Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

NCT06078189 | Recruiting DMC

• 1 other identifier: 2022-A02775-38
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhizarthrosis

Keywords

osteoarthritis - Trapezectomy

Outcome Measures

Primary Outcomes (1)

• patient assessment of the wrist

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

  4 weeks

Secondary Outcomes (1)

• patient assessment of the wrist pain

  4 weeks

Study Arms (2)

Control

Trapezectomy group

Experimental

Arthroplasty group

Device: HORUS

Interventions

HORUS DEVICE

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".

Experimental

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic disabling osteoarthritis in failure of medical treatment

You may qualify if:

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

You may not qualify if:

• Minor patient
• Trapezium height \< 8 mm
• Major subject protected by law, under curatorship or guardianship
• Known allergy to the materials of the medical device
• Local infection
• Local skin necrosis or unhealed wound
• Pregnant or nursing women

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (1)

Clinique BIZET

Paris, 75116, France

RECRUITING

Central Study Contacts

Bouchra BENKESSOU, PM

CONTACT

0764486016; b.benkessou@hexagone-santé-paris.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: October 11, 2023
• Study Start: November 24, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

FR (1)