Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTBF Genie Tissulaire

About this trial

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.

Eligibility criteria

Qualifiers

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%).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SclerFIX-IP

Treatment groups

14 Participants
are divided into 1 treatment group

Sponsors and collaborators