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

TBF Genie Tissulaire

Status and phase

Enrolling

Phase 2

Conditions

Osteoarthritis Hand

Treatments

Biological: SclerFIX-IP

Study type

Interventional

Funder types

Industry

Identifiers

NCT06038331

SclerFIX-STT-TBF

2023-A00790-45 (Other Identifier)

Details and patient eligibility

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 STT osteoarthritis.

Enrollment

14 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.