Post Market Clinical Follow-Up KeriFlex®

Recruiting

• Conditions: Rheumatoid Arthritis; Degenerative Arthritis; Traumatic Arthritis

• Registration Number: NCT06546345
• Lead Sponsor: Keri Medical SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-14
• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-07
• Study Completion: 2035-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand	6 months	Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).

Trial Locations

Locations (3)

CHU Jean Minjoz; 🇫🇷 Besançon Cedex, France

Clinic Lille Sud; 🇫🇷 Lesquin Cedex, France

Institut aquitain de la main et du membre supérieur; 🇫🇷 Pessac, France