NCT05169099

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2014

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

8 years

First QC Date

November 1, 2021

Last Update Submit

February 7, 2022

Conditions

RhizarthrosisArthritis

Keywords

Trapezometacarpal joint arthritisAdduction angle <25 degreesDecrease of the grasping and pinching forcesZ deformity of the thumb

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Mobility of the trapezometacarpal joint

    Mobility of the trapezometacarpal joint

    1 day

Secondary Outcomes (2)

  • Number of Participants with Grasping force measured

    1 day

  • Number of Participants with Pinching force

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated with trapezometacarpal joint arthroplasty for trapezometacarpal joint arthritis

You may qualify if:

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

You may not qualify if:

  • \- TMC arthroplasty implanted for fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Michel CHAMMAS, PUPH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

December 23, 2021

Study Start

January 20, 2014

Primary Completion

January 1, 2022

Study Completion

January 30, 2022

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

FR(1)