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Recruiting

Post Market Clinical Follow-Up KeriFlex®

NCT06546345 · Keri Medical SA
In plain English

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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
About this study
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.
Eligibility 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
Study design
Enrollment target: 86 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-14
Estimated completion: 2035-01
Last updated: 2025-09-11
Interventions
Device: KeriFlex®
Primary outcomes
  • Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand (6 months)
Sponsor
Keri Medical SA · industry
Contacts & investigators
ContactCAUX · contact · clinic@kerimedical.com · 058 255 01 30
All locations (3)
CHU Jean MinjozRecruiting
Besançon, France
Clinic Lille SudRecruiting
Lesquin, France
Institut aquitain de la main et du membre supérieurRecruiting
Pessac, France
Post Market Clinical Follow-Up KeriFlex® · TrialPath