Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06034262

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

Led by TBF Genie Tissulaire · Updated on 2025-09-26

14

Participants Needed

3

Research Sites

64 weeks

Total Duration

On this page

AI-Summary

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 PIP joint osteoarthritis.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged between 18 and 75 years
  • Have symptomatic proximal interphalangeal joint osteoarthritis
  • Have tried medical treatment for symptoms for more than 3 months without improvement, requiring surgery
  • Have a QuickDash score greater than 33 points (converted to 50%)
  • Experience pain at rest in the PIP joint of 4 or higher on a 0 to 10 pain scale
  • Have received study information and provided consent
  • Be a member or beneficiary of a national health insurance plan
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding woman, or woman not using effective contraception
  • Have signs of neuropathy with functional disorders such as hyperesthesia
  • Have uncontrolled epilepsy or neuropathy that prevents locoregional anesthesia
  • Be confined by judicial or administrative decision
  • Be an adult under legal protection measures or unable to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

CHU de Besançon

Besançon, France, 25030

Actively Recruiting

2

Institut Chirurgical de la Main et du Membre Supérieur

Lyon, France, 69006

Actively Recruiting

3

Centre de la Main - Clinique Jules Verne

Nantes, France, 44300

Actively Recruiting

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Research Team

L

Laurence BARNOUIN, MD

CONTACT

J

Justine BOSC, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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