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CapFlex PIP Implant RSA

Recruitingn/aAges 18 Years - anyAllReinier Haga Orthopedisch Centrum
NCT05484089 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. To reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. By using model-based roentgen stereogrammaetric analysis (mRSA), the migration pattern of the implant over time can be calculated. Objective: The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (produced and developed by several companies of KLS Martin Group) in vivo, using mRSA, over 10 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the CapFlex PIP implant system. Study

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📋 Eligibility rules (as published)
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
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What it tests

  • CapFlex PIP implant
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Where

1 site
Reinier Haga Orthopedisch Centrum
Zoetermeer, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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