Close

Elbow Arthroplasty

Number: 0857



Policy

Aetna considers total elbow arthroplasty medically necessary 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.

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 elbow hemiarthoplasty experimental and investigational for the treatment of humerus fractures because the effectiveness of this approach has not been established.

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 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 Mayo Elbow Performance Score, 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; Mayo Elbow Performance Index; 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 Mayo Elbow Performance Score (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 Mayo Elbow Performance Score and Mayo Elbow Performance Index, 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 Mayo Elbow Performance Score, 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 Mayo Elbow Performance Index, 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 Mayo Elbow Performance Score, 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.

CPT Codes / HCPCS Codes / ICD-9 Codes
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
ICD-10 codes will become effective as of October 1, 2015:
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
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:
S42.401+ – S42.496+, S49.101+ - S49.199+ Fracture of lower end of humerus


The above policy is based on the following references:
    1. Bain GI, et al. Management of Mason type-III radial head fractures with a titanium prosthesis, ligament repair, and early mobilization. Surgical technique. J Bone Joint Surg Am. 2005;87.Suppl 1(Pt 1):136-47..
    2. Calfee R, et al. Radial head arthroplasty. J Hand Surg [Am]. 2006;31(2):314-321.
    3. Chapman CB, et al. Vitallium radial head prosthesis for acute and chronic elbow fractures and fracture-dislocations involving the radial head. J Shoulder Elbow Surg. 2006;15(4):463-473.
    4. Doornberg JN, et al. Radial head arthroplasty with a modular metal spacer to treat acute traumatic elbow instability. J Bone Joint Surg Am. 2007;89:1075-1080.
    5. Grewal R, et al. Comminuted radial head fractures treated with a modular metallic radial head arthroplasty. Study of outcomes. J Bone Joint Surg Am. 2006;88:2192-2200.
    6. Harrington IJ, et al. The functional outcome with metallic radial head implants in the treatment of unstable elbow fractures: A long-term review. J Trauma. 2001;50(1):46-52.
    7. King GJ. Management of comminuted radial head fractures with replacement arthroplasty. Hand Clin. 2004;20(4):429-441.
    8. Kuntz DG, Baratz ME. Fractures of the elbow. Orthop Clin North Am. 1999;30(1):37-61.
    9. Martinelli B. Silicone-implant replacement arthroplasty in fractures of the radial head. A follow-up report. Bull Hosp Jt Dis Orthop Inst. 1985;45(2):158-161.
    10. Moro JK, et al. Arthroplasty with a metal radial head for unreconstructible fractures of the radial head. J Bone Joint Surg Am. 2001;83-A(8):1201-1211.
    11. Rizzo M, Nunley JA. Fractures of the elbow’s lateral column radial head and capitellum. Hand Clin. 2002;18(1):21-42.
    12. Rosenblatt Y, Athwal GS, Faber KJ. Current recommendations for the treatment of radial head fractures. Orthop Clin North Am. 2008;39(2):173-185.
    13. Swanson AB, et al. Comminuted fractures of the radial head. The role of silicone-implant replacement arthroplasty. J Bone Joint Surg Am. 1981;63(7):1039-1049.
    14. Burkhart KJ, Nijs S, Mattyasovszky SG, et al. Distal humerus hemiarthroplasty of the elbow for comminuted distal humeral fractures in the elderly patient. J Trauma. 2011;71(3):635-642.
    15. Verbeek PA, van den Akker-Scheek I, Wendt KW, Diercks RL. Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: Design of a randomized controlled trial. BMC Musculoskelet Disord. 2012;13:16.
    16. Argintar E, Berry M, Narvy SJ, et al.  Hemiarthroplasty for the treatment of distal humerus fractures: Short-term clinical results. Orthopedics. 2012;35(12):1042-1045.
    17. Wang Y, Zhuo Q, Tang P, Yang W. Surgical interventions for treating distal humeral fractures in adults. Cochrane Database Syst Rev. 2013;1:CD009890.
    18. Githens M, Yao J, Sox AH, Bishop J. Open reduction and internal fixation versus total elbow arthroplasty for the treatment of geriatric distal humerus fractures: A systematic review and meta-analysis. J Orthop Trauma. 2014;28(8):481-488.
    19. Hohman DW, Nodzo SR, Qvick LM, et al. Hemiarthroplasty of the distal humerus for acute and chronic complex intra-articular injuries. J Shoulder Elbow Surg. 2014;23(2):265-272.
    20. Sebastia-Forcada E, Cebrian-Gomez R, Lizaur-Utrilla A, Gil-Guillen V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014;23(10):1419-1426.
    21. Linn MS, Gardner MJ, McAndrew CM, et al. Is primary total elbow arthroplasty safe for the treatment of open intra-articular distal humerus fractures? Injury. 2014;45(11):1747-1751.
    22. Mansat P, Bonnevialle N, Rongieres M, et al. The role of total elbow arthroplasty in traumatology. Orthop Traumatol Surg Res. 2014;100(6 Suppl):S293-S298.
    23. Giannicola G, Scacchi M, Polimanti D, Cinotti G. Discovery elbow system: 2- to 5-year results in distal humerus fractures and posttraumatic conditions: A prospective study on 24 patients. J Hand Surg Am. 2014;39(9):1746-1756
    24. Alizadehkhaiyat O, Al Mandhari A, Sinopidis C, et al. Total elbow arthroplasty: A prospective clinical outcome study of Discovery Elbow System with a 4-year mean follow-up. J Shoulder Elbow Surg. 2015;24(1):52-59
    25. Heijink A, Wagener ML, de Vos MJ, Eygendaal D. Distal humerus prosthetic hemiarthroplasty: Midterm results. Strategies Trauma Limb Reconstr. 2015 Aug 27 [Epub ahead of print]
    26. Ogino H, Ito H, Furu M, et al. Limited extension after linked total elbow arthroplasty in patients with rheumatoid arthritis. Mod Rheumatol. 2015 Sep 7:1-14 [Epub ahead of print]
    27. Pooley J, Salvador Carreno J. Total elbow joint replacement for fractures in the elderly -- functional and radiological outcomes. Injury. 2015 Sep 8 [Epub ahead of print].


You are now leaving the Aetna website.

Links to various non-Aetna sites are provided for your convenience only. Aetna Inc. and its subsidiary companies are not responsible or liable for the content, accuracy, or privacy practices of linked sites, or for products or services described on these sites.

Continue >