Health Trials

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

Locations

3
CHU Jean Minjoz25030, Besançon France
Clinic Lille Sud59813, Lesquin France
Institut aquitain de la main et du membre supérieur33600, Pessac France

Sponsors and collaborators

Keri Medical SA

Lead sponsor

Source ClinicalTrials.gov