Maia thumb-joint prosthesis versus trapeziectomy with tenosuspension for thumb osteoarthritis
Official title: Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.
Run by Parc de Salut Mar · NCT07101887 · Data updated 2026-11-12
This trial tests whether replacing the thumb base joint with a Maia prosthesis or doing a trapeziectomy plus tenosuspension better reduces pain and improves function in people with mild-to-moderate rhizarthrosis over one year.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 61 (estimated) |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | June 30, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT07101887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with thumb osteoarthritis (rhizarthrosis) graded I–III who have not had prior related thumb surgery and who do not have severe osteoporosis, metal allergy, or joint malformations are ideal candidates.
✕Probably not a fit
Patients with advanced (grade IV) rhizarthrosis, severe osteoporosis, metal allergy, previous related surgeries, or anatomical malformations that prevent implant placement are excluded and unlikely to benefit from the prosthesis arm.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, prospective, single-blind trial enrolling 62 patients split into two equal groups to compare a Maia trapeziometacarpal prosthesis versus standard trapeziectomy with Burton-Pellegrini tenosuspension. Patients are followed for one year with primary outcomes of pain (VAS) and hand function (Quick-DASH) measured at intervals. Secondary outcomes include thumb strength, mobility, and Kapandji index scores. The trial is conducted at Hospital del Mar in Barcelona and includes patients with rhizarthrosis grades I–III while excluding grade IV, severe osteoporosis, metal allergy, prior related surgery, or joint malformations that prevent implantation.
Why it matters
Potential benefit: If successful, the prosthesis approach could provide better pain relief and improved hand function at one year compared with standard trapeziectomy for selected patients.
How similar studies have gone: Prior series and comparative studies of trapeziometacarpal prostheses have reported some improvements in pain and function but also higher rates of complications and revisions, so comparative evidence is mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rizarthrosis grade I, II, III Exclusion Criteria: * Rizarthrosis grade IV * Severe osteoporosis * Metals allergy * Previous surgical interventions related * Malformations in the articular zones that difficult the implant placement
Where it's running
-
Hospital del Mar
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Daniel Valverde Vilamala
- Email: dvalverde@hmar.cat
- Phone: +34 626330598
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.