Elbow Arthroplasty

Number: 0857

Policy

Aetna considers total elbow arthroplasty medically necessary for the treatment of the following:

• Displaced intra-articular distal humerus fracture that is osteoporotic or not amenable to internal fixation; or
• Elbow pain unresponsive to medical therapy, when radiographs demonstrate destruction of articular cartilage or gross deformity, and there is inability to use the extremity for functions of daily living; or or because of pain, motion loss, or instability; or
• Elbow ankylosis after sepsis or trauma; or
• Salvage / revision of a failed implant.
  

Aetna considers arthroplasty with a metal radial head medically necessary in the treatment of an unreconstructible comminuted fracture of the radial head; the clinical literature has shown that silicone implants are not resistant to wear.

Aetna considers the following procedures experimental and investigational because their effectiveness has not been established:

• Elbow hemiarthoplasty for the treatment of humerus fractures
• Total elbow arthroplasty for the treatment of reconstructible comminuted radial head fractures
• Total elbow arthroplasty for the treatment of osteoarthritis secondary to fracture.

Background

Arthroplasty is the surgical reconstruction or replacement of a malformed or degenerated joint that is done to relieve pain and restore range of motion to the joint.Total elbow arthroplasty is indicated for the treatment of pain unresponsive to medical therapy, when radiographs demonstrate destruction of articular cartilage or gross deformity, inability to use the extremity for functions of daily living because of pain, motion loss, or instability, refractory sepsis, elbow ankylosis after sepsis or trauma and salvage/revision of a failed implant.

A fracture of the radial head is a complete or incomplete break in the radius occurring at its head, the disc-shaped portion of the bone closest to the elbow. A comminuted fracture involves the entire radial head, which separates into discrete fragments. This type of fracture involves the head of the radius, the elbow joint, and the soft tissue surrounding the fracture site, including nerves, tendons, ligaments, blood vessels, cartilage, and muscles. The mechanism of injury is usually indirect, resulting from a fall onto the palm of the hand, in which the upper limb is in a variable position of flexion of the elbow, and the forearm in pronosupination. Patients present with pain, swelling, limited motion, especially forearm rotation. 

Based on the clinical evidence, arthroplasty with a metal radial head is an acceptable alternative in the treatment of an unreconstructible comminuted fracture. The clinical literature has shown that silicone implants are not resistant to wear.

Burkhart et al (2011) evaluated the objective and subjective outcomes, as well as the radiographic results after elbow hemiarthroplasty (HA) for comminuted distal humerus fractures in elderly patients.  A total of 10 female patients with a mean age of 75.2 years were treated with elbow HA either for osteoporotic, comminuted distal humerus fractures (n = 8) or for early failed osteosynthesis of distal humerus fractures (n = 2).  The mean follow-up period was 12.1 months.  All patients were examined and evaluated using the Mayo Elbow Performance Score (MEPS) and the Disabilities of the Arm, Shoulder, and Hand (DASH) score.  Radiographic post-operative outcomes were assessed performing antero-posterior and lateral radiographs of the injured elbow.  According to the MEPS, 9 patients achieved "good" to "excellent results" and only 1 patient revealed a "fair" clinical outcome.  The mean DASH score was 11.5 (range of 0 to 30).  The flexion of the affected elbow was 124.5° (range of 95 to 140°), the extension deficit was 17.5° (range of 5 to 30°), the pronation was 80.5° (range of 60 to 90°), and the supination was 79.5° (range of 50 to 90°).  The following post-operative complications were seen: 1 triceps weakness, 1 transient ulnar nerve irritation, 1 superficial wound infection, and 2 heterotopic ossifications.  None of the patients required explantation of the prosthesis.  There was no evidence of loosening, radiolucency, or proximal bone resorption, whereas 1 patient developed progressive osteoarthritis of the proximal ulnar and radial articulation.  The authors concluded that elderly patients treated with elbow HA revealed good to excellent short-term clinical outcomes.  A high rate of complications occurred but most complications found were minor and re-operation rate was low.  These researchers noted that these findings must be regarded as a report on their first experience with HA.  As cartilage wear is just a question of time especially in active patients, these investigators cautiously recommended HA only for elderly and multi-morbid low-demand patients.  The main drawbacks of this study were its small sample size and short-term follow-up.  Its findings need to be validated by well-designed studies.

Argintar et al (2012) stated that total elbow arthroplasty is the current gold standard of treatment for unreconstructable distal humerus fractures; however, longevity of the implant remains a concern in younger, more active patients.  Distal humerus HA offers an alternative and may allow for more durable results.  The authors retrospectively evaluated the short-term clinical outcomes of 10 patients who underwent elbow HA for distal humerus fractures.  This short-term review suggested that distal humerus HA may be an effective treatment for certain distal humerus fractures.  The authors concluded that additional studies must be conducted to further define the role of elbow HA for the treatment of complex fractures of the distal humerus.

Verbeek et al (2012) noted that the optimal surgical management of dislocated 3- and 4-part fractures of the proximal humerus in elderly patients remains unclear.  Most used techniques are HA and angle-stable locking compression plate osteosynthesis.  In the current literature there is no evidence available presenting superior results between HA and angle-stable locking compression plate osteosynthesis in terms of speed of recovery, pain, patient satisfaction, functional outcome, quality of life or complications.  These researchers stated that a randomized controlled multi-center trial will be conducted.  Patients older than 60 years of age with a dislocated 3- or 4-part fracture of the proximal humerus as diagnosed by X-rays and CT-scans will be included.  Exclusion criteria are a fracture older than 14 days, multiple co-morbidity, multi-trauma, a pathological fracture, previous surgery on the injured shoulder, severely deranged function caused by a previous disease, "head-split" proximal humerus fracture and unwillingness or inability to follow instructions.  Participants will be randomized between surgical treatment with HA and angle-stable locking compression plate osteosynthesis.  Measurements will take place pre-operatively and 3 months, 6 months, 9 months, 12 months and 24 months post-operatively.  Primary outcome measure is speed of recovery of functional capacity of the affected upper limb using the DASH score.  Secondary outcome measures are pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.  Data will be analyzed on an intention-to-treat basis, using uni-variate and multi-variate analyses.  The authors concluded that both HA and angle-stable locking compression plate osteosynthesis are used in the current treatment of dislocated 3-and 4-part fractures of the proximal humerus.  There is a lack of level-1 studies comparing these 2 most-used surgical treatment options.  This randomized controlled multi-center trial has been designed to determine which surgical treatment option provides the fastest recovery of functional capacity of the affected upper limb, and will provide better outcomes in pain, satisfaction, shoulder function, quality of life, radiological evaluation and complications.

