Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy (TRAPEzE)

January 2, 2026 updated by: Clinique Bizet

Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation

Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.

The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a two-center, randomized, prospective, comparative study.

The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.

The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75116
        • Recruiting
        • Clinique Bizet
        • Contact:
          • Bouchra BENKESSOU, MP
          • Phone Number: 0764486016
        • Principal Investigator:
          • Camille ECHALIER, DR
        • Sub-Investigator:
          • Jean- Noel GOUBIER, DR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic disabling osteoarthritis in failure of medical treatment

Description

Inclusion Criteria:

  1. Age >45 years
  2. Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
  3. Patient who has given his/her consent to participate in the study after being informed by the surgeon,
  4. Patient living in France and able to answer the survey alone.
  5. Subject affiliated to a social security system or beneficiary of such a system
  6. No participation in any other clinical study

Exclusion Criteria:

  1. Minor patient
  2. Trapezium height < 8 mm
  3. Major subject protected by law, under curatorship or guardianship
  4. Known allergy to the materials of the medical device
  5. Local infection
  6. Local skin necrosis or unhealed wound
  7. Pregnant or nursing women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Trapezectomy group
Experimental
Arthroplasty group
Device: HORUS
The trapezium-metacarpal arthroplasty consists of the installation of a bipolar prosthesis composed of a metacarpal implant and a trapezial implant articulated through a metacarpal "head".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient assessment of the wrist
Time Frame: 4 weeks

Quick-Dash score (11 minimum value and 55 is maximum

)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient assessment of the wrist pain
Time Frame: 4 weeks
Visual Analogical Assessment score (0 no pain 10 severe pain)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Bizet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A02775-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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