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.
A total of 64 patients will be included in the study based on a sample size calculation using
the MCID of Q-DASH. This number will also account for a maximum dropout rate of 18%. The
study will be a randomized clinical trial (RCT), where participants will be assigned to one
of the two surgical techniques through a randomized process. Patients will be monitored to
evaluate any differences between the techniques. The primary outcome measure will be the
patient-reported outcome using the QuickDASH assessment. Secondary outcomes will include pain
relief, questionnaires, radiographic changes, range of motion and strength (functional
outcome), readmission rates, complications, and revisions. Patients will undergo examinations
before the surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the
surgery. Additionally, patients will be contacted 5 and 10 years following the surgery for
further follow-up. The study will be conducted as a single-center study and all procedures
will be performed by one of three experienced hand surgeons.