Hohman et al (2014) reviewed clinical and radiographic results in patients with distal humeral HA.  Distal humeral HA with the Latitude prosthesis (Tornier, Saint-Ismier, France) was performed in 8 patients (mean age of 64 years; age range of 33 to 75 years) for unreconstructible fractures of the distal humerus or salvage of failed internal fixation.  Clinical outcomes were assessed with the American Shoulder and Elbow Surgeons elbow instrument; MEPS; and DASH questionnaire at a mean of 36 months.  Radiologic assessment included radiographs and computed tomography to evaluate olecranon wear and densitometry (dual-energy x-ray absorptiometry).  Range of motion, pain, and elbow satisfaction were recorded, and descriptive statistics were used for analysis.  A total of 7 patients were available to participate in the follow-up examination.  Acute cases (5 patients) scored better than salvage cases (2 patients) on the MEPS (80 points [range of 67 to 95 points] and 65 points [range of 50 to 80 points], respectively) and DASH score (31 points [range of 2.5 to 68 points] and 39 points [range of 17 to 62 points], respectively).  The mean arc of elbow flexion and extension was 96°(range of 70° to 130°), with mean flexion of 120° (range of 90° to 135°) and a mean extension loss of 19° (range of 5° to 30°).  The mean arc of forearm rotation was 160° (range of 140° to 180°).  Re-operation was required in 4 patients because of painful retained hardware; 5 patients reported pain with activities of daily living.  The authors concluded that distal humeral HA should be used with caution until such time as longer-term outcome studies are able to show the effectiveness of this procedure.

Sebastia-Forcada et al (2014) noted that there is no consensus on what type of arthroplasty is best for the treatment of complex proximal humeral fractures in elderly patients.  In a prospective study, these researchers compared the outcomes of reverse shoulder arthroplasty (RSA) and HA.  A total of 62 patients (older than 70 years) were randomized to either RSA (31 patients) or HA (31 patients).  One HA patient died at 1 year, and she was excluded.  The mean follow-up was 28.5 months (range of 24 to 49).  Compared with HA patients, RSA patients had significantly higher (p = 0.001) mean University of California-Los Angeles (29.1 versus 21.1) and Constant (56.1 versus 40.0) scores, forward elevation (120.3° versus 79.8°), and abduction (112.9° versus 78.7°) but no difference in internal rotation (2.7° versus 2.6°; P = .91).  The DASH score was higher in the HA patients (17 versus 29; p = 0.001).  In the HA group, 56.6 % of tuberosities healed and 30 % resorbed.  Patients with failure of tuberosities had significantly worse functional outcomes.  There were 2 complications (intra-operative humeral fracture and superficial infection).  One patient was manipulated under general anesthesia because of post-operative stiffness.  Six patients with HA had proximal migration that required revision to RSA.  In the RSA group, 64.5 % of tuberosities healed and 13.2 % resorbed.  Functional outcome was irrespective of healing of the tuberosities.  Notching was observed in only 1 RSA patient; 1 patient developed a hematoma and another developed a deep infection requiring a 2-stage revision to another RSA.  The authors concluded that RSA resulted in better pain and function and lower revision rate.  Revision from HA to RSA does not appear to improve outcomes.

Mansat et al (2014) stated that fractures of the distal humerus account for 5 % of osteoporotic fractures in subjects older than 60 years.  A history of osteoporosis, co-morbidities, and joint comminution make their management difficult.  The therapeutic options are limited to functional treatments, osteosynthesis, or either partial or total arthroplasty.  Functional treatment of distal humerus fractures in the elderly subject provides inconsistent results, often with persistence of pain with a stiff or unstable elbow.  Osteosynthesis remains the reference treatment for these fractures, following the principle of stable and rigid osteosynthesis allowing early mobilization.  However, joint comminution and a history of osteoporosis occasionally make it impossible to meet this objective, with a considerable rate of complications and surgical revisions.  The authors concluded that total elbow arthroplasty remains an alternative to osteosynthesis with very satisfactory immediate results restoring a painless, stable, and functional elbow.  These results seem reproducible and sustainable over time.  The complication rate is not uncommon with an approximately 10 % surgical revision rate.  Moreover, elbow HA remains to be validated in this indication.

Giannicola et al (2014) prospectively evaluated preliminary results of the Discovery Elbow System (DES; Biomet, Warsaw, IN) used for acute distal humerus fractures and post-traumatic conditions. These researchers analyzed 24 patients (9 men and 15 women), with a mean age of 69 years (range of 45 to 89). Ten had comminuted distal humerus fractures (group I), and 14 had severe post-traumatic arthritis, chronic instability, or nonunion (group II). Clinical and radiographic evaluations were performed. The pre-operative (group II) and post-operative (both groups) evaluations were assessed with the MEPS and Mayo Elbow Performance Index (MEPI), the Quick Disabilities of the Arm, Shoulder, and Hand score, and the modified American Shoulder and Elbow Surgeons score. Patient satisfaction was evaluated on a 4-point scale. Mean follow-up was 41 months (range of 29-63). At the last evaluation, average flexion, extension, pronation, and supination were 136°, 17°, 80°, and 83°, respectively. The average MEPS, Quick Disabilities of the Arm, Shoulder, and Hand score, and the modified American Shoulder and Elbow Surgeons score were 96, 20, and 84, respectively, and without significant inter-group differences. According to the MEPI, there were 20 excellent, 3 good, and 1 fair result; 20 patients were very satisfied or satisfied with the outcome. A significant increase in the functional scores was observed in group II compared with pre-operative results. Radiological evaluation showed 1 patient with progressive radiolucency and 1 with a non-progressive radiolucency at the final follow-up. No mechanical failures were observed. Two transient ulnar neuropathies, 1 wound infection, and 1 epicondyle fracture were observed. The authors concluded that the DES yielded promising 2- to 5-year results in the treatment of acute fractures and post-traumatic conditions regarding pain relief, functional improvement, and patient satisfaction, achieving excellent results in most cases. They stated that the DES may represent an effective linked-implant option for total elbow replacement in such patients; however, long-term studies are needed.

Alizadehkhaiyat et al (2015) noted that total elbow arthroplasty (TEA) is increasingly used for the treatment of advanced elbow conditions to reduce pain and improve function. However, TEA is still associated with a higher complication rate than total hip and knee arthroplasty despite advances in the design and surgical techniques. This prospective clinical study reported the outcome of the DES, which has been in clinical use in the United Kingdom since 2003. The study included a total of 100 Discovery Elbows (April 2003 to January 2010) with a minimum 2-year follow-up, including 75 primary and 25 revisions (60 % women and 40 % men; mean age of 62 years). Outcome was assessed by means of the Liverpool Elbow Score, pain experience, patient satisfaction, range of motion (ROM), and radiographic imaging. The mean follow-up period was 48.5 months (range of 24 to 108). The Liverpool Elbow Score improved from 3.79 to 6.36 (p < 0.001). The percentage of pain-free patients was substantially increased from 7 % pre-operatively to 64 % at the final follow-up. The patient satisfaction rate was over 90 %. The flexion-extension arc and pronation-supination arc increased from 72° to 93° and from 86° to 111°, respectively (p < 0.001). Major post-operative complications included deep infection (2 %), progressive aseptic loosening requiring revision (primary, 5 %; revision 12 %), persistent ulnar neuropathy (3 %), and peri-prosthetic fracture (primary, 6.8 %; revision, 8 %). The authors concluded that the DES resulted in improved function, reduced pain, and high patient satisfaction. Moreover, they stated that long-term results are needed to evaluate the survivorship of this system.

