Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02336009|
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : August 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Osteoarthritis||Device: total wrist arthroplasty, Trimed||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: total wrist arthroplasty, Trimed
This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty.
Device: total wrist arthroplasty, Trimed
A new total wrist arthroplasty design. A pilot study.
- revision rate [ Time Frame: changes in revision rates up to 10 years postoperatively ]The frequency of TWA implants revised up to 10 years after the index operation
- changes in patient related outcome measures (PROM) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336009
|Contact: Kurt Pettersson, MD, PhDemail@example.com|
|Contact: Marcus Sagerfors, MDfirstname.lastname@example.org|
|Department of Hand Surgery||Recruiting|
|Orebro, Sweden, 70185|
|Contact: Kurt Pettersson, MD, PhD 0046196025190 email@example.com|
|Contact: Marcus Sagerfors, MD 0046196025507 firstname.lastname@example.org|
|Principal Investigator:||Kurt Pettersson, MD, PhD||Orebro County Council, Orebro University|