Assessing the KeriFlex® silicone joint implant for arthritis treatment
Official title: Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up
Run by Keri Medical SA · NCT06546345 · Data updated 2026-11-12
This study is testing how well the KeriFlex® silicone joint implant works and is safe for people with different types of arthritis who are getting joint replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Keri Medical SA Industry-sponsored |
| Locations | 3 sites (Besançon and 2 other locations) |
| Status | Recruiting |
| Started | November 14, 2023 |
| Main results expected | July 2026 |
| Study ends | January 2035 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT06546345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are scheduled for arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant.
✕Probably not a fit
Patients who are pregnant, have significant physical activity involving the treated joint, or have contraindications to surgery will not benefit from this study.
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 evaluate the performance and safety of the KeriFlex® silicone joint implant used in arthroplasty for patients with rheumatoid arthritis, degenerative arthritis, or traumatic arthritis. The study will monitor both short-term and long-term outcomes related to the implant's lifecycle, ensuring adherence to the manufacturer's instructions. By collecting data from patients undergoing this procedure, the study seeks to provide insights into the effectiveness and safety of the KeriFlex® implant.
Why it matters
Potential benefit: If successful, this study could enhance treatment options for patients with arthritis by providing a safer and more effective joint implant.
How similar studies have gone: While this study focuses on a specific implant, similar observational studies have shown success in evaluating joint implants, suggesting a potential for valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU Jean Minjoz
Besançon, France Recruiting -
Clinic Lille Sud
Lesquin, France Recruiting -
Institut aquitain de la main et du membre supérieur
Pessac, France Recruiting
Study contacts
- Study coordinator: Caux
- Email: clinic@kerimedical.com
- Phone: 058 255 01 30
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.