Comparing Pyrocardan® Implant to Standard Surgery for Thumb Osteoarthritis
Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis - A Randomized Controlled Trial
This study is testing if a new thumb implant called Pyrocardan® helps people with thumb arthritis recover faster and get stronger compared to standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT06290986 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares the effectiveness of the Pyrocardan® implant with the standard ligament reconstruction and tendon interposition (LRTI) for patients suffering from trapeziometacarpal osteoarthritis. The study will include Danish citizens referred to the orthopedic department at Copenhagen University Hospital in Herlev/Gentofte, with a total of 64 participants expected. Patients will be evaluated before surgery and at 3, 6, 12, and 24 months post-operation, focusing on patient-reported outcomes, functional outcomes, and complications. The aim is to determine if the Pyrocardan® implant leads to faster recovery and improved strength compared to LRTI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 and above with moderate to severe osteoarthritis of the thumb carpometacarpal joint who have not responded adequately to non-surgical treatments.
Not a fit: Patients under 40 years of age, those with cognitive impairments, or those with rheumatoid arthritis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective surgical option that leads to quicker recovery and better hand function.
How similar studies have performed: Previous studies on the Pyrocardan® implant have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Osteoarthritis of the trapeziometacarpal joint of the thumb. 2. Insufficient effect of non-surgical treatment with symptoms severe enough to justify surgical treatment. 3. ASA score 1-3, physically fit for surgery and rehabilitation Exclusion Criteria: 1. Below 40 years of age 2. Cognitive or linguistic impairment 3. Osteoarthritis in other carpal bones (STT OA and others) 4. Previous surgical treatment in the trapeziometacarpal joint. 5. Patients with rheumatoid arthritis
Where this trial is running
Hellerup
- Herlev and Gentofte Hospital — Hellerup, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens Joergsholm, MD — Herlev Gentofte Hospital
- Study coordinator: Jens Jørgsholm, MD
- Email: Jens.bertel.joergsholm.01@regionh.dk
- Phone: +4551339705
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.