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Post Market Clinical Follow-Up KeriFuse®

K

Keri Medical SA

Status

Enrolling

Conditions

Arthritis

Treatments

Device: KeriFuse®

Study type

Observational

Funder types

Industry

Identifiers

NCT06546332
2021-A03148-33

Details and patient eligibility

About

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.

Enrollment

97 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

7

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Central trial contact

CAUX

Data sourced from clinicaltrials.gov

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