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Aetna Aetna
Clinical Policy Bulletin:
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 ADLs from injury due to 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 six months duration that interferes with activities of daily living: and
      4. Radiographic evidence of destructive degenerative joint disease (as evidence by two 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 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 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 [Activities of daily living (ADLs) diminished despite completing a plan of care]; and
        5. intraarticular injections of steroids into the shoulder (optional); and
        6. For rheumatoid arthritis only, anti-cytokine agents (e.g., etanercept, infliximab) and nonbiologic DMARDs (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 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 nonrepairable; or
    4. Reconstruction after a tumor resection; or
    5. 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 six months duration that interferes with ADLs (six 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 [Activities of daily living (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).
       
  3. 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 two 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 six months duration that interferes with ADLs (six 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 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 [Activities of daily living (ADLs) diminished despite completing a plan of care]; and
      5. intraarticular injections of steroids into the shoulder (optional); and
         
    3. Member does not have a paralytic disorder of the shoulder.
       
  4. 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 ADLs):
     
    1. Aseptic loosening of one or more prosthetic components confirmed by imaging, or
    2. Fracture of one or more components of the prosthesis confirmed by imaging, or
    3. Confirmed periprosthetic infection by gram stain and culture, or
    4. Instability of the glenoid or humeral components; or
    5. Migration of the humeral head.
       
  5. Total shoulder arthroplasty, hemiarthroplasty, reverse shoulder arthroplasty or arthroplasty revision or replacement is considered 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).
       
  6. 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.
  7. Aetna considers total shoulder arthroplasty, shoulder hemiarthroplasty, reverse shoulder arthroplasty, and shoulder arthroplasty revision or replacement experimental and investigational for all other indications. 
  8. 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 ADLs; 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 nonsurgical 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 [Activities of daily living (ADLs) diminished despite completing a plan of care]; and
      4. assistive device use, as appropriate.
         
  9. For members with significant conditions or co-morbidities, the risk/benefit of shoulder arthrodesis should be appropriately addressed in the medical record.

See also CPB 0661 - Hip and Shoulder 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 (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 (2012) compared clinical and radiologic outcomes of TSA using 3 different prosthetic designs: (i) the Neer II system, (ii) the Bigliani-Flatow (BF), and (iii) 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 fifty years of age, as there was concern that this type of procedure was leading to poor outcomes. Between 2000 and 2006, thirteen patients with an average age of thirty-four years underwent soft-tissue resurfacing of the glenoid and humeral head arthroplasty. Achilles tendon allograft was used in eleven patients; fascia lata autograft, in one; and anterior shoulder joint capsule, in one. Three patients had resurfacing of the humeral head with a stemless resurfacing implant, and ten patients had a hemiarthroplasty. The patients were followed for a minimum of two years or until failure, and the duration of follow-up averaged forty-eight 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. en of the thirteen patients required a revision total shoulder arthroplasty at a mean of fourteen months (range, six to thirty-four months) postoperatively. 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 three patients who did not have a revision arthroplasty, one had good function, pain relief, and an improved range of motion; however, the postoperative course of the other two 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 fifty years of age, as the clinical outcome is poor. Moreover, no evidence indicated that the graft acts as a durable bearing surface.”

In 2007, Krishnan and colleagues published the two to fifteen year outcomes of thirty-four patients (thirty-six shoulders) who were managed with biologic glenoid resurfacing and humeral head replacement either with cement (ten shoulders) or without cement (twenty-six shoulders). The study group included thirty men and four women with an average age of fifty-one years whose diagnoses included primary glenohumeral osteoarthritis (eighteen shoulders), postreconstructive arthritis (twelve), posttraumatic arthritis (five), and osteonecrosis (one). Anterior capsule was used for seven shoulders, autogenous fascia lata for eleven, and Achilles tendon allograft for eighteen. The mean American Shoulder and Elbow Surgeons score was 39 points preoperatively and 91 points at the time of the most recent follow-up. According to Neer's criteria, the result was excellent for eighteen shoulders, satisfactory for thirteen, and unsatisfactory for five. Glenoid erosion averaged 7.2 mm and appeared to stabilize at five years. There were no revisions for humeral component loosening. Complications included infection (two patients), instability (three patients), brachial plexitis (one patient), and deep-vein thrombosis (one patient). Factors that appeared to be associated with unsatisfactory results were the use of capsular tissue as the resurfacing material and infection

