Post Market Clinical Follow-Up KeriFlex®
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKeri Medical SA
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- KeriFlex®
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov