Wrist Arthroplasty

Number: 0853

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Aetna considers total wrist arthroplasty medically necessary for rheumatoid arthritis affecting the wrist in persons who have radiographic evidence of wrist joint destruction with demonstrated resistance or failure to conservative medical treatment (3 or more months of non-steroidal antiinflammatory drugs (NSAIDS), disease modifying anti-rheumatic drugs (DMARDs), and/or glucocorticoids, as appropriate).

Aetna considers total wrist arthroplasty experimental and investigational for all other diagnoses including the following (not an all-inclusive list) because there is inadequate evidence in the peer-reviewed published clinical literature regarding its effectiveness for these indications:

• Comminuted distal radius fracture
• Kienbock's disease
• Osteoarthritis (incluidng osteoarthritis following distal radius fracture)
• Post-traumatic arthritis
• Scaphoid non-union
• Scapholunate dissociation.

Aetna considers the following devices / procedures experimental and investigational because their effectiveness has not been established (not an all-inclusive list):

• Integra Freedom Implant
• Pyrocarbon interposition arthroplasty for the treatment of pisotriquetral arthritis and scaphotrapeziotrapezoid osteoarthritis
• Semi-constrained distal radioulnar joint prosthesis
• The Prosthelast (an iso-elastic wrist implant)
• The Universal 2 total wrist system
• Wrist hemiarthroplasty for rheumatoid arthritis affecting the wrist and other indications (e.g., capitolunate arthritis, giant cell tumors of the distal radius, scaphoid nonunion advanced collapse, and scapholunate advanced collapse).

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Table:

CPT Codes / HCPCS Codes / ICD-10 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:
25446	Arthroplasty with prosthetic replacement; distal radius and partial or entire carpus (total wrist)
HCPCS codes not covered for indications listed in the CPB:
Universal 2 total wrist, Integra freedom implant, semiconstrained distal radioulnar joint prosthesis - no specific code:
ICD-10 codes covered if selection criteria are met:
M05.00 - M14.89	Rheumatoid arthritis
ICD-10 codes not covered for indications listed in the CPB:
S52.591+ - S52.599+	Other fracture of lower end of radius [comminuted]
Wrist hemiarthroplasty - no specific code:
ICD-10 codes not covered for indications listed in the CPB:
C40.00 - C40.02	Malignant neoplasm of scapula and long bones of upper limb [giant cell tumors of the distal radius]
M12.531 - M12.539	Traumatic arthropathy, wrist [scapholunate advanced collapse]
M19.031 - M19.039	Primary osteoarthritis, wrist
M19.131 - M19.139	Post-traumatic osteoarthritis, wrist
M19.231 - M19.239	Secondary osteoarthritis, wrist
S62.001K - S62.036K - 7th character must be "K"	Fracture of navicular [scaphoid] bone of wrist [nonunion]
Pyrocarbon interposition arthroplasty - no specific code :
Prosthelast - no specific code:
ICD-10 codes not covered for indications listed in the CPB:
M13.811 - M13.89	Other specified arthritis [pisotriquetral arthritis]
M19.041 - M19.049	Primary osteoarthritis, hand [scaphotrapeziotrapezoid osteoarthritis]

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Background

Total wrist arthroplasty (TWA) involves the implantation of a prosthetic joint, with the goals of reducing pain and preserving or increasing wrist mobility.  The procedure is almost always performed to relieve the symptoms of severe arthritis.  These components come in extra-small, small, medium, and large sizes to match patient anatomy.  To enable movement and prevent dislocation, the polyethylene spacer has a convex end that slides on the surface of a concave plate on the radial component. 

Several wrist implants have been developed since the early 1970s.  First-generation were silicone implants, such as those designed by Swanson in the 1980s.  Second-generation implants typically included 2 metal components that articulated by means of a ball-and-socket or a hemispheric design.  Many of these early implants were taken off the market because of problems with joint imbalance and dislocation.  The third generation of wrist prostheses were developed in an effort to better approximate the center of motion to prevent imbalance and dislocation.  Examples include the revised Meuli design (MWP III), as well as the Trispherical, the Universal, and the Biaxial designs, the latter of which has been discontinued.

Other Indications

Wollstein and Carlson (2013) stated that the most common forms of salvage surgery for wrist arthritis of any stage are four corner fusion and proximal row carpectomy.  Younger, high demand patients with early arthritis may not be candidates for this type of salvage surgery.  These investigators described a technique and preliminary case series of a minimal radio-carpal arthroplasty aimed at patients with initial and isolated wrist arthritis (stage 1).  This procedure does not preclude any procedure that may become necessary in the future.  A series of 19 male heavy laborers with scapho-lunate advanced collapse (SLAC grade 1 to 2) wrist osteoarthritis that felt the wrist arthritis was prohibiting their function enough to warrant surgery, but were unwilling to undergo a salvage procedure, were treated with the technique.  The average age was 57.2 (± 7.7) years.  The average follow-up period was 40.3 months (9 to 63 months).  All patients returned to heavy labor.  No revision surgery was needed within the follow-up period.  Range of motion (ROM) and grip strength did not significantly improve.  Patient satisfaction was high despite imperfect results.  The authors concluded that minimal arthroplasty as described may provide a temporary solution for active patients with symptomatic early wrist arthritis who are not candidates for salvage wrist surgery.  Moreover, they stated that longer-term follow-up as well as investigation of additional stabilization procedures is needed.

Boeckstyns et al (2013) noted that severely destroyed post-traumatic wrists are usually treated by partial or total wrist fusion or proximal row carpectomy.  The indications for and longevity of TWA are still unclear.  These researchers analyzed a series in which one last-generation TWA was used as a salvage procedure for wrists with severe arthritis due to traumatic causes.  The data were prospectively recorded in a web-based registry.  A total of 7 centers participated; 35 cases had a minimum follow-up time of 2 years.  Average follow-up was 39 (24 to 96) months.  Pain had improved significantly at follow-up, mobility remained unchanged.  The total revision rate was 3.7 %, and the implant survival was 92 % at 4 to 8 years.  Very few studies have described specific results after TWA in post-traumatic cases and almost none using classical "third-generation" implants.  The number of cases and the follow-up in the published series were small.  The authors concluded that although painful post-traumatic wrists with severe joint destruction can be salvaged by partial or total fusion; evaluated at short- to midterm, TWA can be an alternative procedure and gave results that were comparable to those obtained in rheumatoid cases.

Adams (2015) stated that newer implant designs and expanding experience have led to a gradual increase in the use of TWA for the treatment of post-traumatic arthritis. New challenges, however, may be encountered with this application, including bony deformities, previous or existing hard-ware, osteonecrosis, soft tissue injuries, and severe joint stiffness. Because the goals – to relieve pain and provide a functional ROM – are the same as for more common TWA indications, these technical challenges, along with often higher patient expectations, are important considerations. The author presented possible solutions to these unique surgical challenges, including important pre-operative planning to mitigate risks, and the expected outcomes in these patients.

Nicoloff et al (2015) noted that for decades design and development of TWA has been accompanied by quite a few failures, so that it has been rejected by most surgeons until today. The difficult and complex anatomy of the wrist led to different ways of development and often ended in an impasse. Compared to knee and hip arthroplasties, which could be conceived and developed further, a consistent method could not be applied. But in the last years some new concepts have established themselves, so that TWA is now not only applied in individual cases. The indications could be expanded and standardized. At the Hand-Center Lingen more than 400 TWAs have been performed since 2005. These researchers described the mid-term results (5 years since operation) of TWA in 162 patients; 41 % suffered from rheumatoid arthritis, the remaining diseases consisted of Kienbock's disease, osteoarthritis, osteoarthritis following distal radius fracture, post-traumatic arthritis, scaphoid non-union, and scapholunate dissociation. Three different types of TWA have been applied and their benefits and disadvantages were examined. In the follow-up these investigators found an improvement in the Quick-DASH of 34 points and 5.8 points on the visual analog scale (VAS). The ROM decreased in patients with rheumatoid arthritis (RA), but it increased in patients with other diseases. In both groups of patients these researchers found an increase of force. On the whole there was a rate of complications in an average rate of holding time of 3.7 %. There was no necessity for TWA removal and secondary wrist arthrodesis. The authors concluded that their uown very positive experience corresponded with the international comparison and it further encourages a standardized indication in TWA as an equivalent treatment.

Laulan et al (2015) stated that painful wrist osteoarthritis can result in major functional impairment. Most cases are related to post-traumatic sequel, metabolic arthropathies, or inflammatory joint disease, although wrist osteoarthritis occurs as an idiopathic condition in a small minority of cases. Surgery is indicated only when conservative treatment fails. The main objective is to ensure pain relief while restoring strength. Motion-preserving procedures are usually preferred, although residual wrist mobility is not crucial to good function. The vast array of available surgical techniques includes excisional arthroplasty, limited and total fusion, total wrist denervation, partial and total arthroplasty, as well as rib-cartilage graft implantation. Surgical decisions rest on the cause and extent of the degenerative wrist lesions, degree of residual mobility, and patient's wishes and functional demand. Proximal row carpectomy and 4-corner fusion with scaphoid bone excision are the most widely used surgical procedures for stage II wrist osteoarthritis secondary to scapho-lunate advanced collapse (SLAC) or scaphoid non-union advanced collapse (SNAC) wrist. Proximal row carpectomy is not indicated in patients with stage III disease. Total wrist denervation is a satisfactory treatment option in patients of any age; who have good ROM and low functional demands; furthermore, the low morbidity associated with this procedure makes it a good option for elderly patients regardless of their ROM. Total wrist fusion can be used not only as a revision procedure, but also as the primary surgical treatment in heavy manual laborers with wrist stiffness or generalized wrist-joint involvement. The authors concluded that the role for pyrocarbon implants, rib-cartilage graft implantation, and TWA remains to be determined, given the short follow-ups in available studies.

Comminuted Distal Radius Fracture

Schmidt (2015) presented 2 case reports of successful primary shortening of the forearm and TWA using the new angle-stable Maestro Wrist Reconstructive System (WRS) for treatment of highly comminuted distal radius fracture in selected autonomous patients. In a 56-year old male patient with adequate bone stock, insertion of the non-cemented Maestro WRS was combined with ulnar shortening osteotomy.  In an 84-year old female patient with poor osteoporotic bone stock, insertion of the radial cemented Maestro WRS was combined with ulnar head resection.  Both patients resumed their work without additional surgery after TWA.  At the 1-year follow-up, there were no changes in position of either implant without signs of loosening, no impingement, and no instability of the distal radioulnar joint or the distal ulna stump.  All clinical parameters (Disabilities of the Arm Shoulder and Hand [DASH] score, pain through VAS, and grip strength) were satisfactory.  Both patients reported that they would have the same procedure again.  The authors stated that further experience is needed to validate this concept.

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

Wrist Hemiarthroplasty

Wang and co-workers (2016) stated that giant cell tumor (GCT) of bone presenting in the distal radius is rare, however, when they occur, Campanacci grade-III tumors can present formidable reconstructive challenges.  They are associated with a high local recurrence rate with intra-lesional treatment, therefore approaches to reconstruct the wrist after en bloc resection warrant study.  These researchers examined:

1. what are the functional outcomes after en bloc resection and reconstruction of the wrist with a unipolar prosthesis in patients with grade-III GCT of the distal radius?
2. what complications occur with use of a unipolar prosthesis in these patients? and
3. what are the oncologic outcomes with using en bloc resection and reconstruction with a custom unipolar wrist hemiarthroplasty for grade-III GCTs of the distal radius?

These investigators retrospectively analyzed 10 patients with Campanacci grade-III GCTs of the distal radius treated by a unipolar prosthesis after wide resection of the tumor between January 2008 and October 2013.  During that period, all patients at the authors’ medical group who presented with a grade-III GCT of the distal radius were treated with wide resection and reconstruction using a custom unipolar implant.  Pre- and post-operative pain at rest were assessed according to a 10-cm VAS score.  The functional outcomes of the wrist were assessed using the modified Mayo wrist score, and the degenerative changes were evaluated radiographically by a new rating system based on the Knirk and Jupiter scale.  These researchers also analyzed tumor recurrence, metastases, and complications associated with the reconstruction procedure.  All patients were available for follow-up at a mean of 52 months (range of 24 to 90 months).  Although the complication rate associated with prosthetic arthroplasty was relatively high (6 of 10), none of the patients experienced severe complications; 2 patients reported having occasional pain of the involved wrist at the time of final follow-up (VAS, pre-operative versus post-operative: 0 versus 3; 5 versus 2, respectively).  The mean modified Mayo wrist score was 68 (range of 45 to 90).  Degenerative changes were found in 3 wrists (grade-I, 2 patients; grade-II, 1 patient).  Aseptic loosening occurred in 1 patient and wrist subluxation occurred in 2 patients.  Lung metastases or local tumor recurrence were not observed.  The authors concluded that due to the proportion of patients who had complications and progressive degeneration with this approach, they recommended first exploring alternatives to reconstruction with custom unipolar wrist hemiarthroplasty after resection of grade-III GCTs of the distal radius, such as fibular autografting.  This prosthesis also had the disadvantage of being a custom-made prosthesis, which might not be available in all countries.  However, this technique provided an alternative for patients with concerns regarding possible morbidity associated with autografting, and for situations when allograft is not available.  Moreover, they stated that a larger study is needed to confirm these preliminary findings, ideally comparing this approach with other types of reconstruction.  Level of evidence = IV.

Huish and colleagues (2017) noted that wrist hemiarthroplasty has emerged as a motion-sparing option for severe wrist arthritis.  It is technically easy with advantages of limited bone resection and no risk of nonunion.  Given the relative infancy of the procedure in clinical practice, there are limited data on patient outcomes.  In this study, a total of 11 patients were treated with wrist reconstructive hemiarthroplasty.  Indications included 1 patient with scaphoid nonunion advanced collapse, 9 patients with scapholunate advanced collapse, and 1 patient with capitolunate arthritis.  Average age was 63 years; average follow-up was 4 years.  Objective parameters included DASH, grip strength, and ROM.  Implant failure defined by necessity of revision procedure; DASH scores initially improved post-operatively but were not statistically significant.  Grip strength was 60 % of contralateral side.  Post-operative ROM at 6 months was flexion 40.3°, extension 39.3°, supination 87.0°, pronation 77.8°, radial deviation 14.5°, and ulnar deviation 13.8°. A 45 % failure rate was observed.  Complications included failure with conversion to TWA (n = 2) or wrist fusion (n = 3) secondary to development of ulnar-sided wrist pain.  One additional patient experienced severe wrist pain but declined additional surgery. The authors concluded that wrist hemiarthroplasty in this small series had a significant failure rate. In each case of failure, the patient developed ulnar-sided wrist pain.  In the presence of more reliable procedures, wrist hemiarthroplasty is not indicated in its current incarnation.

Herzberg and associates (2017) reported their experience with hemi-arthroplasty in irreparable fresh distal radius fracture in independent elderly patients as first-line treatment (12 fractures in 11 women; mean age of 74 years) or in second-line after clinically disabling primary failure (4 fractures in 4 women; mean age, of 78 years).  In the 12 primary surgeries, at a mean 32 months' follow-up, there were no complications requiring implant ablation; mean pain score was 1/10, flexion-extension 62°, Lyon wrist score 75 %, and patient-related wrist evaluation (PRWE) 22 points.  In 2 of the 4 secondary surgeries, at a mean 24 months' follow-up, there were no complications requiring implant ablation; mean pain score was 2.5/10, flexion-extension 62°, Lyon wrist score 58 %, and PRWE 50 points: i.e., slightly poorer results than in primary surgery.  The authors concluded that salvage of complex fracture in independent elderly patients by hemi-arthroplasty, whether primary or secondary to failure, appeared to be a considerable progress; however, these preliminary findings need to be confirmed in larger series.

Herzberg and associates (2018) updated their results of wrist hemiarthroplasty for irreparable distal radius fracture (DRF) in the elderly, at a minimum of 2-year follow-up.  Between 2011 and 2018, a total of 25 consecutive independent elderly patients (24 women, 27 wrists) were treated with wrist hemiarthroplasty for DRF at a single institution.  The average age was 77 years (range of 65 to 88).  They all were independent at home.  A total of 19 wrists were treated at the acute stage, and 8 secondary procedures.  The average follow-up was 32 months (range of 24 to 44).  There was no dislocation, loosening, infection nor removal of the implants.  These investigators observed 3 complex regional pain syndrome (CRPS).  At final follow-up, the average VAS pain was 1/10, mean forearm pronation/supination arc was 150°, and mean active flexion-extension arc was 60°.  Average wrist extension was 36°.  Mean grip strength was 68 % of contralateral side.  Mean Lyon wrist score was 74 %.  Mean Quick DASH score was 26 %, and mean PRWE score was 25 %.  The authors concluded that these findings suggested that treatment of acute irreparable DRF in the independent elderly patient with a bone-preserving primary wrist hemiarthroplasty may be a viable option.  Moreover, they stated that longer-term follow-up are needed to confirm these preliminary data.

The Prosthelast (an Iso-Elastic Wrist Implant)

Salazar Botero and colleagues (2018) described a new total wrist implant (Prosthelast) designed to reduce the risk of distal migration of the carpal component.  The Prosthelast implant consists in a 1-block radial implant replacing the metaphysis and the articular surface fixed to a radial elastic centro-medullar wire and a carpal component in titanium with an articular condylar surface in polyethylene.  These investigators operated on 5 patients (3 males and 2 females) and followed them up for 12 months on average; 2 of the patients presented with RA of the wrist, and an ulnar osteotomy (Darrach procedure) was carried out at the same time of the arthroplasty.  All clinical variables improved post-operatively (Quick DASH score, pain score, ROM) except from wrist flexion that was reduced.  No patients underwent revision surgery; 2 patients presented with a peri-prosthetic radiolucent loosening around the radial component, but no implant migration was observed.  The authors concluded that the preliminary findings of this case series showed that the new Prosthelast implant presented comparable short-term results to those described in the literature.  They will follow up the patients to verify that long-term results are as satisfactory as the short-term results.

Pyrocarbon Interposition Arthroplasty for the Treatment of Pisotriquetral Arthritis and Scaphotrapeziotrapezoid Osteoarthritis

Gauthier and associates (2017) reported the findings of arthroplasty using a mobile pyrocarbon implant (Pyrocardan) for isolated scaphotrapeziotrapezoid (STT) osteoarthritis (OA).  The hypothesis was that this arthroplasty leads to functional improvement without carpal instability.  A total of 20 patients (22 implants) were included with a minimum follow-up of 2 years and an average age of 59.6 years.  Outcome criteria were pain (VAS scale), Quick DASH (QDASH) and PRWE scores, strength (grip and pinch), wrist mobility, the Kapandji index, carpal height and the capitol-unar angle measured on X-rays.  The pre- and post-operative data were compared. The average follow-up was 3.8 years.  There was a significant improvement in pain, clinical scores and pinch strength.  In terms of ROM, these investigators found that amplitudes were maintained except for a significant decrease in wrist extension. X-rays did not show any carpal instability; carpal height was maintained and the capitol-unar angle was significantly improved.  No implant dislocation was reported.  The authors concluded that the good functional and radiographic outcomes, and the absence of surgical complications were evidence that the Pyrocardan resurfacing implant is a valid option for treating STT OA. Moreover, they stated that if this arthroplasty procedure fails, another procedure can still be done; but a long-term assessment of this technique is still needed.

Bellemere and co-workers (2018) stated that pisiformectomy is the baseline treatment for pisotriquetral arthritis when medical treatment fails to address the problem.  This operation may lead to loss of mobility and strength in the wrist.  These investigators reported the short-term outcomes of a new technique for treating pisotriquetral arthritis using a pisotriquetral interposition arthroplasty with a pyrocarbon implant. They performed a clinical and radiographic study on a series of 8 patients who received this treatment at a mean follow-up of 2.8 years.  They also studied the mobility of the implant and assessed articular instability using dynamic radiology and fluoroscopy.  These researchers observed 1 proximal dislocation of the implant in 1 hand, which was re-operated to re-position the implant and strengthen the capsule.  All patients were satisfied or very satisfied with their operation and had an average functional recovery period of 1.6 months.  At the last follow-up, the Mayo Wrist Score (MWS), QDASH, and PRWE scores were 89, 18, and 20, respectively. Post-operatively, there was a 22 % improvement in the grip strength of the wrists as well as improved mobility, mainly as regards the radio-ulnar deviation (47 % improvement) and the VAS pain scores decreased from 8 pre-operatively to 2 at the latest follow-up.  The functional radiologic and fluoroscopic study reported good adaptive mobility of the implant in all the patients, without any indication of pisotriquetral joint instability. The authors concluded that the short-term results of pisotriquetral arthroplasty using the Pyrocardan implant were encouraging.  They stated that this new surgical solution appeared to be a valid alternative to pisiformectomy or pisotriquetral arthrodesis. Moreover, they stated that long-term studies are needed to confirm these preliminary findings. 

Cholley-Roulleau et al (2021) stated that STT isolated OA mainly develops in women over 50 years of age in a bilateral manner.  Many surgical treatments are available, including distal scaphoid resection with or without interposition, trapeziectomy, and STT arthrodesis.  However, there is a controversy regarding which procedure is the most effective.  In a retrospective study, these investigators reported the outcomes of the Pyrocardan implant for treating STT isolated OA at a mean follow-up of 5 years.  Consecutive patients who underwent STT arthroplasty using the Pyrocardan were reviewed by an independent examiner who conducted a clinical and radiological evaluation.  The mean follow-up time was 5 years (range of 3 to 8 years); 13 patients (76 %) were followed-up for more than 5 years.  Between the pre-operative assessment and the last follow-up, pain levels decreased significantly.  There was no significant difference in the mean Kapandji opposition score.  Grip and pinch strengths were 88 % and 91% of the contralateral side . The active ROM in flexion-extension and radio-ulnar deviation was not significantly different to the contralateral side (119° versus 121° and 58° versus 52°, p > 0.1).  Functional scores were improved significantly.  No identifiable differences were found in the radio-scaphoid, capitolunate, and scapholunate angles before and after surgery.  In 3 cases, the pre-operative dorsal intercalated scapholunate instability (DISI) failed to be corrected.  In 1 case, DISI appeared after the procedure.  There was 1 asymptomatic dislocation of the implant.  Calcification around the trapezium and/or distal scaphoid was found in 4 cases.  The survival rate of the implant without re-operation was 95 %.  The authors concluded that in the medium-term, Pyrocardan implant was an effective treatment for STT isolated OA as it reduced pain, increased grip strength, and maintained wrist mobility.  This was consistent with the results of other published case series using pyrocarbon implants.  It provided a high rate of patient satisfaction; however, the surgical procedure must be performed carefully to avoid STT ligament damage, peri-articular calcifications, or dislocation.  Moreover, these researchers stated that careful removal of all bone fragments appeared important to minimize the risk of post-operative peri-articular calcification.  They stated that another study is needed to extend the follow-up period to ensure these findings are maintained on a long-term basis.

The authors stated that this study had several drawbacks.  First, it was a retrospective study, and these investigators did not compare different types of surgical procedure.  Second, not all pre-operative radiographs were available.  Third, these researchers had a limited sample size although it was within the range of similar published studies.  Nevertheless, they had the longest follow-up in the literature.  Fourth, these researchers did not compare the 2 available pyrocarbon implants (STPI and Pyrocardan).

The Universal 2 Total Wrist System

Brinkhorst and colleagues (2018) noted that many therapeutic options are available for wrist OA, with the objective of decreasing pain and preserving function.  In later stages when mid-carpal and radio-carpal OA occur, 2 choices remain: total wrist arthrodesis or total wrist arthroplasty.  These researchers presented the short-term functional changes following total wrist arthroplasty with the Universal 2 total wrist system (Integra Life Sciences) in patients with non-inflammatory wrist OA.  Patients with severe non-inflammatory wrist OA were assessed pre-operatively, 6 and 12 months after surgery using a ROM, grip strength, pain, and the DASH score.  The additional assessment was performed after 1 year for a ROM using a biaxial electro-goniometer, grip strength, DASH, and the Michigan hand questionnaire.  All ROM directions and grip strength did not change from pre-operative values.  The DASH score improved from 53 pre-operatively to 14 during latest follow-up.  Median patients' satisfaction score decreased with approximately 20 points during the last follow-up.  The authors concluded that the relatively good DASH score combined with the partly maintained wrist ROM indicated that reconstruction with the Universal 2 total wrist prosthesis should be considered in patients with end-stage non-inflammatory wrist osteoarthritis.  Level of Evidence = IV.  This study provided only short-term results (12 months); long-term follow-up data are needed to ascertain the safety and effectiveness of this prosthesis.

Zijlker and colleagues (2019a) noted that the Universal 2 is a total wrist implant that aims to maintain function of the wrist.  Promising mid-term results of the Universal 2 total wrist implant were described in the literature.  These researchers examined the long-term results in terms of implant survival and patient satisfaction.  Patients who received a Universal 2 implant between 2004 and 2009 were retrospectively identified through a data-base search.  Clinical outcome and complications of the implant were assessed by examination of the patient's medical records, X-rays, and a questionnaire, consisting of the Patient-Rated Wrist and Hand Evaluation questionnaire (PRWHE) and Quick DASH (QuickDASH) questionnaires and additional questions.  A total of 25 patients (26 wrists) were included in this study; 21 (81 %) Universal 2 implants remained in-situ after a mean follow-up of 11 years.  Moderate PRWHE (44) and QuickDASH (41) scores were found in these cases; 5 Universal 2 implants failed and were converted to a total wrist arthrodesis after a mean period of 9.2 years due to distal component loosening (n = 3), recurrent luxation (n = 1), or recurrent synovitis (n = 1); 23 (92 %) patients were (very) satisfied with the Universal 2 implant.  The authors concluded that the Universal 2 demonstrated a high (81 %) implant survival with a high patient satisfaction after a mean follow-up of 11 years.  Moreover, these researchers stated that prospective, long-term studies of the Universal 2 implant are needed to objectify improvement in wrist function and to provide a better comparison to other fourth-generation wrist implants.

The authors stated that this study had several drawbacks.  First, and perhaps most importantly, no pre-operative patient-reported outcome measures (PROMs) were available so it was impossible to comment on improvement or deterioration of wrist function as perceived by the patients.  However, one may assume an improvement since most patients were satisfied as demonstrated by the additional questionss.  Second, no objective outcome measures, like strength and ROM, were collected pre-operatively nor post-operatively.  Third, statistical analysis was not performed because of the small sample size.  Finally, this study was prone to selection bias due to the retrospective study design and only 50 % of the patients who were treated with the Universal 2 implant were included; the other 50 % was lost to follow-up, which was also an evident weakness of this study.

Zijlker et al (2019b) stated that Universal 2 implants may be an alternative to total wrist arthrodesis for the salvage of failed Biaxial total wrist prostheses.  These investigators evaluated 40 Universal 2 revision implants retrospectively; 14 of these wrists were converted to total wrist arthrodeses, and 2 wrists received a third TWA after a mean period of 5.5 years; 24 of the Universal 2 implants that remained in-situ after a mean follow-up of 9 years (range of 4 to 13 years) were re-examined, and 16 functioned satisfactorily.  Patient-Rated Wrist and Hand Evaluation scores and QuickDASH scores were 53 and 47, respectively; 29 patients would choose the Universal 2 again and would also recommend it to other patients.  The survival of the revision implants was 60 % at a mean follow-up of 9 years.  Level of evidence = IV.

The authors stated that loosening of the distal component remains a major problem in revision implants.  In their opinion, a revision system that provides less stress on the carpal fixation points might give better results and avoid failures.  The polyethylene component of the Re-motion implants (Stryker, Kalamazoo, MI) allows a rotational articulation of 20° with the carpal plate.  These investigators believed this reduces stress on the carpal fixation points.  For this reason, they have been using the Re-motion implant as salvage procedure for failed BIAX implants since 2015.

In a retrospective study, Gendera and colleagues (2020) reported medium-term outcomes of 14 total wrist arthroplasties in patients with especially, non-rheumatoid, degenerative OA and post-traumatic OA with a mean follow-up of 5 to 10 years.  Information of 14 patients (6 men and 8 women) with a mean age of 61 years, was collected before and after total wrist arthroplasty (Universal 2 prosthesis) performed by a single surgeon.  Pre-operative mobility was determined by ROM and compared to post-operative ROM.  Post-operative function was determined using the DASH score and the score.  Grip force between the operated and non-operated hand were compared post-operatively; 3 patients experienced complications.  Post-operatively, ROM improved although not significantly, due to an increase in palmar flexion.  The mean DASH score was 20 % and the mean total PRWE was 54 %.  The authors concluded that the findings of this study showed that total wrist arthroplasty, using the Universal 2 wrist prosthesis, provided reasonable results (survival rate of 84 %) by decreasing pain while preserving ROM in patients with degenerative OA of the wrist after 5 years; however, the 10-year survival rate decreased steeply to an unsatisfying 35 %.

Motec Total Wrist Arthroplasty

Lin and Paksima (2017) stated that TWA, first performed in the late 19th Century, is still an infrequently used operation.  It is most frequently indicated in patients with RA who have pan-carpal wrist involvement.  It is an alternative to total wrist arthrodesis in patients who wish to preserve joint motion.  Patients must lead a low-demand lifestyle and have failed non-operative measures.  Complications are not insignificant and have been reported to be as high as 43 %.  Modern generation implants most often fail due to dislocation or loosening.  The authors concluded that because wrist arthrodesis remains the gold standard therapy, especially in patients with higher physical demands, it remains to be seen whether TWA will gain greater acceptance as prosthetic designs evolve.

