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


Sponsor

Keri Medical SA

Enrollment

86 participants

Start Date

Nov 14, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a post-market follow-up study monitoring the long-term safety and performance of the KeriFlex® joint implant used in finger joint replacement surgery (metacarpophalangeal or proximal interphalangeal joints). **You may be eligible if...** - You are 18 or older - You are about to have a finger joint replacement using a KeriFlex® implant - You have rheumatoid arthritis, osteoarthritis, or post-traumatic osteoarthritis affecting the finger joints **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active local or systemic infection - Your bone quality or muscle condition is insufficient for the implant to work properly - You have a medical reason that prevents surgery - You have an intellectual disability preventing you from following post-surgical instructions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.


Locations(3)

CHU Jean Minjoz

Besançon, France

Clinic Lille Sud

Lesquin, France

Institut aquitain de la main et du membre supérieur

Pessac, France

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NCT06546345


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