Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

NCT ID: NCT07169474

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2027-07-30

Brief Summary

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The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms.

The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively.

The study design is a follow-up study of a multicenter cohort.

Detailed Description

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Conditions

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Trapeziometacarpal Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isolated trapeziometacarpal arthroplasty

Isolated TM arthroplasty with double mobility in all cases, using a MAIA (Laboratoire LEPINE) or TOUCH (Laboratoire KERIMEDICAL) prosthesis, depending on the surgeons' habits. Participating surgeons will follow a common operating protocol to ensure consistency of procedures.

Group Type EXPERIMENTAL

Isolated trapeziometacarpal arthroplasty with double mobility

Intervention Type PROCEDURE

Isolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits.

Interventions

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Isolated trapeziometacarpal arthroplasty with double mobility

Isolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient requiring surgical management
* Clinical and radiographic diagnosis of peri-trapezial osteoarthritis in the 1 or 2 joints:

TM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination

* TM (Eaton-Littler stages II to III) and STT (Crosby stages II and III) radiographic osteoarthritis
* Persistent pain and functional limitations despite conservative treatment for at least 6 months (combining intermittent immobilization of wrist and thumb + joint infiltration of the 2 joints)
* Ability to understand and sign the informed consent form.

Exclusion Criteria

* History of surgery on the affected thumb.
* Systemic inflammatory diseases (e.g. rheumatoid arthritis).
* Active infection or history of joint infection of the upper limb.
* Inability to participate in post-operative follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean, France

OTHER

Sponsor Role lead

Responsible Party

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Benjamin DEGEORGE

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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benjamin Degeorge

Role: PRINCIPAL_INVESTIGATOR

Clinique Saint jean sud de france

Locations

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Clinique St jean sud de france

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cecile Spirito

Role: CONTACT

0033467413399

Facility Contacts

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Cecile Spirito

Role: primary

00304 67 41 34 53

Other Identifiers

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TM2025

Identifier Type: -

Identifier Source: org_study_id

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