Actively Recruiting
Evaluation of a Sterile Umbilical Cord Amniotic Membrane Implant for Symptomatic Scaphotrapeziotrapezoidal Osteoarthritis
Led by TBF Genie Tissulaire · Updated on 2025-09-30
14
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a sterile, processed umbilical cord amniotic membrane implant to treat scaphotrapeziotrapezoidal (STT) osteoarthritis, a condition causing joint pain and dysfunction in the hand. This open, prospective, multicenter trial aims to assess the implant's effect on reducing symptoms related to STT osteoarthritis over one year. The study is sponsored by TBF Genie Tissulaire and takes place within a Phase 2 clinical research framework. Participants receive the SclerFIX-IP implant, which is a decellularized, viro-inactivated, freeze-dried, sterile graft made from the amniotic membrane of the umbilical cord. This graft is placed in joint interposition at the STT joint to potentially improve joint function and reduce pain. The treatment is delivered as a surgical implant. There is no masking or blinding involved in this study. During the 12-month follow-up, participants will be monitored for symptom improvement, including pain reduction, functional activity improvement involving the thumb, and increased thumb and grip strength. Researchers will also assess the absence of inflammatory reactions and the implant's local tolerance. Safety is evaluated by checking for any joint space anomalies. Participants will have regular assessments at 1, 3, 6, and 12 months to track these outcomes.
CONDITIONS
Brief Title
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years
- Patient with symptomatic STT osteoarthritis
- Patient treated medically for functional symptoms for more than 3 months without improvement
- QuickDash score greater than 33 points (converted to 50%)
- Wrist pain in front of the STT joint at rest rated 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 or women without effective contraception
- Patient with functional rhizarthrosis not stabilized or treated medically or surgically
- Patient with signs of neuropathy causing functional disorders such as hyperesthesia
- Patient with uncontrolled epilepsy or neuropathy contraindicating locoregional anesthesia
- Person confined by judicial or administrative decision
- Adult under legal protection or unable to provide consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive an implant of a treated, devitalized, and sterile umbilical cord amniotic membrane in the scaphotrapeziotrapezoidal joint to treat osteoarthritis symptoms.
Visits at 1 month, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 4 locations
1
CHU de Besançon
Besançon, France, 25030
Actively Recruiting
2
Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)
Lyon, France, 69006
Actively Recruiting
3
Centre de la Main - Clinique Jules Verne
Nantes, France, 44300
Actively Recruiting
4
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67200
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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