Evaluating the CapFlex PIP implant for osteoarthritis in the hand

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.