 
CPT Codes / HCPCS Codes / ICD-9 Codes
ICD-9 codes not covered for indications listed in the CPB:
001.0 - 139.8 Infectious and Parasitic Diseases [active infection of the joint, active systemic bacteremia or active skin infection]
332.0 Paralysis agitans [rapidly progressive neurological disease]
354.5 Mononeuritis multiplex [rapidly progressive neurological disease]
354.8 Other mononeuritis of upper limb [rapidly progressive neurological disease]
357.0 Acute infective polyneuritis [rapidly progressive neurological disease]
686.00 - 686.9 Pyoderma [active skin infection]
985.6 Toxic effect of chromium
985.8 Toxic effect of other specified metals
995.3 Allergy, unspecified, NEC [allergy to components of the implant (e.g., cobalt, chromium or alumina]
Total shoulder arthroplasty:
CPT codes covered if selection criteria are met :
23472
HCPCS codes covered if selection criteria are met :
C1776 Joint device (implantable)
ICD-9 codes covered if selection criteria are met :
170.4 Malignant neoplasm of scapula and long bones of upper limb[malignancy of glenohumeral joint or surrounding soft tissue]
171.2 Malignant neoplasm of connective and other soft tissue of upper limb, including shoulder [malignancy of glenohumeral joint or surrounding soft tissue]
195.4 Malignant neoplasm of upper limb [malignancy of glenohumeral joint or surrounding soft tissue]
714.0 Rheumatoid arthritis
715.11 Osteoarthrosis, localized, primary, shoulder region
715.21 Osteoarthrosis, localized, secondary, shoulder region
715.31 Osteoarthrosis, localized, not specified whether primary or secondary, shoulder region
715.91 Osteoarthrosis, unspecified whether generalized or localized, shoulder region
716.11 Traumatic arthropathy, shoulder region
719.61 Other symptoms referable to joint of shoulder region [crepitus]
733.41 Aseptic necrosis of bone, head of humerus
733.81 Malunion of fracture
733.82 Nonunion of fracture
812.12 Fracture of anatomical neck of humerus, open
812.20 Fracture of unspecified part of humerus, closed
Other ICD-9 codes related to the CPB:
719.41 Pain in joint involving shoulder region
Reverse shoulder arthroplasty:
CPT codes covered if selection criteria are met :
23472
HCPCS codes covered if selection criteria are met :
C1776 Joint device (implantable)
ICD-9 codes covered if selection criteria are met :
170.4 Malignant neoplasm of scapula and long bones of upper limb [reconstruction after a tumor resection]
171.2 Malignant neoplasm of connective and other soft tissue of upper limb, including shoulder [reconstruction after a tumor resection]
172.6 Malignant melanoma of skin of upper limb, including shoulder [reconstruction after a tumor resection]
173.60 - 173.69 Other and unspecified malignant neoplasm of skin of upper limb, including shoulder [reconstruction after a tumor resection]
195.4 Malignant neoplasm of upper limb [reconstruction after a tumor resection]
716.91 Unspecified arthropathy involving shoulder region [glenohumeral arthropathy]
726.10 Unspecified disorders of bursae and tendons in shoulder region [rotator cuff syndrome]
726.13 Partial tear of rotator cuff
727.61 Complete rupture of rotator cuff
812.00 - 812.19 Fracture of upper end of humerus, closed or opened [not repairable or cannot be reconstructed with other techniques]
V43.61 Shoulder joint replacement status [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
HCPCS codes covered if selection criteria are met :
C1776 Joint device (implantable)
ICD-9 codes covered if selection criteria are met :
714.0 Rheumatoid arthritis
715.11, 715.21, 715.31, 715.91 Osteoarthrosis, localized, primary, secondary, unspecified shoulder region
716.11 Traumatic arthropathy, shoulder region
719.61 Other symptoms referable to joint of shoulder region [crepitus]
726.19 Other specified disorders of shoulder [Rotator cuff tear arthropathy with severe rotator cuff tearing]
733.41 Aseptic necrosis of head of humerus [without glenoid involvement]
733.81 - 733.82 Malunion or nonunion of fracture
812.12 Fracture of anatomical neck of humerus, open
812.20 Fracture of unspecified part of humerus, closed
Revision or replacement of shoulder arthroplasty prosthesis:
CPT codes covered if selection criteria are met :
23333
23334
23335
23473 - 23474
HCPCS codes covered if selection criteria are met :
C1776 Joint device (implantable)
ICD-9 codes covered if selection criteria are met :
831.00 - 831.03 Closed dislocation of shoulder; anterior, posterior or inferior
996.41 Mechanical loosening of prosthetic joint
996.43 Broken prosthetic joint implant
996.41 Peri-prosthetic fracture around prosthetic joint
996.66 Infection and inflammatory reaction due to internal joint prosthesis
Shoulder arthrodesis:
CPT codes covered if selection criteria are met :
23800
23802
ICD-9 codes covered if selection criteria are met :
010.0 - 041.9 Tuberculous infection
045.10 - 045.13 Acute poliomyelitis with other paralysis [paralytic disorders of infancy]
170.4 Malignant neoplasm of scapula and long bones of upper limb [resection of tumor] [resection of tumor]
171.2 Malignant neoplasm of connective and other soft tissue of upper limb, including shoulder [resection of tumor] [resection of tumor]
353.0 Brachial plexus [with flail shoulder]
343.0 - 343.9 Infantile cerebral palsy[paralytic disorders of infancy]
727.61 Complete rupture of rotator cuff
767.7 Other cranial and peripheral nerve injuries due to birth trauma [paralytic disorders of infancy]
831.00 - 831.03 Closed dislocation of shoulder [recurrent]
840.4 Rotator cuff (capsule) sprain and strain
V43.61 Shoulder joint replacement status [failed total shoulder arthroplasty]


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. 2012 Jul 20. [Epub ahead of print]
  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 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, 91(2): 419-24  2009.
  21. Krishnan SG et al. Humeral hemiarthroplasty with biologic resurfacing of the glenoid for glenohumeral arthritis. Two to fifteen-year outcomes. J Bone Joint Surg Am; 89(4): 727-34  2007.
  22. Krishnan SG et al. Humeral hemiarthroplasty with biologic resurfacing of the glenoid for glenohumeral arthritis. Surgical technique. J Bone Joint Surg Am, 90 Suppl 2: 9-19  2008.
  23. Saltzman MD et al. Shoulder hemiarthroplasty with concentric glenoid reaming in patients 55 years old or less. J Shoulder Elbow Surg; 20(4): 609-15  2011.
  24. Wirth MA. Humeral head arthroplasty and meniscal allograft resurfacing of the glenoid. J Bone Joint Surg Am, 91(5): 1109-19  2009.


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