Surgery to fuse finger joints using the Kerifuse device
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
This study is testing a new device to see if it helps fuse finger joints in people with osteoarthritis faster and better than current methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Saint François, Nice, France Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT06151834 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Kerifuse shape memory implant in performing arthrodesis on the distal interphalangeal joints of fingers affected by osteoarthritis. The primary focus is on measuring the time it takes for bone fusion to occur after the procedure. Secondary objectives include assessing the fusion rate, patient satisfaction, overall hand function, and the radiological evolution of the implant and arthrodesis angle. The study aims to provide insights into the benefits and potential complications associated with this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates are patients suffering from osteoarthritis of the finger who require interphalangeal arthrodesis.
Not a fit: Patients who are pregnant, have intellectual disabilities, or have contraindications to surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide reliable pain relief and improved joint function for patients with osteoarthritis in their fingers.
How similar studies have performed: While various stabilization methods have been used in similar procedures, the specific use of the Kerifuse device in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant Exclusion Criteria: * Pregnant or breastfeeding patient * Patient with an intellectual disability and who therefore cannot follow the surgeon's instructions * Patients with contraindications to surgery * Patients with acute or chronic, local or systemic infections * Patients with sensitivities or allergies to device components (Nickel, Titanium)
Where this trial is running
Nice
- Clinique Saint François — Nice, France (Recruiting)
Study contacts
- Study coordinator: Nicolas DREANT, MD
- Email: nicolas.dreant@sfr.fr
- Phone: +334 93 13 68 31
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.