Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint 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 PIP joint osteoarthritis.

Eligibility criteria

Qualifiers

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%).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SclerFIX-IP

Treatment groups

14 Participants
are divided into 1 treatment group

Sponsors and collaborators