Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study

February 26, 2024 updated by: Trygve Holm Glad, Oslo University Hospital

Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.

The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
  • Age 18-70 years
  • ASA class 1-3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Motec total wrist arthroplasty
Procedure: Motec total wrist arthroplasty
Active Comparator: Remotion total wrist arthroplasty
Procedure: Remotion total wrist arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRWHE (Patient rated Wrist and Hand Evaluation score)
Time Frame: 24 months postop
PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function
24 months postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrist movement
Time Frame: 24 months postop
Overall degree of flexion, extension, radial and ulnar deviation
24 months postop
Grip Strength
Time Frame: 24 months postop
24 months postop
Pain in affected wrist
Time Frame: 24 months postop
Visual analogue scale
24 months postop
Quick-DASH
Time Frame: 24 months postop
"Disabilities of the Arm, Shoulder and Hand" questionnaire
24 months postop
intraoperative complications
Time Frame: intraoperative
intraoperative
Postoperative complications
Time Frame: 24 months postop
24 months postop
Implant loosening
Time Frame: 24 months postop
Implant loosening seen on x-ray
24 months postop
Implant migration
Time Frame: 24 months postop
Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening
24 months postop
Periprosthetic bone mineral density
Time Frame: 24 months postop
BMD measured with DEXA (dual-energy x-ray absorptiometry)
24 months postop
Reoperations
Time Frame: 24 months postop
Reoperations of any cause
24 months postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Trygve Holm Glad, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Estimated)

November 1, 2034

Study Completion (Estimated)

November 1, 2034

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimated)

April 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-rheumatoid Wrist Arthritis

Clinical Trials on Motec total wrist arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe