Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07169474

Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Trapeziometacarpal Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Patients over 18 years of age who are members or beneficiaries of french social security

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: One year

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

Secondary outcomes

  1. Patient satisfaction

    Time frame: 3 months, 6 months and 12 months post-operative

    Likert satisfaction scale at 3 months, 6 months and 12 months post-operative. Chossing between very satisfied , Satisfied , No opinion , Dissatisfied or Very dissatisfied

  2. Complication or surgery

    Time frame: One year

    Need for repeat surgery and any post-operative complication during 12-month follow-up. Need for additional surgery on STT joint (= if pain on palpation and flexion/extension mobilization)

  3. Radiographic evaluation

    Time frame: one year

    Radiographic evaluation: absence of prosthesis complications

  4. Pain in the operated hand

    Time frame: 3 months, 6 months and 12 months postoperatively

    Visual Analogue Scale (VAS) for pain preoperatively at 3 months, 6 months and 12 months postoperatively, from 0 (no pain) to 10 (maximum pain).

  5. Pinch and grip force

    Time frame: 3 months, 6 months and 12 months postoperatively

    Pinch and grip force measured with dynamometer preoperatively, at 3 months, 6 months and 12 months postoperatively.

  6. Range of motion of the thumb

    Time frame: 3 months, 6 months and 12 months postoperatively

    Range of motion of the thumb measured relative to the 2nd metacarpal: antepulsion, retropulsion, abduction and adduction preoperatively, at 3 months, 6 months and 12 months postoperatively

  7. Wrist range of motion

    Time frame: 3 months, 6 months and 12 months postoperatively

    Wrist range of motion: flexion, extension, radial tilt and ulnar tilt preoperatively, at 3 months, 6 months and 12 months postoperatively

  8. Amplitude of possible metacarpophalangeal hyperextension

    Time frame: preoperatively at 3 months, 6 months and 12 months postoperatively

    Amplitude of possible metacarpophalangeal hyperextension preoperatively at 3 months, 6 months and 12 months postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile Spirito

CONTACT

[email protected]

0033467413399

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Official study title

Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.