Long-Term Study of CapFlex PIP Implant for Finger Joint Replacement in Osteoarthritis Patients Using Advanced Imaging

What this Trial Is About

Researchers are studying patients with osteoarthritis affecting the proximal interphalangeal PIP joint to understand the long-term behavior of the CapFlex PIP implant system. This implant is a modular surface replacement used in joint arthroplasty, which has shown good short-term results with few complications. The study aims to assess how well the implant attaches and whether it moves over time by using a special imaging technique called model-based roentgen stereogrammetric analysis mRSA across 10 years. Patients receive the CapFlex PIP implant as part of their regular treatment, during which small markers are placed in the bone around the implant. The study follows 36 patients, checking them before surgery and then at 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years after surgery. This allows researchers to track the implants movement in three directions, its survival, clinical function, and X-ray features over time. Participants will attend multiple visits for evaluations including imaging with RSA, clinical questionnaires about hand function and quality of life, and pain assessments. These extra visits occur alongside their usual care to help detect any problems with the implant early. The study measures changes in implant position, rotation, survival, and patient-reported outcomes, with follow-up lasting 10 years to provide detailed long-term information.

CapFlex PIP Implant RSA