Post Market Clinical Follow-Up KeriFuse®

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).