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

Örebro University, Sweden

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Osteoarthritis; Rheumatoid Arthritis

Treatments: Device: total wrist arthroplasty, Trimed

Study type: Interventional

Funder types: Other

Identifiers

NCT02336009

Orebro Lans landsting 01-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Infection
• Substance abuse
• Mental illness.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

total wrist arthroplasty, Trimed

Experimental group

Description:

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

Treatment:

Device: total wrist arthroplasty, Trimed