Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
wrist arthritis, total wrist arthroplasty
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.
Interventions
DEVICEtotal wrist arthroplasty, Trimed
A new total wrist arthroplasty design. A pilot study.
Sponsors
Örebro Läns Landsting
Örebro University, Sweden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Painful wrist arthritis * Wrightington X-ray grade 2-4.
Exclusion criteria
* Infection * Substance abuse * Mental illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Sweden
Contacts
Primary ContactKurt Pettersson, MD, PhD
Backup ContactMarcus Sagerfors, MD
Outcome results
None listed