Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Study Overview
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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.

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.

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

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Device: HORUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Trapezectomy group | |
| Experimental<br>Arthroplasty group | Device: HORUS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis - Trapezectomy