Post Market Clinical Follow-Up KeriFlex®

Launched by KERI MEDICAL SA · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the KeriFlex® joint implant, which is designed to help patients with conditions like rheumatoid arthritis, degenerative arthritis, and traumatic arthritis. The main goal is to see how well the implant works and how safe it is over both short and long periods of time. The researchers want to make sure that the implant performs as expected and doesn’t cause any problems when used according to the instructions provided.

To be eligible for this study, participants need to be adults aged 18 or older who are planning to have surgery to replace specific finger joints using the KeriFlex® implant. However, there are some people who cannot participate, such as pregnant or breastfeeding women and those with certain health issues that could complicate the surgery. If you join this trial, you can expect to receive the KeriFlex® implant and be monitored for your progress after the surgery to help ensure it is effective and safe. This study is currently looking for volunteers, and both men and women are welcome to participate.

Gender

ALL

Eligibility criteria

• 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