Gil and co-workers (2017) noted that TWA has been described as traditionally being performed with fixation in the radius and carpus with cement.  The TWA implant used by these investigators has been associated with promising results in studies with up to 6 years follow-up; however, studies evaluating survivorship, pain, and function with this implant are limited.  In a retrospective case-series study, these researchers reported ROM and pain scores after wrist reconstruction with cementless fourth-generation TWA at a mean follow-up of 9 years (range of 4.8 to 14.7); and reported complications of a cementless fourth-generation TWA and the cumulative probability of not undergoing a revision at a mean follow-up of 9 years.  This trial included a total of 69 patients who were treated for pan-carpal wrist arthritis between 2002 and 2014.  Of those, 31 had inflammatory arthritis (RA; n = 29, juvenile RA; n = 1, and psoriatic arthritis; n = 1); all of these patients received TWA with the cementless implant studied in this investigation.  Another 38 patients had OA or post-traumatic arthritis; in this subgroup, 28 patients were 65 years or younger, and all underwent wrist fusion (none was offered TWA); 10 patients with OA were older than 65 years and all were offered TWA; of those, 8 underwent TWA, and 2 declined the procedure and instead preferred and underwent total wrist arthrodesis.  The mean age of the 39 patients who had TWA was 56 ± 8.9 years (range of 31 to 78) at the time of surgery; 36 were women and 3 were men.  The patients who underwent TWA were seen at a minimum of 4 years (mean of 9 years; range of 4 to 15 years), and all had been examined in 2016 as part of this study except for 1 patient who died 9 years after surgery.  The dominant wrist was involved in 60 % (25) of the patients.  All patients were immobilized for 4 weeks post-operatively and then underwent hand therapy for 4 to 6 weeks.  Pain and ROM were gathered before surgery as part of clinical care, and were measured again at latest follow-up; at latest follow-up, radiographs were analyzed (by the senior author) for evidence of loosening, defined as any implant migration compared with any previous radiograph with evidence of peri-implant osteolysis and bone resorption.  Subjective pain score was assessed by a verbal pain scale (0 to 10) and ROM was measured with a goniometer.  Complications were determined by chart review and final examination.  Kaplan Meier survival analysis was performed to estimate the cumulative probability of not undergoing a revision.  The mean pre-operative active ROM was 34o ± 18° flexion and 36° ± 18° extension.  Post-operatively, the mean active ROM was 37° ± 14° flexion and 29° ± 13° extension.  The mean difference (MD) between the pre-operative pain score (8.6 ± 1.2) and post-operative pain score (0.4 ± 0.8) was 8.1 ± 1.9 (p < 0.001).  Implant loosening occurred in 3 (7.7 %) patients.  No other complications occurred in this series.  Kaplan-Meier survivorship analysis estimated the cumulative probability of remaining free from revision as 78 % (95 % confidence interval [CI]: 62 % to 91 %) at 15 years.  The authors concluded that cementless fourth-generation TWA improved pain while generally preserving the pre-operative arc of motion.  The cumulative probability of remaining free from revision at 14.7 years after the index procedure was 77.7 % (95 % CI: 62.0 % to 91.4 %).

The authors stated that the findings of this study as well as those of previous investigations that assessed the same system used in this trial suggested that the fourth-generation implant may be more durable, and the TWA has shifted from a surgical option that is controversial to one that is more predictable and reliable for patients with RA and post-traumatic osteoarthritis.  Their experience and data from the current study have caused them to broaden their current indications in patients with OA and post-traumatic arthritis who are younger than 65 years.  These researchers stated that future studies are needed to examine if this would result in measurable improvements in patient-reported outcomes.  Furthermore, future studies should compare alternative approaches for patients with end-stage wrist arthritis; such evaluations, which might compare TWA implants, or TWAs with arthrodesis. will need to be multi-center, as the problem is relatively uncommon.

Giwa and colleagues (2018) noted that the Motec cementless modular metal-on-metal ball-and-socket wrist arthroplasty is an implant with promising intermediate results.  An alternative to primary wrist fusion, TWA is an option for active patients, who wish to retain their wrist function.  It is indicated in cases of degenerative OA, post-traumatic arthritis and rheumatoid (inflammatory) arthritis.  These researchers carried out a prospective review of patient demographics, pre- and post-operative DASH, MAYO wrist scores, ROM and grip strengths.  All complications in follow-up were recorded across the 4-year period.  This trial included a total of 25 implants on 23 patients over 5.5 years, mean age of 61 years; 8 women and 15 men; 10 patients with SLAC, 3 SNAC, 5 inflammatory and 7 patients with generalized OA.  Subjects showed significant improvements of MAYO and DASH scores post-operatively, as well as the flexion/extension arc and grip strengths.  There was just 1 case of implant loosening – the radial screw after a wound infection, which was revised with a longer screw.  Two implants were converted to Motec fusion due to pain.  One implant was dislocated and relocated.  The remaining patients have had good wrist function.  Only 6 patients were unable to return to work.  The authors concluded that similar to published studies, this series showed the Motec implant to be a good motion preserving alternative to total wrist fusion; providing promising mid-term results (4 years).

Karjalainen and associates (2018) described 2 cases of articulation-related failures resulting in revision surgery after a Motec TWA: 1 with an adverse reaction to metal debris and the other with an adverse reaction to polyether ether ketone.  In the first case, blood cobalt and chrome levels were elevated and magnetic resonance imaging (MRI) showed clear signs of a pseudotumor.  In the second case, subject had an extensive release of polyether ether ketone particles into the surrounding synovia due to adverse wear conditions in the cup, leading to the formation of a fluid-filled cyst sac with a black lining and diffuse lymphocyte-dominated inflammation in the synovia.  The authors recommended regular follow-up including x-rays, monitoring of cobalt and chrome ion levels, and a low threshold for cross-sectional imaging in patients who have undergone TWA with a Motec joint prosthesis.  These researchers noted that wear-related problems could also develop in implants in which polyether ether ketone was the bulk material.

