Post Market Clinical Follow-Up KeriFlex®
Recruiting now
Conditions studied: Rheumatoid Arthritis, Degenerative Arthritis, Traumatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT06546345
- Run by
- Keri Medical SA
- People needed
- 86
- Starts
- 2023-11-14
- Expected to finish
- 2035-01-01
- Last updated by the study team
- 2025-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- CHU Jean Minjoz — Besançon, France (enrolling)
- Clinic Lille Sud — Lesquin, France (enrolling)
- Institut aquitain de la main et du membre supérieur — Pessac, France (enrolling)
Full record on ClinicalTrials.gov
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