Post Market Clinical Follow-Up KeriFuse®
Effectiveness and Safety of the KeriFuse® Intramedullary Arthrodesis Implant and Associated Instruments in the Treatment of IP or DIP Arthritis: a Post Market Clinical Follow-up.
1 other identifier
observational
97
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedSeptember 11, 2025
September 1, 2025
3.4 years
August 6, 2024
September 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pain and radiological assessment
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)
3 months
Interventions
The intramedullary arthrodesis Implant (KeriFuse®) is indicated for consolidation or bone fusion (arthrodesis) of degraded or arthritic distal interphalangeal (DIP) of hand digits or interphalangeal (IP) joint of the hand thumb.
Eligibility Criteria
The intended target population for the KeriFuse® and associated instruments is an adult population requiring a surgical treatment claimed by the device and presenting bone quality deemed satisfactory by the surgeon.
You may qualify if:
- Patients ≥ 18 years,
- Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Keri Medical SAlead
Study Sites (6)
Centre de la main du Pays d'Aix
Aix-en-Provence, 13090, France
Clinique de la Chataigneraie
Beaumont, 63110, France
Centre Ostéo Articulaire Fleming
Bourgoin, 38300, France
Clinique Saint François
Nice, 06000, France
Clinique Mutualiste Catalane
Perpignan, 66000, France
Clinique du Parc
Périgueux, 24000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 9, 2024
Study Start
July 5, 2022
Primary Completion
December 1, 2025
Study Completion (Estimated)
March 1, 2027
Last Updated
September 11, 2025
Record last verified: 2025-09