Post-operative Results of the Trapezometacarpal (TMC) Prosthesis for Advanced Pre-operative Deformities

February 7, 2022 updated by: University Hospital, Montpellier

Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation

Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

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

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated with trapezometacarpal joint arthroplasty for trapezometacarpal joint arthritis

Description

Inclusion criteria:

  • Patient with TMC joint arthritis
  • Patient with adduction <25 degrees
  • Patients with Z deformity
  • Patient operated for TMC joint arthroplasty

Exclusion criteria:

- TMC arthroplasty implanted for fractures

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Mobility of the trapezometacarpal joint
Time Frame: 1 day
Mobility of the trapezometacarpal joint
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Grasping force measured
Time Frame: 1 day
Grasping force measured
1 day
Number of Participants with Pinching force
Time Frame: 1 day
Pinching force
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Michel CHAMMAS, PUPH, University Hospital, Montpellier

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 (Actual)

January 20, 2014

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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