Pyrocardan® Implant Arthroplasty or LRTI for Trapeziometacarpal Osteoarthritis - A Randomized Controlled Trial

The Pyrocardan® is designed by Philippe Bellemere and has been used since 2009. It is a biconcave-shaped CMC-1 interposition implant. The biconcave shape converts the CMC-1 saddle joint into a cardan-like joint. The implant is suitable for Eaton grade 2 or 3. The advantages compared to LRTI are believed to be preserved thumb length, faster recovery following surgery, increased grip and pinch strengths and less subsidence of the CMC-1 joint.

Most recently results from the Bellemere group in 2020 have shown excellent results in 103 patients 5 years following surgery. A study by Gerace et al. reported a significant improvement in pain, QuickDASH and strength, with a revision rate of 4% and a survival rate at 96% at 5 years of follow-up. A recent review from 2022 reported 97% survival rate at 4 years and an estimated survival rate of 95% at 7 years from surgery.

The purpose of this randomized study is to compare Pyrocardan® implant (intervention group 1.) with ligament reconstruction and tendon interposition (LRTI), (intervention group 2.) in patients treated with mild to moderate CMC-1 osteoarthritis. There is to our knowledge no randomized controlled trial (RCT) studies on Pyrocardan® implant.

Hypothesis Pyrocardan® can provide a faster recovery following surgery, increased grip and pinch strengths and less subsidence of the CMC-1 joint compared to LRTI.

All patients referred to the Orthopedic Surgery Department, Hand Surgery Unit at Copenhagen University Hospital in Herlev/Gentofte with CMC-1 OA with pain in the thumb base and suspected degenerative changes and indication of surgical treatment will be eligible for inclusion. The following criteria will result in exclusion from participation in the study: Age under 40, cognitive or linguistic impairment, presence of osteoarthritis in other carpal bones, previous surgery in trapeziometacarpal joint or diagnosis of rheumatoid arthritis.