Heijink et al (2015) noted that treatment of comminuted distal humeral fractures remains challenging. Open reduction-internal fixation remains the preferred treatment, but is not always feasible. In selected cases with non-reconstructable or highly comminuted fractures, total elbow arthroplasty has been used, however, also with relatively high complication and failure rates. Distal humerus prosthetic hemiarthroplasty (DHA) may be an alternative in these cases. These investigators reported the mid-term results of 6 patients who were treated by DHA for acute and salvage treatment of non-reconstructable fractures of the distal humerus. All 6 patients were treated by DHA for acute and salvage treatment of non-reconstructable fractures of the distal humerus. Medical records were reviewed, and each patient was seen in the office. Mean follow-up was 54 months (range of 21 to 76). Implant survival was 100 %; 3 were pain-free and 3 had mild or moderate residual pain. Average flexion-extension arc was 95.8° (range of 70° to 115°) and average pronation-supination arc was 165° (range of 150° to 180°). In 3, there was some degree of instability, which was symptomatic in 1. One had motoric and sensory sequelae of a partially recovered traumatic ulnar nerve lesion. According to the MEPS, there were 3 excellent, 1 good and 2 poor results; 4 were satisfied with the final result, and 2 were not. The authors concluded that in this case series of 6 patients with DHA for non-reconstructable distal humerus fractures, favorable mid-term follow-up results were seen; however, complications were also observed.

Hemiarthroplasty for Distal Humeral Fractures

Nestorson et al (2015) reported their experience of performing an elbow hemiarthroplasty in the treatment of comminuted distal humeral fractures in the elderly patients. A cohort of 42 patients (3 men and 39 women, mean age of 72 years; range of 56 to 84) were reviewed at a mean of 34.3 months (range of 24 to 61) after surgery.  Functional outcome was measured with the MEPS and ROM; DASH was used as a patient rated evaluation.  Complications and ulnar nerve function were recorded.  Plain radiographs were obtained to assess prosthetic loosening, olecranon wear and heterotopic bone formation.  The mean extension deficit was 23.5° (range of 0° to 60°) and mean flexion was 126.8° (range of 90° to 145°) giving a mean arc of 105.5° (range of 60° to 145°).  The mean MEPS was 90 (range of 50 to 100) and a mean DASH score of 20 (range of 0 to 63); 4 patients had additional surgery for limited ROM and 1 for partial instability.  One elbow was revised due to loosening, 2 patients had sensory ulnar nerve symptoms, and radiographic signs of mild olecranon wear was noted in 5 patients.  The authors concluded that elbow hemiarthroplasty for comminuted intra-articular distal humeral fractures produced reliable medium-term results with functional outcome and complication rates, comparable with open reduction and internal fixation and TEA.  The main drawbacks of this study were its relatively small sample size (n = 42) and mid-term follow-up (34.3 months). 

Comminuted Radial Head Fractures

In a retrospective study, Moghaddam and colleagues (2016) examined how well the modular metallic radial head implant EVOLVE prosthesis restores functional ROM and stability of the elbow in acute care. A total of 85 patients with comminuted radial head fractures and associated injuries received treatment with an EVOLVE prosthesis between May 2001 and November 2009; 75 patients were available for follow-up.  On average, patients were followed for 41.5 months (median of 33.0; 4.0 to 93.0).  Outcome assessment was done on the basis of pain, ROM, strength, radiographic findings, and functional rating scores such as Broberg and Morrey, the MEPI, and DASH.  Overall, there were 2 (2.7 %) Mason II fractures, 21 (28 %) Mason III fractures, and 52 (69.3 %) Mason IV fractures.  Arbeitsgemeinschaft fur osteosynthesefragen (AO) classification was also determined.  Average scores for the cohort were as follows: Morrey, 85.7 (median of 90.2; range of 44.4 to 100); MEPI, 83.3 (85.0; 40.0 to 100); and DASH 26.1 points (22.5; 0.0 to 75.8).  Mean flexion/extension in the affected joint was 125.7°/16.5°/0° in comparison to the non-injured side 138.5°/0°/1.2°.  Mean pronation/supination was 70.5°/0°/67.1° in comparison to the non-injured side 83.6°/0°/84.3°.  Handgrip strength of the injured compared to the non-injured arm was 78.8 %.  The following complications were also documented: 58 patients had peri-prosthetic radiolucency shown to be neither clinically significant nor relevant according to evaluated scores; 26 patients had moderate or severe peri-articular ossification, and scored substantially worse according to MEPI and Morrey.  Four patients required revisional surgery due to loosening of the prosthesis and chronic pain.  In addition, 1 patient required a neurolysis of the ulnar nerve, 1 developed a neobursa, and 1 had extensive swelling and blistering.  The time interval between injury and treatment appeared to have an effect on results; 35 patients were treated within the first 5 days after accident and showed better results than the 40 patients who were treated after 5 days.  The authors concluded that comminuted radial head fractures with elbow instability can be treated well with a modular radial head prosthesis, which restored stability in acute treatment.  They stated that the modular radial head arthroplasty used in this study showed promising findings in short to mid-term results.

Furthermore, the American Academy of Orthopaedic Surgeons’ guideline and evidence report on "The treatment of distal radius fractures" (AAOS, 2009) did not mention elbow arthroplasty as a therapeutic option.

Fowler and colleagues (2016) stated that most current series of radial head arthroplasty (RHA) included small numbers of patients with short- to medium-term follow-up and significant heterogeneity in patients, treatments, and outcome measures.  These investigators reviewed outcomes for RHA based on injury chronicity, injury pattern, and type of implant used.  These researchers systematically searched electronic databases for studies containing RHA or radial head replacement and identified 19 studies for inclusion in the analysis.  For each included study, a composite mean was obtained for MEPS and ROM.  Outcomes were said to differ significantly if their confidence intervals did not overlap.  The MEPS for acute treatment (90) was higher than that for delayed treatment (81).  There was no difference in the pooled MEPS between the isolated (89) and complex injury pattern (87) groups or implant material.  There was no difference in ROM between the acute and delayed or isolated and complex groups, but the average degree of pronation was higher in patients treated with titanium implants (76°) compared with cobalt chromium implants (66°).  The authors concluded that the findings of this systematic review suggested that outcomes were improved following acute arthroplasty for treatment of radial head fractures compared with delayed treatment, based on MEPS.  The lack of other significant differences detected was likely due to the significant heterogeneity and inadequate power in current studies.  They stated that further prospective studies isolating the different variables are needed to determine their true effect on outcomes.

Sun and associates (2016) noted that open reduction and internal fixation (ORIF) and RHA are the most common operative treatments in patients with radial head fractures.  In a meta-analysis, these investigators determined the effectiveness of RHA and ORIF treatments in patients with radial head fractures (modified Mason type III and IV).  They conducted a computerized search of 5 electronic databases from their inception to July 2015.  All clinical trials comparing ORIF versus RHA treatment in patients with radial head fractures were included.  These researchers evaluated the primary outcomes included elbow functional evaluation criteria by Broberg and Morrey, elbow score (Broberg and Morrey), MEPS and QuickDASH score.  Secondary outcomes included visual analog scale (VAS), ROM, operation time and complications.  The "assessing risk of bias" table was applied to assess the risk of bias of the included studies.  A total of 8 studies were included in this meta-analysis, which consisted of 138 cases of ORIF and 181 RHA.  Methodological quality of the studies was moderate-to-low; RHA afforded significantly higher satisfaction rate, better elbow score (Broberg and Morrey) and MEPS, shorter operation time, lower incidence of bone nonunion or absorption and internal fixation failure when compared to ORIF.  There were no significantly differences in QuickDASH score and other complications.  The authors concluded that RHA had better outcome in patients with radial head fractures (modified Mason type III and IV) than ORIF with medium-short-term follow-up period, but longer-term studies are needed to examine if the apparent benefits of RHA were offset by late complications.

Osteoarthritis Secondary to Fracture

Celli (2016) stated that during the past decade, TEA procedures have increased because of an increase in the number of trauma patients. Even though most current posterior approaches to the elbow provide excellent joint exposure, they involve the risk of extensor mechanism injury and of eventual insufficiency, particularly in patients with osteoarthritis (OA) secondary to fracture.  The author described a new triceps exposure approach for TEA, the anconeus-triceps lateral flap, which has proved valuable in patients with distal humeral and olecranon fracture malunion, and its preliminary results at a minimum follow-up of 24 months.  A total of 20 consecutive patients with OA due to distal humeral and olecranon fracture malunion underwent TEA by the anconeus-triceps lateral flap approach, which preserves the olecranon insertion of the medial portion of the triceps proper tendon.  At a mean follow-up of 33 months, the mean MEPI rose from 41.3 to 94.3.  The mean pain score on the VAS fell from 7.1 to 1.1.  There were no patients with insufficiency, secondary detachment of the triceps tendon, or grade 4 to 5 of the Medical Research Council (MRC) scale.  The author concluded that these preliminary data suggested that preservation of the insertion of the medial portion of the triceps proper tendon enabled earlier active rehabilitation.  Moreover, the new approach provided optimum exposure of the olecranon also in patients with OA secondary to intra-articular fracture of the distal humerus and olecranon, where scarring and bone deformity usually hamper joint exposure.

Cementless Total Elbow Arthroplasty (Discovery Elbow System)

Giannicola and colleagues (2014) prospectively evaluated preliminary results of the Discovery Elbow System (DES) used for acute distal humerus fractures and post-traumatic conditions.  These researchers analyzed 24 patients (9 men and 15 women), with a mean age of 69 years (range of 45 to 89); 10 had comminuted distal humerus fractures (group I), and 14 had severe post-traumatic arthritis, chronic instability, or nonunion (group II).  Clinical and radiographic evaluations were performed.  The pre-operative (group II) and post-operative (both groups) evaluations were assessed with the MEPS and MEPI, the Quick DASH score, and the modified American Shoulder and Elbow Surgeons score.  Patient satisfaction was evaluated on a 4-point scale.  Mean follow-up was 41 months (range of 29 to 63).  At the last evaluation, average flexion, extension, pronation, and supination were 136°, 17°, 80°, and 83°, respectively.  The average MEPS, QuickDASH score, and the modified American Shoulder and Elbow Surgeons score were 96, 20, and 84, respectively, and without significant inter-group differences.  According to the MEPI, there were 20 excellent, 3 good, and 1 fair result; 20 patients were very satisfied or satisfied with the outcome.  A significant increase in the functional scores was observed in group II compared with pre-operative results.  Radiological evaluation showed 1 patient with progressive radiolucency and 1 with a non-progressive radiolucency at the final follow-up.  No mechanical failures were observed; 2 transient ulnar neuropathies, 1 wound infection, and 1 epicondyle fracture were observed.  The authors concluded that the DES yielded promising 2- to 5-year results in the treatment of acute fractures and post-traumatic conditions regarding pain relief, functional improvement, and patient satisfaction, achieving excellent results in most cases.  They stated that the DES may represent an effective linked-implant option for total elbow replacement in such patients; however, long-term studies are needed.

Frostick and associates (2017) noted that available literature on the use of a cementless TEA design and its results are limited.  These researchers reported the outcome of the cementless DES.  Patients were operated on by a single surgeon between 2007 and 2014.  A total of 19 patients (20 elbows) were available for review, 2 women (1 bilateral TEA) and 17 men.  The age of the patients ranged from 27 to 75 years (mean of 48).  The mean follow-up was 61.8 months (range of 12 to 156).  Patients were assessed for ROM, pain, and satisfaction level.  Outcome scores included the MEPS, the Liverpool Elbow Score, and the 12-Item Short Form Health Survey (version 1).  Radiographs were reviewed to evaluate for loosening.  The mean MEPS was 77.25, and the mean Liverpool Elbow Score was 6.76.  The mean flexion range was 123°, and the mean extension lag was 35°.  The mean pronation was 59°, and the mean supination was 58°.  On radiologic evaluation, there were no signs of loosening; however, in 2 cases, non-progressive radiolucent lines were observed.  No signs of infection were detected at final follow-up, and no elbows were revised.  More than 90 % of patients were satisfied with the overall outcome.  The authors concluded that the cementless TEA appeared to be a reliable option for treatment of varying elbow diseases; however, long-term results are needed to assess the survivorship of this design.

Hanninen and co-workers (2017) stated that DES is a semi-constrained prosthesis, mainly used for patients with rheumatoid arthritis (RA).  Records from 79 patients with RA (90 DES arthroplasties) were reviewed; 47 patients with 55 DES elbows were re-examined; ROM of both elbows, upper limb function, and quality of life (DASH score, MEPS, and the RAND 36-Item Health Survey [RAND-36]) were assessed.  Cementing quality was assessed, and radiolucent lines measured from plain radiographs.  Mean follow-up was 64) months (range of 24 to 123).  Pre-operatively to post-operatively, mean elbow flexion improved from 120°to 146°(p < 0.001) and mean extension lag improved from 29°to 24°(p = 0.02), respectively.  At follow-up, mean supination was 66°, mean pronation was 69°, and mean grip strength was 14 kg.  Grip strength and ROM (except supination) were similar between the DES elbow and contralateral un-operated elbow.  Mean post-operative MEPS was 93 points (excellent, n = 38; good, n = 14; fair, n = 2; and poor, n = 1).  Mean DASH score was 43 points.  The RAND-36 showed that physical functioning, physical role functioning, bodily pain, and general health were lower than the Finnish reference values.  Primary cementing was challenging, and radiolucent lines appeared during follow-up; 4 prostheses were revised because of aseptic loosening (n = 3) and peri-prosthetic fracture (n = 1).  The authors concluded that DES provided significant improvement in patient's flexion-extension arc.  They stated that cementing of the elbow prosthesis was challenging; radiolucent lines appeared during the 5-year follow-up, but their clinical relevance remains unclear.  Moreover, first-generation locking screws may loosen over time. Level of evidence = IV.

