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Post Market Clinical Follow-Up KeriFlex®

Recruitingn/aAges 18 Years - anyAllKeri Medical SA
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In plain words

What the trial is, and whether it could suit you

The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force. The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients (age ≥ 18 years) * Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force. * Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis Exclusion Criteria: * Pregnant or breastfeeding women * Patients with an intellectual disability who cannot follow their surgeon's instructions * Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant * Patients with acute or chronic, local or systemic infections * Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation * Muscle loss, alteration or vascular deficiency in the affected finger * Patients with significant physical activity involving treated joint * Children, young growing patients with open epiphyses
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What it tests

  • KeriFlex®
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Where

3 sites
CHU Jean Minjoz
Besançon, France
Clinic Lille Sud
Lesquin, France
Institut aquitain de la main et du membre supérieur
Pessac, France
🤝 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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