Evaluating the KeriFuse® implant for arthritis surgery
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.
This study is testing how well and safely the KeriFuse® implant works for people having surgery for arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Keri Medical SA Industry-sponsored |
| Locations | 7 sites (Aix-en-Provence and 6 other locations) |
| Trial ID | NCT06546332 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance and safety of the KeriFuse® intramedullary arthrodesis implant used in surgeries for arthritis. It will evaluate the implant's effectiveness and safety over short and medium-term periods, following the approved labeling and instructions for use. The study will involve patients who are undergoing surgery with the KeriFuse® implant, collecting data on outcomes related to the implant's lifecycle.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for surgery using the KeriFuse® implant.
Not a fit: Patients who are pregnant, nursing, or have contraindications to surgery or the implant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of the KeriFuse® implant, potentially improving surgical outcomes for arthritis patients.
How similar studies have performed: While this study focuses on a specific implant, similar observational studies have shown success in evaluating the safety and performance of medical devices in surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Aix-en-Provence and 6 other locations
- Centre de la main du Pays d'Aix — Aix-en-Provence, France (Recruiting)
- Clinique de la Chataigneraie — Beaumont, France (Recruiting)
- Centre Ostéo Articulaire Fleming — Bourgoin-Jallieu, France (Recruiting)
- Clinique de la main — Caen, France (Withdrawn)
- Clinique Saint François — Nice, France (Recruiting)
- Clinique Mutualiste Catalane — Perpignan, France (Recruiting)
- Clinique du Parc — Périgueux, France (Recruiting)
Study contacts
- Study coordinator: Caux
- Email: clinic@kerimedical.com
- Phone: 058 255 01 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.