiographics. 2016;36(1):192-208.
  36. Patzer T, Hufeland M, Krauspe R. Irreparable rotator cuff tears. Debridement, partial reconstruction, tendon transfer or reversed shoulder arthroplasty. Orthopade. 2016;45(2):149-158.
  37. Garofalo R, Flanagin B, Castagna A, et al. Massive irreparable rotator cuff tear and associated deltoid tear. Does the reverse shoulder arthroplasty and deltoid repair be a possible option of treatment? J Orthop Sci. 2016;21(6):753-758.
  38. Virk MS, Nicholson GP, Romeo AA, et al. Irreparable rotator cuff tears without arthritis treated with reverse total shoulder arthroplasty. Open Orthop J. 2016;10:296-308.
  39. Thorsness R, Romeo A. Massive rotator cuff tears: Trends in surgical management. Orthopedics. 2016;39(3):145-151.
  40. Petrillo S, Longo UG, Papalia R, Denaro V, et al. Reverse shoulder arthroplasty for massive irreparable rotator cuff tears and cuff tear arthropathy: A systematic review. Musculoskelet Surg. 2017;101(2):105-112.
  41. Sevivas N, Ferreira N, Andrade R, et al. Reverse shoulder arthroplasty for irreparable massive rotator cuff tears: A systematic review with meta-analysis and meta-regression. J Shoulder Elbow Surg. 2017;26(9):e265-e277.
  42. Kang JR, Sin AT, Cheung EV. Treatment of massive irreparable rotator cuff tears: A cost-effectiveness analysis. Orthopedics. 2017;40(1):e65-e76. 
  43. Frank RM, Van Thiel GS, Slabaugh MA, et al. Clinical outcomes after microfracture of the glenohumeral joint. Am J Sports Med. 2010;38(4):772-781.
  44. Gross CE, Chalmers PN, Chahal J, et al. Operative treatment of chondral defects in the glenohumeral joint. Arthroscopy. 2012;28(12):1889-1901.
  45. Milano G, Saccomanno MF, Careri S, et al. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: A prospective randomized study. Arthroscopy. 2013;29(5):802-810.
  46. Ely EE, Figueroa NM, Gilot GJ. Biomechanical analysis of rotator cuff repairs with extracellular matrix graft augmentation. Orthopedics. 2014;37(9):608-614.
  47. Lee B, Acevedo D, Mirzayan R. Reconstruction of the acromioclavicular joint, its superior capsule, and coraco-clavicular ligaments using an inter-positional acellular dermal matrix and tibialis tendon allograft. Techniques in Shoulder & Elbow Surgery. 2014;15(3):79-86.
  48. Mirzayan R, Conroy C, Sethi P. Distal biceps repair with acellular dermal graft augmentation. Techniques in Shoulder & Elbow Surgery. 2015:16(3):89-92.
  49. Gilot GJ, Attia AK, Alvarez AM. Arthroscopic repair of rotator cuff tears using extracellular matrix graft. Arthrosc Tech. 2014;3(4):e487-e489.
  50. Gilot GJ, Alvarez-Pinzon AM, Barcksdale L, et al. Outcome of large to massive rotator cuff tears repaired with and without extracellular matrix augmentation: A prospective comparative study. Arthroscopy. 2015;31(8):1459-1465.
  51. Levenda AC, Sanders NR. A simplified approach for arthroscopic repair of rotator cuff tear with dermal patch augmentation. Advances in Orthopedic Surgery. 2015, Article ID 423949.
  52. Katthagen JC, Tahal DS, Millett PJ. Arthroscopic capsule reconstruction for irreparable rotator cuff tears. Orthopedics Today. 2016:36(3):13-15.
  53. Petri M, Warth RJ, Horan MP, et al. Outcomes after open revision repair of massive rotator cuff tears with biologic patch augmentation. Arthroscopy. 2016;32(9):1752-1760.
  54. Hunnebeck SM, Magosch P, Habermeyer P, et al. Chondral defects of the glenohumeral joint: Long-term outcome after microfracturing of the shoulder. Obere Extrem. 2017;12(3):165-170.
  55. Hirahara AM, Andersen WJ, Panero AJ. Superior capsular reconstruction: Clinical outcomes after minimum 2-year follow-up. Am J Orthop (Belle Mead NJ). 2017;46(6):266-278.
  56. Hartzler RU, Burkhart SS. Superior capsular reconstruction. Orthopedics. 2017;40(5):271-280.
  57. Frehner F, Benthien JP. Microfracture: State of the art in cartilage surgery? Cartilage. 2017 Apr 1: [Epub ahead of print].
  58. Wang KC, Frank RM, Cotter EJ, et al. Long-term clinical outcomes after microfracture of the glenohumeral joint: Average 10-year follow-up. Am J Sports Med. 2018;46(4):786-794.
  59. Marin SD, Martin TL. Management of rotator cuff tears. UpToDate Inc., Waltham, MA. Last reviewed July 2018.
  60. Pennington WT, Bartz BA, Pauli JM, et al. Arthroscopic superior capsular reconstruction with acellular dermal allograft for the treatment of massive irreparable rotator cuff tears: Short-term clinical outcomes and the radiographic parameter of superior capsular distance. Arthroscopy. 2018;34(6):1764-1773.