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NCT05169099 Clinical Trial

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

Arthritis Clinical Trial

Official title:
Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05169099
Other study ID # RECHMPL21_0628
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2014
Est. completion date January 30, 2022

Study information
Verified date February 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date January 30, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Mobility of the trapezometacarpal joint Mobility of the trapezometacarpal joint 1 day
Secondary Number of Participants with Grasping force measured Grasping force measured 1 day
Secondary Number of Participants with Pinching force Pinching force 1 day
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