Furthermore, there is a clinical trial on “Motec versus ReMotion total wrist arthroplasty - A prospective study” (2018) that is active, but not recruiting.  The objective of this trial is to determine the difference in the results between Motec and ReMotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.

The ReMotion Total Wrist System

Herzberg and associates (2012) reported the current findings of an international multi-center study of one last generation TWA ("ReMotion" Small Bone Innovation, Morristown, PA).  The first and second authors built a Web-based prospective database including clinical and radiological pre-operative and post-operative reports of "ReMotion" TWA at regular intervals.  The cases of 7 centers with more than 15 inclusions were considered for this article.  A total of 215 wrists were included.  In the RA (129 wrists) and non-RA (86 wrists) groups, there were respectively 5 % and 6 % complications requiring implant revision with a survival rate of 96 % and 92 %, respectively, at an average follow-up of 4 years.  Within the whole series, only 1 dislocation was observed in 1 non-RA wrist.  A total of 112 wrists (75 RA and 37 non-RA) had more than 2 years of follow-up (minimum of 2 years, maximum of 8 years).  In RA and non-RA group, VAS pain score improved by 48 and 54 points, respectively, and QuickDASH score improved by 20 and 21 points, respectively, with no statistical differences.  Average post-operative arc of wrist flexion-extension was 58 degrees in rheumatoid wrists (loss of 1 degree) compared with 63 degrees in non-RA wrists (loss of 9 degrees) with no statistical differences.  Grip strength improved respectively by 40 % and 19 % in RA and non-RA groups (p = 0.033).  Implant loosening was observed in 4 % of the RA wrists and 3 % of the non-RA wrists with no statistical differences.  A Web-based TWA international registry was presented.  The authors concluded that these findings suggested that the ReMotion TWA was feasible in the mid-term and may be used in selected non-RA patients.  Moreover, these researchers stated that these findings need to be confirmed at a longer follow-up.  The authors stated that this study had several drawbacks.  It wa a multi-center study, and the current follow-up was only a mid-term follow-up.  The radiographs were not gathered electronically and the radiological criteria were based on surgeon's judgment.  This may have led to slightly different interpretations.  Level of evidence = IV.

Yeoh and Tourret (2015) reviewed the evidence on total wrist replacement from the last 5 years; 8 articles met a minimum set standard.  The results of 405 prostheses were available, including 7 different manufacturers.  The mean follow-up was 2.3 to 7.3 years with an average age of 52 to 63 years.  Rheumatoid arthritis was the indication in 42 % of patients.  Motec demonstrated the best post-operative DASH scores.  Only Maestro achieved a defined functional ROM post-operatively.  Universal 2 displayed the highest survival rates (100 % at 3 to 5 years), while Elos had the lowest (57 % at 5 years).  Bi-axial had the highest complication rates (68.7 %), while Remotion had the lowest (11 %).  Wrist arthroplasty preserves some ROM; functional scores improved and were maintained over the mid- to long-term.  Complication rates were higher than wrist fusion, with reports of radiological loosening and osteolysis.  The authors stated that the evidence does not support the widespread use of arthroplasty over arthrodesis, and careful patient selection is essential.

Froschauer and colleagues (2019) examined outcomes of the ReMotion Total Wrist System in 39 non-rheumatoid patients.  The mean follow-up was 7 years (range of 3 to 12).  Post-operative wrist flexion-extension and radial-ulnar deviation as well as the scores of the DASH questionnaire and the VAS pain scores improved significantly.  Complications occurred in 13 wrists, 5 of which required further surgery.  The most frequent complication was impingement between the scaphoid and the radial implant (n = 5), which can be avoided by complete or almost complete scaphoid resection.  Peri-prosthetic radiolucency developed around the radial component in 3 cases and 3 radial screws loosened.  The authors concluded that despite the incidence of high implant survival in 38 of 39 wrists over 7 years (97 %), the complication rate was not satisfying.  These researchers stated that knowledge of the risk of complications and patient selection are essential when making the decision to choose wrist arthroplasty over arthrodesis.  Level of evidence= IV.

Long-Term Follow-Up of Total Wrist Arthroplast

Matsui and associates (2020) examined the longitudinal clinical outcomes using a new semi-constrained wrist prosthesis for the treatment of severe RA of the wrist.  A total of 20 patients with RA (20 wrists) underwent TWA with the prosthesis in a clinical trial.  The pre-operative Larsen classification was grade-IV in 16 wrists and grade-V in 4 wrists.  Assessments were performed before surgery, 1.5 years after surgery, and at final follow-up (greater than or equal to 5 years after surgery) using the VAS for pain, Figgie wrist score, Japanese version of the DASH questionnaire, and plain radiographs.  At final follow-up, no patient had wrist pain.  The pre-operative flexion-extension arc at final follow-up was similar to the pre-operative range.  The mean 1.5-year post-operative Figgie score was significantly improved and was unchanged at final follow-up.  The DASH score significantly improved from before surgery to 1.5 years after surgery; the DASH score was improved further at final follow-up, but not significantly; 5 of the 19 wrists evaluated had radiographic findings indicating carpal component loosening at final follow-up; however, all patients with the loosening were asymptomatic and had not undergone revision surgery.  The authors concluded that TWA using this wrist prosthesis led to favorable clinical outcomes regarding pain relief and retained ROM of the wrist

Fischer and colleagues (2020) examined long-term implant survival in TWA, comparing 4 different implants.  In a prospective cohort of 124 patients, 136 TWAs were evaluated 5 years and 10 years after surgery.  The TWAs were implanted between 2005 and 2009.  The primary outcome was implant survival.  Survival analysis was performed with revision and radiographic loosening as the final end-point.  Revision was defined as exchange of whole or parts of the prosthesis.  Implant loosening was assessed using radiographic examination at the 5-year and 10-year follow-up. Secondary outcome measures included wrist ROM, hand grip strength, VAS pain scores, and PROMs, including DASH, PRWE, and Canadian Occupational Performance Measure (COPM). Total cumulative implant survival was 92 % with revision as the primary end-point.  When including a non-revised radiographic loose implant as a failure, total implant survival was 75 %. Radiographic loosening differed significantly between the implants with a range in frequency from 0 % to 37.5 %.  At the 10-year follow-up, assessing the non-revised TWAs, ROM was preserved compared with pre-operative values.  Significant improvement was recorded for hand grip strength, VAS pain scores, and patient-related outcome measures at the 10-year follow-up compared with pre-operative values.  The authors concluded that high 10-year implant survival was found when defining the primary end-point as revision of any cause.  When including radiographic loosening of the implant in the survival analysis, implant survival was considerably lower.  However, radiographic loosening did not appear to correlate with changes in secondary outcome measures, questioning the need for revision surgery in these cases.