Treatment of Distal Humerus Fractures

In a prospective, randomized, controlled trial (RCT), McKee and associates (2009) compared functional outcomes, complications, and re-operation rates in elderly patients with displaced intra-articular, distal humeral fractures treated with ORIF or primary semi-constrained TEA.  A total of 42 patients were randomized by sealed envelope.  Inclusion criteria were age greater than 65 years; displaced, comminuted, intra-articular fractures of the distal humerus (Orthopaedic Trauma Association type 13C); and closed or Gustilo grade I open fractures treated within 12 hours of injury.  Both ORIF and TEA were performed following a standardized protocol.  The MEPS and DASH score were determined at 6 weeks, 3 months, 6 months, 12 months, and 2 years.  Complication type, duration, management, and treatment requiring re-operation were recorded.  An intention-to-treat (ITT) analysis and an on-treatment analysis were conducted to address patients randomized to ORIF but converted to TEA intra-operatively; 21 patients were randomized to each treatment group; 2 died before follow-up and were excluded from the study; 5 patients randomized to ORIF were converted to TEA intra-operatively because of extensive comminution and inability to obtain fixation stable enough to allow early range of motion. This resulted in 15 patients (3 men and 12 women) with a mean age of 77 years in the ORIF group and 25 patients (2 men and 23 women) with a mean age of 78 years in the TEA group.  Baseline demographics for mechanism, classification, co-morbidities, fracture type, activity level, and ipsilateral injuries were similar between the 2 groups.  Operative time averaged 32 minutes less in the TEA group (p = 0.001).  Patients who underwent TEA had significantly better MEPSs at 3 months (83 versus 65, p = 0.01), 6 months (86 versus 68, p =0 .003), 12 months (88 versus 72, p = 0.007), and 2 years (86 versus 73, p = 0.015) compared with the ORIF group.  Patients who underwent TEA had significantly better DASH scores at 6 weeks (43 versus 77, p = 0.02) and 6 months (31 versus 50, p = 0.01); but not at 12 months (32 versus 47, p = 0.1) or 2 years (34 versus 38, p = 0.6).  The mean flexion-extension arc was 107 degrees (range of 42 degrees to 145 degrees) in the TEA group and 95 degrees (range of 30 degrees to140 degrees) in the ORIF group (p = 0.19).  Re-operation rates for TEA (3/25 [12 %]) and ORIF (4/15 [27 %]) were not statistically different (p = 0.2).  TEA for the treatment of comminuted intra-articular distal humeral fractures resulted in more predictable and improved 2-year functional outcomes compared with ORIF, based on the MEPS; DASH scores were better in the TEA group in the short-term; but were not statistically different at 2 years' follow-up.  TEA may result in decreased re-operation rates, considering that 25 % of fractures randomized to ORIF were not amenable to internal fixation.  The authors concluded that TEA is a preferred alternative for ORIF in elderly patients with complex distal humeral fractures that are not amenable to stable fixation; elderly patients have an increased baseline DASH score and appeared to accommodate to objective limitations in function with time.

Egol and colleagues (2011) stated that treating intra-articular fractures about the osteoporotic distal humerus poses a significant challenge.  In a retrospective study, these researchers evaluated functional outcomes for distal humeral fractures treated with TEA or ORIF in a non-arthritic elderly population with osteoporosis.  They reviewed the records of all women older than 60 years who had undergone surgical treatment for intra-articular distal humerus fractures (Orthopaedic Trauma Association types 13B and 13C) by 1 of 2 surgeons.  Demographic and operative data were obtained, charts were reviewed, and patients were asked to have their outcomes evaluated with the DASH questionnaire and the MEPI.  A total of 22 patients (23 elbows) were identified, and 2 of these (3 elbows) were excluded.  Of the remaining 20 patients, 9 had undergone cemented, semi-constrained TEA as initial treatment, and 11 had undergone ORIF.  These 2 groups were compared.  Mean follow-up was 14.8 months (range of 6 to 38 months).  There were no significant differences between the TEA and ORIF groups with respect to demographic factors.  Final elbow ROM was 92° flexion-extension arc (arthroplasty group) and 98° (fixation group); 2 patients in the arthroplasty group and 2 in the fixation group died.  For the remaining patients, mean DASH scores were 30.2 (arthroplasty) and 32.1 (fixation), and mean MEPI scores were 79 (arthroplasty) and 85 (fixation).  These differences were not statistically significant; 4 TEAs developed radiographic loosening by a mean of 15 months, and 1 of these underwent revision with good outcome; 10 of the 11 fractures in the fixation group healed radiographically; the 1 nonunion with collapse continued to be asymptomatic; 2 patients in the fixation group underwent contracture release after union for limited elbow ROM.  The authors concluded that many factors come into play in the treatment of intra-articular distal humerus fractures in patients with osteoporosis; implant selection must be based on bone quality, expected outcome, and surgeon experience.  They noted that for these injuries, good outcomes may be obtained with either ORIF or TEA.

In a systematic review and meta-analysis, Githens and co-workers (2014) analyzed outcomes and complication rates in elderly patients with intra-articular distal humerus fractures being treated with either TEA or ORIF with locking plates.  PubMed, Embase, and the Cochrane databases were used.  The search included publications up to June 2013.  Article selection was independently performed by 2 authors and disagreements were resolved by consensus.  Studies meeting criteria for inclusion were observational cohort studies or RCTs evaluating functional and radiographic outcomes and complications in elderly patients treated for distal humerus fractures with either primary TEA or ORIF with locking plates.  Studies with mean age of less than 60 years, indications for TEA other than acute fracture, and those including non-locked plates were excluded.  Standardized data extraction was performed.  A quality assessment tool was used to evaluate individual study methodology.  Descriptive statistics for functional outcomes were reported.  Meta-analysis and regression analysis were performed for complication rates.  The authors concluded that the findings of this systematic review and meta-analysis revealed that TEA and ORIF for the treatment of geriatric distal humerus fractures produced similar functional outcome scores and ROM.  Although there was a trend toward a higher rate of major complications and re-operation after ORIF, this was not statistically significant.  The quality of study methodology was generally weak.  Ongoing research including prospective trials and cost analysis is indicated to better define the roles of ORIF versus TEA in the management of these injuries.

