RecruitingRecruiting
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