Follow-up of the KeriFlex silicone joint implant in finger arthritis
Checks how well and how safely the KeriFlex finger implant works in adults with arthritis.
Plain-language title generated from the registry record
Registry title: Post Market Clinical Follow-Up KeriFlex®
Key facts
- Where
- Besançon, Lesquin, and Pessac, FranceSee the 3 sites
Where in France
- Chu Jean MinjozBesançon, FranceTaking people
- Clinic Lille SudLesquin, FranceTaking people
- Institut aquitain de la main et du membre supérieurPessac, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Keri Medical SA
- Trial code
- NCT06546345
- Record updated
- 11 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant; Patients with acute or chronic, local or systemic infections; 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.