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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis Hand

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SclerFIX-IP

Treated, devitalised and sterile graft of umbilical cord amniotic membrane

Group Type EXPERIMENTAL

SclerFIX-IP

Intervention Type BIOLOGICAL

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

Interventions

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SclerFIX-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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No