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Post Market Clinical Follow-Up KeriFlex®

RECRUITINGSponsored by Keri Medical SA
Actively Recruiting
SponsorKeri Medical SA
Started2023-11-14
Est. completion2026-07
Eligibility
Age18 Years+
Healthy vol.Accepted

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 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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

ArthritisDegenerative ArthritisRheumatoid ArthritisTraumatic Arthritis

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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