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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Rheumatoid Arthritis
• Intervention / Treatment: Device: total wrist arthroplasty, Trimed

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Kurt Pettersson, MD, PhD; Phone Number: 0046196025190; Email: kurt.pettersson@orebroll.se
• Study Contact Backup: Name: Marcus Sagerfors, MD; Phone Number: 0046196025507; Email: marcus.sagerfors@orebroll.se

Study Locations

• Sweden
  • Orebro, Sweden, 70185
    • Recruiting
    • Department of Hand Surgery
    • Contact: Kurt Pettersson, MD, PhD; Phone Number: 0046196025190; Email: kurt.pettersson@orebroll.se
    • Contact: Marcus Sagerfors, MD; Phone Number: 0046196025507; Email: marcus.sagerfors@orebroll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Infection
• Substance abuse
• Mental illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Örebro Läns Landsting
• Investigators: Principal Investigator: Kurt Pettersson, MD, PhD, Orebro County Council, Orebro University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: wrist arthritis; total wrist arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: Orebro Lans landsting 01-14