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Trials / Recruiting

RecruitingNCT06546345

Post Market Clinical Follow-Up KeriFlex®

Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up

Status
Recruiting
Phase
Study type
Observational
Enrollment
86 (estimated)
Sponsor
Keri Medical SA · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not 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.

Conditions

Interventions

TypeNameDescription
DEVICEKeriFlex®The 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.

Timeline

Start date
2023-11-14
Primary completion
2026-07-01
Completion
2035-01-01
First posted
2024-08-09
Last updated
2025-09-11

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06546345. Inclusion in this directory is not an endorsement.

Post Market Clinical Follow-Up KeriFlex® (NCT06546345) · Clinical Trials Directory