Comparing two surgical options for thumb arthritis treatment
Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation
This study is testing whether a new surgery for thumb arthritis helps people over 45 recover better than the standard surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Clinique Bizet Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06078189 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the clinical and radiographic outcomes of two surgical treatments for rhizarthrosis: trapezectomy and arthroplasty. Conducted at two centers, it will evaluate functional recovery in patients over 45 years old who have not responded to medical treatment. Patients will be closely monitored for three months post-surgery to assess the short-term benefits of each procedure. The study seeks to determine if arthroplasty offers superior recovery compared to the standard trapezectomy.
Who should consider this trial
Good fit: Ideal candidates are individuals over 45 years old with symptomatic trapeziometacarpal osteoarthritis who have not benefited from prior medical treatments.
Not a fit: Patients with significant anatomical issues, such as trapezium height less than 8 mm, or those with local infections or allergies to the surgical materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical treatment for thumb arthritis, potentially improving recovery outcomes for patients.
How similar studies have performed: While trapezectomy is a standard treatment, the comparative effectiveness of arthroplasty is less established, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Clinique BIZET — Paris, France (Recruiting)
Study contacts
- Study coordinator: Bouchra BENKESSOU, PM
- Email: b.benkessou@hexagone-santé-paris.fr
- Phone: 0764486016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.