Actively Recruiting
Evaluation of Treated, Devitalized, Sterile Umbilical Cord Amniotic Membrane Implant in Symptomatic PIP Joint Osteoarthritis
Led by TBF Genie Tissulaire · Updated on 2025-09-26
14
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of a sterile, treated, devitalized umbilical cord amniotic membrane implant to treat symptomatic proximal interphalangeal joint osteoarthritis (PIPJ OA) of the hand. This open, prospective, multicenter phase 2 trial aims to evaluate how this implant affects symptoms and joint function in adults aged 18 to 75 who have persistent pain and functional impairment despite medical treatment. The study is sponsored by TBF Genie Tissulaire. Participants will receive the treated and sterile umbilical cord amniotic membrane graft, called SclerFIX-IP, placed as an interposition implant in the affected PIP joint. This biological treatment involves a decellularized, viro-inactivated, freeze-dried graft designed to be implanted surgically. The trial does not include a comparison group or masking and will assess outcomes over a 12-month period. During the study, participants will be monitored for changes in PIP joint symptoms, pain levels at multiple time points (1, 3, 6, and 12 months), finger mobility, and any joint space abnormalities. Safety will be assessed throughout with attention to toxicity. The primary outcome is symptom change at 12 months. Participants must provide consent and be members or beneficiaries of a national health insurance plan. The total participation duration covers at least 12 months of follow-up.
CONDITIONS
Brief Title
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years
- Symptomatic proximal interphalangeal joint osteoarthritis
- Medical treatment for functional signs for more than 3 months without improvement, justifying surgical intervention
- QuickDash score greater than 33 points (converted to 50%)
- Pain at rest in the PIP joint of 4 or higher on a 10-point scale
- Provided informed consent after receiving study information
- Member or beneficiary of a national health insurance plan
You will not qualify if you...
- Pregnant or breastfeeding women; women without effective contraception
- Signs of neuropathy with functional disorders such as hyperesthesia
- Uncontrolled epilepsy or neuropathy contraindicating locoregional anesthesia
- Person confined by a judicial or administrative decision
- Adult under legal protection measures or unable to provide consent
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 - Single intervention with follow-up assessments over 12 months
Participants receive a treated, devitalized, sterile umbilical cord amniotic membrane implant in the proximal interphalangeal joint to treat osteoarthritis.
Visits at 1 month, 3 months, 6 months, and 12 months post-treatment
Trial Site Locations
Total: 3 locations
1
CHU de Besançon
Besançon, France, 25030
Actively Recruiting
2
Institut Chirurgical de la Main et du Membre Supérieur
Lyon, France, 69006
Actively Recruiting
3
Centre de la Main - Clinique Jules Verne
Nantes, France, 44300
Actively Recruiting
Research Team
L
Laurence BARNOUIN, MD
J
Justine BOSC, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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