Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant

Study Overview
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Brief Summary
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Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty. Several implants are available on the market and they all have different pros and cons. One risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose, revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the likely alternative. Revision rates five years after the index operation have improved, however, they cannot yet compare with the results after a total hip arthroplasty. A newly designed TWA has been developed by the department of Hand Surgery, Örebro university Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers theoretical advantages and has been biomechanically tested at the Mayo clinic. This is a pilot study where patients operated with the TWA will be assessed pre and postoperatively according to study protocol in order to evaluate outcome after TWA radiologically, clinically and regarding patient perceived outcome measures.

Detailed Description
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Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures. Patient related outcome measures: DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation. Wrist range of motion: dorsal/volar flexion, ulnar/radial deviation, pronation/supination. Hand grip strength, pinch grip, key pinch. Wrist pain. VAS-pain scores (Visual analog score) at rest and in activity. X-ray findings. Implant survival will be studied with Kaplan-Meyer graphs.

Official Title
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Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant

Conditions
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Rheumatoid Arthritis, Osteoarthritis

Intervention / Treatment
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* Device: total wrist arthroplasty, Trimed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Painful wrist arthritis Wrightington X-ray grade 2-4. Exclusion Criteria: Infection Substance abuse Mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: total wrist arthroplasty, Trimed<br>This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty. | Device: total wrist arthroplasty, Trimed<br>* A new total wrist arthroplasty design. A pilot study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| revision rate | The frequency of TWA implants revised up to 10 years after the index operation | changes in revision rates up to 10 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in patient related outcome measures (PROM) | Assessed as DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation preoperatively and after 1, 2, 5, and 10 years postoperatively | 1, 2, 5, and 10 years postoperatively | 
| Changes in Range of Motion (ROM | flexion, extension, radial and ulnar deviation, pronation, supination. Hand grip strength, pinch grip, lateral grip, and radiographic loosening, VAS-pain scores. | 1, 2, 5, and 10 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrist arthritis, total wrist arthroplasty