Integra Freedom Implant

Rossello et al (2022) stated that recent innovations in wrist arthroplasty implants have led to remarkable improvements in terms of results with improved stability and preservation of bone stock.  Despite the advances in such implants, poor outcomes and frequent complications still affect this procedure, not allowing a wider use of this treatment in wrist arthritis.  In a case-series, pilot study, these researchers examined the preliminary, mid-term results of a Wrist Arthroplasty System (Freedom, Integra Lifesciences, Princeton, NJ) in patients with RA or secondary OA of the wrist and proposed a new classification system.  They examined 12 patients (7 with RA and 5 with secondary OA of the wrist) who underwent total wrist arthroplasties carried out by a single surgeon using the 4th-generation prosthesis.  Pre- and post-operative pain on a VAS, functional parameters measured with Mayo Wrist score, patient-rated wrist evaluation score, ROM, and radiographic analysis were collected.  At a mean follow-up of 48 (SD 16.9) months a significant improvement (p < 0.0001) of the mean VAS, Mayo and PRWE scores following total wrist arthroplasty was observed.  Wrist movements improved significantly (p < 0.001).  The authors achieved significant improvements in pain relief, performance, and satisfaction both in rheumatic and non-rheumatic patients, confirmed by our scoring system.  These preliminary findings from a pilot study with mid-term results need to be validated by well-designed studies with long-term follow-up.  Level of Evidence = IV. 

Semi-Constrained Distal Radioulnar Joint Prosthesis

Warlop et al (2021) stated that a painful unstable distal radio-ulnar joint (DRUJ) can seriously compromise hand and wrist function.  The semi-constrained prosthesis was developed to restore DRUJ function.  To-date, most outcome reports were co-authored by the designer.  These investigators examined if independent reporting would confirm the promising results of the semi-constrained DRUJ prosthesis; and if the complication and failure rates are acceptable.  They evaluated patients with the semi-constrained DRUJ implant and a minimum follow-up of 2 years.  These researchers monitored patient satisfaction and function with functionality questionnaires and measured wrist ROM, grip, and key pinch strength.  Statistical analysis was carried out using descriptive statistics, Pearson correlation coefficients, linear and logistic regression.  This study included 41 patients with 42 implants; mean follow-up was 46 months (range of 24 to 102 months); 80 % of wrist had undergone previous surgery.  These investigators found a mean pronation of 83 degrees (0 to 90 degrees), supination of 70 degrees (0 to 90 degrees), flexion of 42 degrees (0 to 90 degrees), extension of 49 degrees (0 to 90 degrees), ulnar deviation of 24 degrees (0 to 60 degrees), and radial deviation of 14 degrees (0 to 40 degrees).  Grip and key pinch strength were 20.1 (1 to 50 kg) and 6 kg (1 to 12 kg), respectively.  Average patient-rated wrist and hand evaluation score was 42.7 (0 to 95), DASH score was 38 (0 to 88), and VAS score was 3.6 (0 to 8).  They found a 43 % complication rate (mostly minor: ulnar or radial tendinopathy, temporary hypoesthesia) with 24 % re-operation and 92 % prosthesis survival rate.  The authors concluded that the linked semi-constrained DRUJ prosthesis has its value in the surgical treatment of DRUJ failure.  Currently, most implants are used in secondary surgery and multi-operated wrists.  These investigators stated that more research is needed to determine the value of the DRUJ prosthesis as a primary procedure.  Level of Evidence = IV.

Amundsen et al (2022) noted that the use of implant arthroplasty in the DRUJ is increasing.  Two main types of implants are commonly used, ulnar head prosthesis (UHP) and hemi or semi-constrained total DRUJ arthroplasty.  The literature consists mainly of small patient series.  These researchers examined their long-term outcomes of DRUJ arthroplasty.  Patient data were collected in a patient registry from 2000 to 2019.  The follow-up included radiographic examination, physical examination, Mayo Wrist Scores, pain level, ROM, and grip strength.  Re-operations were recorded.  The implants were a semi-constrained prosthesis and a metallic UHP.  The mean age at surgery was 50 years.  Patient demographics were similar; however, the semi-constrained group had a higher pre-operative percentage of instability (85 % versus 52 %).  The median follow-up time was 30 months for the semi-constrained implants group and 102 months for the UHP group.  A total of 53 primary semi-constrained total joint arthroplasties and 102 UHPs were included.  The grip strength and Mayo Wrist Score improved for both the implant groups.  Pain reduced in 76 % of the patients.  Supination improved for the semi-constrained total joint arthroplasty group.  Lifting capacity was better in the semi-constrained total joint arthroplasty patients.  The unadjusted re-operation rate was 23 % for the semi-constrained implants group and 34 % for the UHP group; 22 implants were bilateral; these had comparable results to unilateral implants.  Kaplan-Meier survival curves demonstrated 94 % survival rate for the semi-constrained implants group and 87 % survival for the UHP group after 5 years.  The risk factors associated with re-operation for the combined implant group included younger age at surgery, previous wrist surgery, ulnar shortening, and wrist fusion.  The authors concluded that DRUJ arthroplasty improved functional outcomes in both the implant groups; however, re-operations were frequent.  The semi-constrained implants group exhibited better lifting capacity.  Furthermore, the bilateral implants had comparable outcomes to the unilateral implants.  Level of Evidence = IV.

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References