Post Market Clinical Follow-Up KeriFuse®
- Conditions
- Arthritis
- Registration Number
- NCT06546332
- Lead Sponsor
- Keri Medical SA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 97
- Patients ≥ 18 years,
- Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain and radiological assessment 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Centre de la main du Pays d'Aix
🇫🇷Aix-en-Provence, France
Clinique de la main
🇫🇷Caen, France
Centre Ostéo Articulaire Fleming
🇫🇷Bourgoin-Jallieu, France
Clinique de la Chataigneraie
🇫🇷Beaumont, France
Clinique Mutualiste Catalane
🇫🇷Perpignan, France
Clinique du Parc
🇫🇷Périgueux, France
Clinique Saint François
🇫🇷Nice, France