Post Market Clinical Follow-Up KeriFlex®

September 4, 2025 updated by: Keri Medical SA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25030
        • Recruiting
        • Chu Jean Minjoz
        • Contact:
          • OBERT
      • Lesquin, France, 59813
        • Recruiting
        • Clinic Lille Sud
        • Contact:
          • WAVREILLE
      • Pessac, France, 33600
        • Recruiting
        • Institut aquitain de la main et du membre supérieur
        • Contact:
          • ALET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any type of population requiring a surgical procedure covered by the device and presenting bone quality deemed satisfactory by the surgeon.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keri Medical SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01089-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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