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

Phase 2

Recruiting

• Conditions: Osteoarthritis Hand
• Interventions: Biological: SclerFIX-IP

• Registration Number: NCT06038331
• Lead Sponsor: TBF Genie Tissulaire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-14
• Study Start: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SclerFIX-IP	SclerFIX-IP	Treated, devitalised and sterile graft of umbilical cord amniotic membrane

Primary Outcome Measures

Name	Time	Method
Decrease of the symptomatology related to the STT OA	12 months	Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit

Secondary Outcome Measures

Name	Time	Method
Improvement of functional activities involving the thumb	1 month, 3 months, 6 months, 12 months	Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
No apparent joint space anomaly	12 months	Joint space evaluated on radiography using Crosby's classification
Increase of thumb strength	3 months, 6 months, 12 months	Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Decrease of pain related to STT OA	1 month, 3 months, 6 months, 12 months	Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Absence of inflammatory reactions and good local tolerance of the implant	Through study completion (12 months)	No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
Increase of grip strength	3 months, 6 months, 12 months	Grip strength measured in kg by grip strength test using a dynamometer

Trial Locations

Locations (3)

Centre de la Main - Clinique Jules Verne; 🇫🇷 Nantes, France

Institut Chirurgical de la Main et du Membre Supérieur (ICMMS); 🇫🇷 Lyon, France

CHU de Besançon; 🇫🇷 Besançon, France