RecruitingPhase 2NCT06038331

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

Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition

Sponsor

TBF Genie Tissulaire

Enrollment

14 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis Hand

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria6

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.

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Interventions

BIOLOGICALSclerFIX-IP

Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint

Locations(4)

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

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NCT06038331

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