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| Name | Class |
|---|---|
| Örebro Läns Landsting | OTHER_GOV |
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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.
Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total wrist arthroplasty, Trimed | Experimental | This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total wrist arthroplasty, Trimed | Device | A new total wrist arthroplasty design. A pilot study. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kurt Pettersson, MD, PhD | Contact | 0046196025190 | kurt.pettersson@orebroll.se | |
| Marcus Sagerfors, MD | Contact | 0046196025507 | marcus.sagerfors@orebroll.se |
| Name | Affiliation | Role |
|---|---|---|
| Kurt Pettersson, MD, PhD | Orebro County Council, Orebro University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hand Surgery | Recruiting | Örebro | 70185 | Sweden |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |