Post Market Clinical Follow-Up KeriFuse®

September 4, 2025 updated by: Keri Medical SA

Effectiveness and Safety of the KeriFuse® Intramedullary Arthrodesis Implant and Associated Instruments in the Treatment of IP or DIP Arthritis: a Post Market Clinical Follow-up.

The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

97

Contacts and Locations

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

Study Locations

  • France
      • Aix-en-Provence, France, 13090
        • Centre de la main du Pays d'Aix
      • Beaumont, France, 63110
        • Clinique de la Chataigneraie
      • Bourgoin, France, 38300
        • Centre Ostéo Articulaire Fleming
      • Nice, France, 06000
        • Clinique Saint François
      • Perpignan, France, 66000
        • Clinique Mutualiste Catalane
      • Périgueux, France, 24000
        • Clinique du Parc

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

The intended target population for the KeriFuse® and associated instruments is an adult population requiring a surgical treatment claimed by the device and presenting bone quality deemed satisfactory by the surgeon.

Description

Inclusion Criteria:

  • Patients ≥ 18 years,
  • Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.

Exclusion Criteria:

  • Pregnant or nursing women,
  • Patients with intellectual disabilities who cannot follow the instructions of their surgeon,
  • Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®,
  • Patients with acute or chronic infections, local or systemic,
  • Patients with sensitivities or allergies to the implant components (Nickel, Titanium).

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
Pain and radiological assessment
Time Frame: 3 months
At 3 months postoperatively, the proportion of patients with a pain level ≤ 3 on VAS (ranking from 0 to 10 cm) and with a fused DIP or IP joint (radiological assessment)
3 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)

July 5, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2027

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

  • 2021-A03148-33

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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