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

Rheumatoid Arthritis Clinical Trial

Official title:

Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02336009
• Other study ID #: Orebro Lans landsting 01-14
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Örebro University, Sweden
• Contact: Kurt Pettersson, MD, PhD
• Phone: 0046196025190
• Email: kurt.pettersson[@]orebroll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Painful wrist arthritis

• Wrightington X-ray grade 2-4.

Exclusion Criteria:

• Infection

• Substance abuse

• Mental illness.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• total wrist arthroplasty, Trimed
A new total wrist arthroplasty design. A pilot study.

Locations

Country	Name	City	State
Sweden	Department of Hand Surgery	Orebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Örebro Läns Landsting

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Changes in Range of Motion (ROM	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