Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
Condition(s) studied
Investigational drug(s) / intervention(s)
with SclerFIX: Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
Study summary
The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis.
The main question this study aims to address is :
\- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function.
Participant will:
* Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0
* Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.
Eligibility
Primary outcome measure(s)
- Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. — Enrollment, 12 months
Thumb osteoarthritis-related pain will be assessed using the PRWE (Patient-Rated Wrist Evaluation) pain subscale and expressed as a percentage. The use of oral analgesics for hand pain will also be recorded at each follow-up visit, based on the preceding 7 days.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Chirurgical de la Main et du Membre Supérieur (ICMMS) | Lyon | France | Recruiting |
| Lyon Ortho Clinic - Centre de la Main - Clinqiue de la Sauvegarde | Lyon | France | Recruiting |
| Centre de la Main - Clinique Jules Verne | Nantes | France | Recruiting |
| ORTHOSUD Clinique Saint Jean Sud de France | Saint-Jean-de-Védas | France | Recruiting |
More TBF Genie Tissulaire trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07435571 on ClinicalTrials.gov ↗ ← All trials in France