Evaluating the CapFlex PIP implant for osteoarthritis in the hand
Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study
This study is testing how well the CapFlex PIP implant works for people with osteoarthritis in their finger joints over 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Reinier Haga Orthopedisch Centrum Academic / other |
| Locations | 1 site (Zoetermeer, South Holland) |
| Trial ID | NCT05484089 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the fixation and migration patterns of the CapFlex PIP implant in patients with osteoarthritis of the proximal interphalangeal joint. Using model-based roentgen stereogrammetric analysis (mRSA), the study will track the implant's performance over a 10-year period. The primary focus is on understanding how the implant behaves in vivo, while secondary objectives include analyzing survival rates, clinical scores, and radiographic outcomes. A total of 36 patients will be enrolled for this prospective cohort study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with painful osteoarthritis or unstable intra-articular PIP fractures who can communicate in Dutch.
Not a fit: Patients with inflammatory arthritis, poor bone quality, or those requiring revision surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes and reduced complications for patients undergoing PIP joint arthroplasty.
How similar studies have performed: While similar studies have explored joint arthroplasty, the specific use of the CapFlex PIP implant and its long-term fixation patterns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for PIP joint arthroplasty as described in the manufacturer's guideline, namely as a result of: * Painful osteoarthritis * Instable communitive intra-articular PIP fractures * Age \> 18 years * Patient is able to speak and write Dutch * Patient is willing to participate * Patient is able and willing to provide written informed consent Exclusion Criteria: * Inflammatory arthritis with significant bone loss * Insufficient bone quality to provide adequate stability * Known or suspected sensitivity or allergy to one or more of the implant materials * Revision surgery * Significant collateral instability * Pregnancy or breastfeeding
Where this trial is running
Zoetermeer, South Holland
- Reinier Haga Orthopedisch Centrum — Zoetermeer, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: N.M.C. Mathijssen
- Email: Onderzoek@rhoc.nl
- Phone: 079 - 206 5595
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.