Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

NCT07169474 | Recruiting

• 1 other identifier: TM2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trapeziometacarpal Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score

  Change in Quick DASH functional score between inclusion (preoperative) and one year postoperatively, from 0 = no disability to 100 = maximum disability.

  One year

Secondary Outcomes (8)

• Patient satisfaction

  3 months, 6 months and 12 months post-operative

• Complication or surgery

  One year

• Radiographic evaluation

  one year

• Pain in the operated hand

  3 months, 6 months and 12 months postoperatively

• Pinch and grip force

  3 months, 6 months and 12 months postoperatively

Study Arms (1)

Isolated trapeziometacarpal arthroplasty

EXPERIMENTAL

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.

Procedure: Isolated trapeziometacarpal arthroplasty with double mobility

Interventions

Isolated trapeziometacarpal arthroplasty with double mobility PROCEDURE

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

Isolated trapeziometacarpal arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique St jean sud de france

Montpellier, 34430, France

RECRUITING

Study Officials

• benjamin Degeorge

  Clinique Saint jean sud de france

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecile Spirito

CONTACT

0033467413399; cecile.spirito@capsante.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 11, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

FR (1)