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

NCT ID: NCT02336009

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-12-31

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.

Conditions

Rheumatoid Arthritis; Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

total wrist arthroplasty, Trimed

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

Group Type: EXPERIMENTAL

total wrist arthroplasty, Trimed

Intervention Type: DEVICE

A new total wrist arthroplasty design. A pilot study.

Interventions

total wrist arthroplasty, Trimed

A new total wrist arthroplasty design. A pilot study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Infection
• Substance abuse
• Mental illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Örebro Läns Landsting

OTHER_GOV

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Anil Gupta

dr Anil Gupta, MD, FRCA, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kurt Pettersson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orebro County Council, Orebro University

Locations

Department of Hand Surgery

Örebro, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Kurt Pettersson, MD, PhD

Role: CONTACT

kurt.pettersson@orebroll.se

0046196025190

Marcus Sagerfors, MD

Role: CONTACT

marcus.sagerfors@orebroll.se

0046196025507

Facility Contacts

Kurt Pettersson, MD, PhD

Role: primary

kurt.pettersson@orebroll.se

0046196025190

Marcus Sagerfors, MD

Role: backup

marcus.sagerfors@orebroll.se

0046196025507

Other Identifiers

Orebro Lans landsting 01-14

Identifier Type: -

Identifier Source: org_study_id