Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-24

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rhizarthrosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Trapezectomy group

No interventions assigned to this group

Experimental

Arthroplasty group

HORUS

Intervention Type 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".

Interventions

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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".

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No