Active — Not RecruitingNot Applicable

Post Market Clinical Follow-Up KeriFuse®

France97 participantsStarted 2022-07-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Pain and radiological assessment

Timeframe: 3 months

Trial details

NCT IDNCT06546332

SponsorKeri Medical SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12

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