Post Market Clinical Follow-Up KeriFuse®

Last updated: August 6, 2024
Sponsor: Keri Medical SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

KeriFuse®

Clinical Study ID

NCT06546332
2021-A03148-33
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years,

  • Patients that will have a surgery using a KeriFuse® implant in accordance with theapproved labelling and IFU.

Exclusion

Exclusion Criteria:

  • Pregnant or nursing women,

  • Patients with intellectual disabilities who cannot follow the instructions of theirsurgeon,

  • Patients with a contraindication to surgery and more specifically to theimplantation of KeriFuse®,

  • Patients with acute or chronic infections, local or systemic,

  • Patients with sensitivities or allergies to the implant components (Nickel,Titanium).

Study Design

Total Participants: 97
Treatment Group(s): 1
Primary Treatment: KeriFuse®
Phase:
Study Start date:
July 05, 2022
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Centre de la main du Pays d'Aix

    Aix-en-Provence, 13090
    France

    Active - Recruiting

  • Clinique de la Chataigneraie

    Beaumont, 63110
    France

    Active - Recruiting

  • Centre Ostéo Articulaire Fleming

    Bourgoin-Jallieu, 38300
    France

    Active - Recruiting

  • Clinique de la main

    Caen, 14000
    France

    Site Not Available

  • Clinique Saint François

    Nice, 06000
    France

    Active - Recruiting

  • Clinique Mutualiste Catalane

    Perpignan, 66000
    France

    Active - Recruiting

  • Clinique du Parc

    Périgueux, 24000
    France

    Active - Recruiting

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