Status:
RECRUITING
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Osteoarthritis Hand
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment...
Eligibility Criteria
Inclusion
- Male or female; age between 18 and 75 years.
- Patient with symptomatic PIPJ OA.
- Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
- Patient with a QuickDash score \> 33 points (converted to 50%).
- Patient with pain, at rest, in the PIPJ ≥ 4/10 on a VAS.
- Patient who received the study information and provided consent.
- Member or beneficiary of a national health insurance plan.
Exclusion
- Pregnant or breastfeeding woman; woman without effective contraception.
- Patient with signs of neuropathy with functional disorders such as hyperesthesia.
- Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
- Person confined by a judicial or administrative decision.
- Adult subjected to legal protection measures or unable to provide his/her consent.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06034262
Start Date
October 7 2024
End Date
January 1 2026
Last Update
September 26 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Besançon
Besançon, France, 25030
2
Institut Chirurgical de la Main et du Membre Supérieur
Lyon, France, 69006
3
Centre de la Main - Clinique Jules Verne
Nantes, France, 44300