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

Recruiting now · Phase 2

Conditions studied: Osteoarthritis Hand

In brief

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.

Key facts

Study ID

NCT06034262

Run by

TBF Genie Tissulaire

People needed

14

Starts

2024-10-07

Expected to finish

2026-01-01

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%).
• Patient with pain, at rest, in the PIPJ ≥ 4/10 on a VAS.
• Patient who received the study information and provided consent.
• Member or beneficiary of a national health insurance plan.

You may not qualify if…

• 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.
• Adult subjected to legal protection measures or unable to provide his/her consent.

Where it is running

• CHU de Besançon — Besançon, France (enrolling)
• Institut Chirurgical de la Main et du Membre Supérieur — Lyon, France (enrolling)
• Centre de la Main - Clinique Jules Verne — Nantes, France (enrolling)

Full record on ClinicalTrials.gov

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