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
This trial does not accept healthy volunteersQualifiers
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 population
Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
KeriFlex®
DeviceThe KeriFlex® finger joint prothesis MCP is designed to replace a damaged metacarpophalangeal (MCP) joint and the KeriFlex® finger joint prothesis PIP is designed to replace a damaged proximal interphalangeal (PIP) joint.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand
Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov