Osteochondral allograft implantation for thumb basal joint arthritis
Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
NA · Columbia University · NCT03722537
This will try implanting an osteochondral allograft during thumb surgery to see if it improves pain and function for adults with basal joint arthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03722537 on ClinicalTrials.gov |
What this trial studies
This interventional study compares the current standard surgical treatment for basal joint (thumb) arthritis to a newer procedure that implants an osteochondral allograft at the base of the thumb. Eligible adults undergoing operative management are enrolled and receive either the allograft procedure or the standard ligament reconstruction/tendon interposition approach. Patients are followed post-operatively at 1, 3, and 6 months and at 1 year to track pain, function, and complications. The study is conducted at Columbia University Irving Medical Center as a prospective surgical comparison.
Who should consider this trial
Good fit: Adults aged 18 or older who are indicated for operative management of basal joint arthritis and have not had prior surgery on that joint are ideal candidates.
Not a fit: Patients who are pregnant, incarcerated, or who have already had surgery for basal joint arthritis are excluded and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the procedure could reduce pain and improve thumb function while preserving joint anatomy.
How similar studies have performed: Osteochondral allografts have been used with some success in other joints, but their use in the thumb is novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Indicated for operative management of basal joint arthritis Exclusion Criteria: * Pregnant women/fetuses/neonates, prisoners * Previously operated on for treatment of basal joint arthritis
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Melvin P Rosenwasser, MD — Columbia University
- Study coordinator: Melvin P Rosenwasser, MD
- Email: mpr2@cumc.columbia.edu
- Phone: 212-305-8036
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.
Conditions: Basal Joint Arthritis, Allograft, Osteochondral Allograft, Arthritis