Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis

Launched by HERLEV AND GENTOFTE HOSPITAL · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two types of surgeries for people with osteoarthritis in the thumb joint, specifically the trapeziometacarpal joint. One group of participants will receive a new type of implant called Pyrocardan®, while the other group will undergo a standard surgery known as ligament reconstruction and tendon interposition (LRTI). The goal is to find out which option leads to better outcomes for patients.

To be eligible for this trial, participants must be at least 40 years old and have severe symptoms from their thumb osteoarthritis that haven't improved with non-surgical treatments. They should also be in good health to undergo surgery. A total of 64 patients will be included, and they will be evaluated at several points: before surgery, and then again at 3, 6, 12, and 24 months after the operation, with follow-ups at 5 and 10 years. Throughout the study, researchers will look at various outcomes, including how patients feel about their recovery, their ability to use their hands, and any complications that may arise. This trial is currently recruiting participants.

Gender

ALL

Eligibility 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