Linn and colleagues (2014) stated that TEA is a viable treatment for elderly patients with distal humerus fracture who frequently present with low-grade open fractures.  These investigators evaluated the results of a protocol of serial irrigations and debridements (I&Ds) followed by primary TEA for the treatment of open intra-articular distal humerus fractures.  A total of 7 patients (mean age of 74 years; range of 56 to 86 years) with open (2 Grade-I and 5 Grade-2) distal humerus fractures (OTA 13C) who were treated between 2001 and 2007 with a standard staged protocol that included TEA were studied.  Baseline DASH scores were obtained during the initial hospitalization, and the 6- and 12-month follow-up visits.  Elbow ROM measurements were obtained at each follow-up visit.  Follow-up averaged 43 (range of 4 to 138) months.  There were no wound complications and no deep infections.  Complications included 1 case of heterotopic ossification with joint contracture, 1 olecranon fracture unrelated to the TEA, and 2 loose humeral stems.  The average final ROM was from 21° (range of 5 to 30°) to 113° flexion (range of 90 to 130°); DASH scores averaged 25 at pre-injury baseline and 48 at the most recent follow-up visits.  The authors concluded that TEA had become a mainstream option for the treatment of distal humerus fractures which are on occasion open.  There was hesitation in using arthroplasty in an open fracture setting due to a potential increased infection risk.  The absence of any infectious complications and satisfactory functional outcomes observed in the current series indicated that TEA is a viable treatment modality for complex open fractures of the distal humerus.

Harmer and Sanchez-Sotelo (2015) noted that TEA is a good treatment alternative for selected patients with distal humerus fractures.  Its attractiveness is related to several factors, including the possibility of performing the procedure; leaving the extensor mechanism intact; faster, easier rehabilitation compared with internal fixation; and overall good outcomes reported in terms of both pain relief and function.  Implant failure leading to revision surgery does happen, and patients must comply with certain limitations to extend the longevity of their implant.  These investigators stated that development of high-performance implants may allow expanding the indications of elbow arthroplasty for fractures.

Lovy and associates (2016) evaluated 30-day post-operative complications of ORIF and TEA for the treatment of distal humerus fractures in elderly patients using a validated national database.  Review of the National Surgical Quality Improvement Program (NSQIP) Database identified all elderly patients (greater than 65 years of age) who underwent TEA or ORIF for the treatment of closed intra-articular distal humerus fractures from 2007 to 2013.  Bi-variate and multi-variate analyses of risk factors for 30-day adverse events (AEs) as defined by NSQIP between ORIF and TEA groups were assessed using pre-operative and intra-operative variables.  Among the 176 patients with distal humerus fractures, there were 33 TEA and 143 ORIF.  There was no difference in age, medical co-morbidities, or functional status; TEA was associated with an increased odds of severe AEs compared to ORIF (odds ratio [OR] = 1.57, p = 0.16), although it did not achieve statistical significance.  Infection rate was 0.7 % in ORIF and 0.0 % in TEA (p = 0.99).  Insulin-dependent diabetes and functional status were significant independent predictors of post-operative AEs.  Operative time (165 minutes versus 140 minutes, p = 0.06) and post-operative length of stay (LOS; 3.6 days versus 2.3 days, p = 0.03) were longer for TEA compared to ORIF.  The authors concluded that ORIF and TEA had similar 30-day post-operative complications for the treatment of distal humerus fractures among elderly patients.  They stated that despite favorable trends for TEA in recent studies, additional clinical results are needed to understand complications and limitation of TEA.

Rajaee and co-workers (2016) stated that displaced intra-articular distal humeral fractures are a challenging injury in elderly patients.  High rates of complications have led to the increasing use of TEA for primary treatment.  These investigators presented US nationwide trends in primary TEA for distal humeral fractures in elderly patients (65 years and older) from 2002 to 2012.  They hypothesized that there was an increase in the rate of TEA utilization.  Data were obtained from the Nationwide Inpatient Sample for the years 2002 to 2012.  All inpatients 65 years and older with distal humeral fractures were identified and were divided into 2 subgroups based on the operation they received: TEA or ORIF.  Between 2002 and 2012, the annual frequency of TEA for elderly patients with distal humeral fractures increased 2.6-fold, with 147 patients in 2002 and 385 in 2012.  In 2012, TEA was performed in 13 % of operatively treated distal humeral fractures compared with only 5.1 % in 2002 (p < 0.05).  Mean hospital charges increased significantly for both the ORIF and TEA groups from 2002 to 2012.  The average hospital charge for TEA in 2012 was $85,365, which was $16,358 higher than that for patients who underwent ORIF (p < 0.05).  The authors concluded that the national rate of primary TEA for the acute management of distal humeral fractures in elderly patients has increased significantly over the past 10 years.  They stated that given the significant complexity, long-term restrictions, and risks associated with TEA, this increasing trend should be analyzed closely.

Prasad and associates (2016) reviewed their experience of Coonrad-Morrey TEA for fractures of the distal humerus in non-rheumatoid patients with a minimum of 10 years follow-up.  TEA through a triceps splitting approach was performed in 37 non-rheumatoid patients for a fracture of the distal humerus between 1996 and 2004; 1 patient could not be traced and 17 had died before the 10th anniversary of their surgery.  This left 19 patients with a minimum follow-up of 10 years to form the study group.  Of these, 13 patients were alive at the time of final review.  The other 6 had died, but after the 10th anniversary of their elbow arthroplasty.  Their clinical and radiological data were included in the study.  The mean follow-up of the 19 patients was 156 months (120 to 210); 2 patients in the study group had undergone revision; another patient had undergone a 2-stage revision for infection but died before 10-year follow-up; 6 other patients in the study group had evidence of loosening or wear of their bushings; 2 were clinically symptomatic and were offered revision surgery.  Male patients showed higher incidence of loosening and wear.  Survivorship, with revision and definite loosening as end-points, was 89.5 % at 10 years in those patients followed for a minimum of 10 years and 86 % in the whole group of 36 patients.  The authors concluded that the findings of this study showed that only 53 % of non-rheumatoid patients who undergo TEA for a fracture of the distal humerus survived to the 10th anniversary of their index procedure.  For those who survived, TEA provided acceptable outcomes in terms of function and implant survival.

Barco and co-workers (2017) noted that TEA is commonly considered for elderly patients with comminuted distal humeral fractures.  Satisfactory short-term outcomes have been reported, but long-term outcomes are unknown.  These researchers evaluated the long-term outcomes of TEA after distal humeral fracture and determined differences between elbows with or without inflammatory arthritis at the time of fracture.  A total of 44 TEA were performed after distal humeral fracture; those patients were followed for a minimum of 10 years and were evaluated with regard to pain, motion, MEPS, complications, and re-operations.  The outcomes in elbows with and without inflammatory arthritis were compared.  Kaplan-Meier survivorship analysis was performed.  Total elbow arthroplasty provided good pain relief and motion; the mean VAS for pain was 0.6, the mean flexion was 123°, and the mean loss of extension was 24°.  The mean MEPS was 90.5 points, with 3 patients scoring less than 75 points; 5 elbows (11 %) developed deep infection, treated surgically with component retention (3 acute) or resection (2 chronic).  Implant revision or resection was performed in 8 elbows (18 %): 3 for infections (1 re-implantation and 2 resections), 3 for ulnar loosening (associated with peri-prosthetic fracture in 1), and 2 for ulnar component fractures.  Additional peri-prosthetic fractures were observed in 5 elbows.  The survival rates for elbows with rheumatoid arthritis were 85 % at 5 years and 76 % at 10 years, and the survival rates for elbows without rheumatoid arthritis were 92 % at both 5 and 10 years.  The most relevant risk factor for revision was male sex (hazard ratio [HR], 12.6 [95 % confidence interval [CI]: 1.7 to 93.6]).  The authors concluded that selective use of TEA to treat fractures of the distal part of the humerus for infirm, less active older patients and patients with inflammatory arthritis had acceptable longevity in surviving patients, but at the cost of a number of major complications.

