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Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
Sponsor: TBF Genie Tissulaire
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.
Official title: Evaluation of the Treatment of Trapeziometacarpal Osteoarthritis (TMC OA) With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2026-11
Completion Date
2028-03
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
with SclerFIX
Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
Locations (4)
Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)
Lyon, France
Lyon Ortho Clinic - Centre de la Main - Clinqiue de la Sauvegarde
Lyon, France
Centre de la Main - Clinique Jules Verne
Nantes, France
ORTHOSUD Clinique Saint Jean Sud de France
Saint-Jean-de-Védas, France