Isolated thumb‑base (trapeziometacarpal) joint arthroplasty with double‑mobility for peritrapezial osteoarthritis in 300 patients
Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty
This trial will try an isolated double‑mobility thumb‑base joint replacement to see if it improves pain and hand function in adults with trapeziometacarpal osteoarthritis who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Saint Jean, France Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT07169474 on ClinicalTrials.gov |
What this trial studies
This multicenter follow-up cohort will enroll 300 adults undergoing isolated trapeziometacarpal arthroplasty with a double‑mobility implant for peritrapezial osteoarthritis. Patients are evaluated preoperatively and followed for at least one year, with the primary outcome being the change in QuickDASH functional score from baseline to one year post‑op. Eligible participants have radiographic TM (Eaton II–III) or STT (Crosby II–III) disease and persistent symptoms after ≥6 months of conservative care; key exclusions include prior thumb surgery, systemic inflammatory disease, or active joint infection. Standardized surgical technique and postoperative follow‑up protocols are applied across the participating centers.
Who should consider this trial
Good fit: Adults (≥18) with radiographic TM or STT osteoarthritis, persistent pain and functional limitation after at least six months of conservative treatment, who are candidates for surgery and covered by French social security.
Not a fit: People with systemic inflammatory arthritis, active or prior joint infection, prior surgery on the affected thumb, or those unable to attend postoperative follow‑up are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce thumb‑base pain and improve hand function and daily activities for people with this form of osteoarthritis.
How similar studies have performed: Thumb‑base arthroplasty has previously shown pain relief and functional gains in other studies, while double‑mobility implant designs are a newer variation with limited but growing supportive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:- Patients over 18 years of age who are members or beneficiaries of french social security * Patient requiring surgical management * Clinical and radiographic diagnosis of peri-trapezial osteoarthritis in the 1 or 2 joints: TM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination * TM (Eaton-Littler stages II to III) and STT (Crosby stages II and III) radiographic osteoarthritis * Persistent pain and functional limitations despite conservative treatment for at least 6 months (combining intermittent immobilization of wrist and thumb + joint infiltration of the 2 joints) * Ability to understand and sign the informed consent form. Exclusion Criteria: * History of surgery on the affected thumb. * Systemic inflammatory diseases (e.g. rheumatoid arthritis). * Active infection or history of joint infection of the upper limb. * Inability to participate in post-operative follow-up.
Where this trial is running
Montpellier
- Clinique St jean sud de france — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: benjamin Degeorge — Clinique Saint jean sud de france
- Study coordinator: Cecile Spirito
- Email: cecile.spirito@capsante.fr
- Phone: 0033467413399
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.