Schoch and colleagues (2017) stated that TEA is a therapeutic option for end-stage arthritis in low-demand patients willing to accept the limitations of TEA.  Concern remains regarding the longevity of TEA implants, especially in younger patients.  These researchers determined the failure rate and complication profile of TEA performed in patients aged less than 50 years.  Between 2009 and 2013, 11 linked TEAs were performed in patients aged less than 50 years (mean age of 37 years; range of 22 to 47 years).  Outcome measures included pain; ROM; DASH scores; MEPS; complications; and re-operations.  Elbows were observed for a minimum of 2 years or until mechanical failure.  Mean follow-up was 3.2 years.  At follow-up, 82 % of TEAs had experienced a complication; 6 elbows sustained mechanical failures (5 had ulnar loosening and 1 had humeral loosening).  Pain improved from 8.0 to 4.9; extension improved from 34° to 22°and flexion increased from 113°to 128°.  Mean DASH score for surviving implants at follow-up was 42.9 (range of 17.5 to 56.7); MEPS for surviving implants were rated as excellent (n = 2), good (n = 1), and fair (n = 2).  The authors concluded that high rates of early mechanical failure, predominately ulnar loosening, were observed in TEA in patients aged less than 50 years.  They stated that surgeons should remain cautious in performing TEA in young patients who can be expected to use the TEA in a more demanding fashion, placing them at higher risk for mechanical failure.

Ginesin and colleagues (2017) stated that intra-articular elbow fractures are considered to be one of the most complex injuries in orthopedic trauma.  Some are too comminuted for ORIF.  Recently, TEA has gained popularity for the treatment of comminuted elbow trauma when other therapeutic options are not possible.  From 2007 to 2013, these investigators treated 18 patients with TEA due to comminuted distal humeral fractures.  They used the DASH score to evaluate the patient's satisfaction.  In addition, they evaluated the elbow ROM and collateral stability.  The authors concluded that functional ROM was achieved with high patient satisfaction.  The authors concluded that TEA is a reasonable option for complex elbow fractures when ORIF is not suitable.

Krukhaug and associates (2018) presented the long-term survivorship (20 years) of TEA for a relatively large population and compared different prosthesis brands and patient sub-groups.  Between 1994 and 2017, a total of 838 primary TEAs were reported to the Norwegian Arthroplasty Register.  Implant survival was calculated using the Kaplan-Meier method; risk differences were examined using Cox regression analyses and exact Cox regression for rare events.  These investigators compared the survivorship of the 8 most frequently used implant brands, the different diagnoses (including fractures) leading to TEA, and the influence of the fixation technique.  The overall 5-, 10-, 15-, and 20-year survival rates for all elbow arthroplasties were 92 %, 81 %, 71 %, and 61 %, respectively; risk factors for revision were a diagnosis of sequelae after trauma and cementless fixation of the ulna component.  There were some differences between the implant brands; the Norway prostheses had higher survival compared with the Kudo after 15 years of follow-up (78 % and 66 %, respectively; p < 0.001).  Among the implants with shorter follow-up, the IBP and NES had inferior survivorship compared with the Norway.  The frequently used Discovery had promising survivorship up to 5 years.  The most frequent reason for revision surgery was aseptic loosening, followed by defective polyethylene, infection, and dislocation.  The revision causes were to some degree implant-specific.  The authors concluded that fairly good results in terms of prosthesis survival were obtained with TEA, although results were poorer than those for knee and hip arthroplasties.

Goodman and colleagues (2018) noted that distal humerus fractures are challenging to treat, with significant morbidity.  Pre-contoured distal humerus locking plates and TEA implants have become available in the past 15 years, potentially offering the promise of improved outcomes.  However, national data regarding the usage of and in-hospital complications associated with these implants is scarce.  These investigators examined if the incidence of inpatients with distal humerus fractures treated with TEA or ORIF changed over time.  Secondarily, they determined what demographic factors were associated with arthroplasty versus fixation and compared inpatient outcomes.  Inpatients over 50 years old with operatively treated closed distal humerus fractures were identified between 2002 and 2014 in the Nationwide Inpatient Sample, a nationally representative, all-payer database.  Patient demographic factors were associated with treatment type.  Outcomes examined included complications, mortality, LOS, and charges; multi-variable logistic regression compared associations with treatment.  Of 56,379 inpatients undergoing surgery, the proportion undergoing arthroplasty rose 2.3-fold from 4.8 % to 10.9 % from 2002 to 2014 (OR = 1.039/year; 95 % CI: 1.016 to 1.062).  Annual patient volume remained similar. Arthroplasty patients were older than those undergoing fixation (75.5 versus 71.0 years, p < 0.001), more likely to be female (83.1 % versus 75.4 %, p < 0.001), and less likely to be treated at a rural hospital (OR = 0.601, 95 % CI: 0.445 to 0.812, p < 0.001).  There was no significant difference in co-morbidities.  Arthroplasty patients had similar inpatient medical complication (7.1 % versus 7.8 %, OR 0.998, p = 0.988) and mortality rates (0.38 % versus 0.94 %, OR = 0.426, p = 0.102), a decreased LOS (by 0.3 days, p = 0.032), but increased hospital charges (by $12,033, p < 0.001).  The authors concluded that for inpatients over 50 years old with operatively-treated distal humerus fractures, use of TEA has expanded, albeit with increased cost.  They stated that further studies may help to delineate the long-term costs and benefits, as well as which patients may benefit from each type of implant.

Revision Total Elbow Arthroplasty

In a retrospective study that used 5 % Medicare Part B claims data-base, Goyal and co-workers (2020) compared re-operation risk after TEA and ORIF for intra-articular distal humerus fractures in elderly patients.  Subject were patients older than 65 years of age with closed distal humerus fractures undergoing TEA or ORIF from 1996 to 2016.  Main outcome measure was re-operation risk based on multi-variate Cox proportional hazards modeling.  A total of 142 TEA and 522 ORIF cases were identified.  TEA patients were older and had a higher Charlson Comorbidity Index, as well as a higher prevalence of RA and osteoporosis than ORIF patients (p < 0.05).  Although re-operation risk was lower for TEA than that for ORIF within the entire cohort (11.3 % versus 25.1 %; HR = 0.49; p = 0.014), no significant difference was found for TEA and ORIF performed between 2006 and 2016 (12.6 % versus 18.4 %; HR = 0.73; p = 0.380).  The death rate was 65.5 % in the TEA group at 3.6 years and 55.7 % in the ORIF group at 4.9 years.  The authors concluded that TEA was associated with a decreased re-operation risk compared with ORIF, although this difference did not exist for more recent procedures after popularization of the locking plate technology and 50 % of the re-operations after ORIF were for instrumentation removal.  The high death rate within several years of the index procedure may contribute to the low TEA revision rate beyond the short-term when following patients into the medium- and long-term.  These researchers stated that further study comparing TEA and locked plating using prospective, randomized data with long-term follow-up and functional outcomes is needed.  Level of evidence: Therapeutic Level III.

