NCT06546345Recruiting
Post Market Clinical Follow-Up KeriFlex®
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 86 (estimated)
- First submitted
- 6 Aug 2024
- Start date
- 14 Nov 2023
- Primary completion date
- Jul 2026
- Lead sponsor
- Keri Medical SA
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06546345
What you commit to
- Study type: Observational
- Planned participants: 86
- From 14 Nov 2023 to the primary completion date, Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant
Other illness
- Patients with acute or chronic, local or systemic infections
Other
- Pregnant or breastfeeding women
- Patients with an intellectual disability who cannot follow their surgeon's instructions
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Clinic Lille Sud Coordinator of this site? Confirm its status | Lesquin | France | Recruiting |
| Institut aquitain de la main et du membre supérieur Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.