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

Phase 2

• Conditions: Rheumatoid Arthritis; Osteoarthritis
• Interventions: Device: total wrist arthroplasty, Trimed

• Registration Number: NCT02336009
• Lead Sponsor: Örebro University, Sweden

Brief Summary

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

Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures.

1. Patient related outcome measures: DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation.

2. Wrist range of motion: dorsal/volar flexion, ulnar/radial deviation, pronation/supination. Hand grip strength, pinch grip, key pinch.

3. Wrist pain. VAS-pain scores (Visual analog score) at rest and in activity.

4. X-ray findings. Implant survival will be studied with Kaplan-Meyer graphs.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Painful wrist arthritis
• Wrightington X-ray grade 2-4.

Exclusion Criteria

• Infection
• Substance abuse
• Mental illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
total wrist arthroplasty, Trimed	total wrist arthroplasty, Trimed	This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty.

Primary Outcome Measures

Name	Time	Method
revision rate	changes in revision rates up to 10 years postoperatively	The frequency of TWA implants revised up to 10 years after the index operation

Secondary Outcome Measures

Name	Time	Method
Changes in Range of Motion (ROM	1, 2, 5, and 10 years postoperatively	flexion, extension, radial and ulnar deviation, pronation, supination. Hand grip strength, pinch grip, lateral grip, and radiographic loosening, VAS-pain scores.
changes in patient related outcome measures (PROM)	1, 2, 5, and 10 years postoperatively	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

Trial Locations

Locations (1)

Department of Hand Surgery; 🇸🇪 Orebro, Sweden