Status:
RECRUITING
Post Market Clinical Follow-Up KeriFlex®
Lead Sponsor:
Keri Medical SA
Conditions:
Rheumatoid Arthritis
Degenerative Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 instruction...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2035
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06546345
Start Date
November 14 2023
End Date
January 1 2035
Last Update
September 11 2025
Active Locations (3)
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1
CHU Jean Minjoz
Besançon, France, 25030
2
Clinic Lille Sud
Lesquin, France, 59813
3
Institut aquitain de la main et du membre supérieur
Pessac, France, 33600