Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Recruiting

• Conditions: Rhizarthrosis
• Interventions: Device: HORUS

• Registration Number: NCT06078189
• Lead Sponsor: Clinique Bizet

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.

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 Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Study Start: 2023-11-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2026-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	HORUS	Arthroplasty group

Primary Outcome Measures

Name	Time	Method
patient assessment of the wrist	4 weeks	Quick-Dash score (11 minimum value and 55 is maximum; )

Secondary Outcome Measures

Name	Time	Method
patient assessment of the wrist pain	4 weeks	Visual Analogical Assessment score (0 no pain 10 severe pain)

Trial Locations

Locations (1)

Clinique BIZET; 🇫🇷 Paris, France