Comparing a new prosthesis to suspensionplasty for thumb arthritis treatment
Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
This study is testing whether a new thumb prosthesis works better than a common surgery for people with arthritis in their thumb.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació d'investigació Sanitària de les Illes Balears Government |
| Locations | 1 site (Palma De Mallorca, Islas Baleares) |
| Trial ID | NCT04562753 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy, safety, and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis compared to APL suspensionplasty for treating first carpometacarpal joint osteoarthritis. Patients will be randomly assigned to receive either the TMC prosthesis or undergo suspensionplasty, with their pain levels and quality of life assessed through questionnaires before and after treatment. The study seeks to determine which intervention provides better outcomes for patients suffering from this common form of arthritis in the thumb.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 or older with a diagnosis of first CMC osteoarthritis who have not responded to conservative treatments.
Not a fit: Patients with comorbid conditions affecting the hand or those who have had previous surgeries on the same hand may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and quicker recovery option for thumb arthritis.
How similar studies have performed: Other studies have explored similar surgical interventions for thumb arthritis, but this specific comparison of TMC prosthesis and suspensionplasty is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18 or older. * Diagnosis of First CMC OA. * Non-responses to conservative treatment. * Eaton Stage 2-3 * Physical and cognitive aptitudes to understand and give written informed consent. Exclusion Criteria: * Comorbidity with other medical conditions which would affect the hand (Carpal Tunnel Syndrome, De Quervain Tenosynovitis, Trigger Finger) * Rheumatoid Arthritis * Previous surgery in the same hand. * Rejection to participate
Where this trial is running
Palma De Mallorca, Islas Baleares
- Hospital Son Espases — Palma De Mallorca, Islas Baleares, Spain (Recruiting)
Study contacts
- Study coordinator: Serafin Lirola-Palmero, MD
- Email: slirola@ssib.es
- Phone: +34 971 205000
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.