Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Recruiting · NCT06038331 · Interventional (participants receive a specific treatment) · Lead sponsor: TBF Genie Tissulaire
View the official record on ClinicalTrials.gov →Interventions studied
SclerFIX-IP
What this trial is about
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 of STT osteoarthritis.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female; age between 18 and 75 years.
- Patient with symptomatic STT 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 wrist pain in front of the STT joint at rest = or \> 4/10 on VAS.
- Patient who received the study information and provided consent.
- Member or beneficiary of a national health insurance plan.
Exclusion criteria
- Pregnant or breastfeeding woman; woman without effective contraception.
- Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
- 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.
Where it is running
4 locations listed.
- CHU de Besançon - Besançon, France
- Institut Chirurgical de la Main et du Membre Supérieur (ICMMS) - Lyon, France
- Centre de la Main - Clinique Jules Verne - Nantes, France
- Hôpitaux Universitaires de Strasbourg - Strasbourg, France