Bellevue and colleagues (2020) noted that TEA has a higher rate of revision and complications than other total joint arthroplasties.  Salvage options for failed TEAs are limited, especially when patients have poor ulnar bone stock.  These researchers described a surgical technique and reported outcomes of patients who underwent revision TEA with implantation of the ulnar component into the radius to address ulna bony defects.  This study was a retrospective review of 5 patients at a single institution from 2014 to 2019 in which the ulnar component was implanted into the radius to address large bony defects in the setting of revision TEA.  At follow-up of 2.1 ± 1.9 years, patients experienced an increase in total arc of motion from 86 ± 17° to 112 ± 8°, with infection eradication and no instances of distal component loosening.  The authors concluded that this salvage technique was effective at providing a stable elbow in patients with large ulnar defects as a result of prosthetic joint infection (PJI) or peri-prosthetic fracture.  This was a small (n = 5), single-center study with medium-term follow-up (2.1 years); these findings need to be validated by well-designed studies with a larger cohort and longer follow-up duration.

Burnier and associates (2020) stated that when revision elbow arthroplasty is needed in the presence of structural proximal ulnar bone loss and triceps insufficiency, structural ulnar bone-grafting and triceps reconstruction are both needed to reconstruct the skeleton and to restore active extension.  These researchers developed a technique utilizing a structural proximal ulnar allograft with its attached triceps as an allograft-prosthetic composite (APC) to provide reconstruction of the proximal ulnar bone and deficient extensor mechanism with the same allograft.  Between 2010 and 2017, the senior author performed 10 revision elbow arthroplasties using a proximal ulnar allograft with its intact triceps tendon allograft.  The allograft ulna was combined with an ulnar component in an APC fashion, whereas the remaining triceps was repaired to the triceps allograft.  Indications for a revision surgical procedure included aseptic loosening in 4 elbows, peri-prosthetic ulnar fracture with component loosening in 2 elbows, and the second stage of a 2-stage re-implantation in 4 elbows; 2 elbows also needed humeral APCs due to associated structural humeral bone loss.  Post-operatively, all elbows were immobilized in extension for 6 weeks.  The mean follow-up time was 45 months (range of 24 to 76 months).  Revision elbow arthroplasty resulted in pain improvement in all elbows in a 10-point VAS.  The mean flexion-extension arc was 95°, the mean MEPS was 76 points (range of 45 to 95 points), and the mean triceps strength score was 4.  There were 6 re-operations: 3 for humeral loosening, 1 for deep infection, 1 for fracture of the ulnar allograft, and 1 for wound debridement and closure.  For the 8 elbows with an intact ulnar reconstruction, no ulnar components were radiographically loose, and the ulnar graft was considered radiographically intact and healed in 8 elbows.  The authors concluded that reconstruction of the proximal part of the ulna and triceps in failed elbow arthroplasties with structural ulnar bone loss could be effectively accomplished using a structural proximal ulnar allograft as an APC with the preserved triceps tendon for the extensor mechanism reconstruction, however, the procedure was associated with an expected high re-operation rate, as was the case in complex revision elbow arthroplasty.  Level of evidence = IV.

Total Elbow Arthroplasty in Patients with Rheumatoid Arthritis

Chou and colleagues (2020) examined the outcome of TEA in patients with RA, and identified factors that affect the outcome.  These investigators searched PubMed, Medline, Cochrane Reviews, and Embase from January 2003 to March 2019.  The primary objective was to determine the implant failure rate, the mode of failure, and risk factors predisposing to failure.  A secondary objective was to identify the overall complication rate, associated risk factors, and clinical performance.  A meta-regression analysis was completed to identify the association between each parameter with the outcome.  A total of 38 studies including 2,118 TEAs were included in the study . The mean follow-up was 80.9 months (8.2 to 156).  The implant failure and complication rates were 16.1 % (95 % CI: 0.128 to 0.200) and 24.5 % (95 % CI: 0.203 to 0.293), respectively.  Aseptic loosening was the most common mode of failure (9.5 %; 95 % CI: 0.071 to 0.124).  The mean post-operative ROMs were: flexion 131.5° (124.2° to 138.8°), extension 29.3° (26.8° to 31.9°), pronation 74.0° (67.8° to 80.2°), and supination 72.5° (69.5° to 75.5°), and the mean post-operative MEPS was 89.3 (95 % CI: 86.9 to 91.6).  The meta-regression analysis identified that younger patients and implants with an unlinked design correlated with higher failure rates.  Younger patients were associated with increased complications, while female patients and an unlinked prosthesis were associated with aseptic loosening.  The authors concluded that TEA continued to provide satisfactory results for patients with RA.  However, it was associated with a substantially higher implant failure and complication rates compared with hip and knee arthroplasties.  The patient's age, sex, and whether cemented fixation and unlinked prosthesis were used could influence the outcome.  Level of Evidence = IV.

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 covered if selection criteria are met:
24360	Arthroplasty, elbow; with membrane (eg, fascial)
24361	with distal humeral prosthetic replacement
24362	with implant and fascia lata ligament reconstruction
24363	with distal humerus and proximal ulnar prosthetic replacement (eg, total elbow)
24365	Arthroplasty, radial head
24366	with implant
24370	Revision of total elbow arthroplasty, including allograft when performed; humeral or ulnar component
24371	humeral and ulnar component
ICD-10 codes covered if selection criteria are met:
M00.021 - M00.029 M00.121 - M00.129 M00.221 - M00.229 M00.821 - M00.829 M00.9	Pyogenic [septic] arthritis [elbow]
M24.621 - M24.629	Ankylosis, elbow
M25.321 - M25.329	Other instability, elbow
M25.521 - M25.529	Pain in elbow
S42.431A -S42.433S	Fracture (avulsion) of lateral epicondyle of humerus
S42.441A - S42.443S	Fracture (avulsion) of medial epicondyle of humerus
S42.451A - S42.453S	Fracture of lateral condyle of humerus
S42.461A - S42.463S	Fracture of medial condyle of humerus
S42.471A - S42.473S	Transcondylar fracture of humerus
S52.121+ - S52.126+	Fracture of head of radius
T84.410+ - T84.498+	Mechanical complication of other internal orthopedic devices, implants and grafts, initial encounter [elbow]
T84.50x+, T84.559+	Infection and inflammatory reaction due to internal joint prosthesis [elbow]
ICD-10 codes not covered for indications listed in the CPB:
M19.221 - M19.229	Secondary osteoarthritis [secondary to fracture]
S42.401+ – S42.496+, S42.434A – S42.436S, S42.444A - S42.499S, S42.454A = S42.456S, S42.464A – S42.466S, S42.474A - S42.496+, S49.101+ - S49.199+	Fracture of lower end of humerus

The above policy is based on the following references: