Actively Recruiting
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
Led by Clinique Saint François, Nice, France · Updated on 2025-02-13
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on people with osteoarthritis affecting the finger or thumb joints, specifically the distal interphalangeal (DIP) joints, which can become painful and degenerated. The study aims to evaluate the time it takes for bone fusion during a finger joint arthrodesis surgery using the Kerifuse shape memory implant. This implant is being assessed because current methods like pins, screws, and staples, while effective, can have complications such as implant fractures, bone erosion, scarring, or nail problems. The treatment involves a surgical procedure where the Kerifuse implant is placed to stabilize the finger joint and promote fusion. The study will observe patients who undergo this arthrodesis surgery with the Kerifuse device. Researchers will monitor bone fusion progress and healing at multiple time points after surgery, ranging from day 5 up to 2 years. They will also assess the implant's position and effect radiologically, as well as hand function and patient satisfaction including cosmetic outcomes. Participants will be followed closely after surgery with evaluations at days 5, weeks 4, 6, 8, 10, 12, and continuing up to 2 years. Assessments include measuring bone fusion time, pain reduction, degree of joint arthritis, patient satisfaction, hand function, and radiological changes at the implant site. This thorough monitoring helps understand how well the Kerifuse implant supports healing and hand use over time. The study is sponsored by Clinique Saint François in France and lasts until September 2026.
CONDITIONS
Brief Title
Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus initial recovery period
Participants undergo arthrodesis of a finger distal interphalangeal joint using the KeriFuse implant.
1 surgery visit and initial post-operative care visits
Duration - Up to 2 years after surgery
Participants are monitored for bone fusion, pain relief, implant position, hand function, and patient satisfaction.
Visits at day 5; week 4; weeks 6, 8, 10, and 12; and year 2 after surgery
Trial Site Locations
Total: 1 location
1
Clinique Saint François
Nice, France, 06000
Actively Recruiting
Research Team
N
Nicolas DREANT, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here