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

NCT02336009 | Unknown Phase 2

• 1 other identifier: Orebro Lans landsting 01-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Osteoarthritis

Keywords

wrist arthritis; total wrist arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• changes in patient related outcome measures (PROM)

  1, 2, 5, and 10 years postoperatively

• Changes in Range of Motion (ROM

  1, 2, 5, and 10 years postoperatively

Study Arms (1)

total wrist arthroplasty, Trimed

EXPERIMENTAL

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

Device: total wrist arthroplasty, Trimed

Interventions

total wrist arthroplasty, Trimed DEVICE

A new total wrist arthroplasty design. A pilot study.

total wrist arthroplasty, Trimed

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Infection
• Substance abuse
• Mental illness.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Örebro Läns Landsting: collaborator

Study Sites (1)

Department of Hand Surgery

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kurt Pettersson, MD, PhD

  Orebro County Council, Orebro University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurt Pettersson, MD, PhD

CONTACT

0046196025190; kurt.pettersson@orebroll.se

Marcus Sagerfors, MD

CONTACT

0046196025507; marcus.sagerfors@orebroll.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr Anil Gupta, MD, FRCA, PhD

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: January 12, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

SE (1)