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

Phase 2

Recruiting

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

• Registration Number: NCT06034262
• 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 PIP joint osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Status Verified: 2024-11
• Study Start: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• 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 PIPJ 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 pain, at rest, in the PIPJ ≥ 4/10 on a 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 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
Change in the symptomatology related to the PIPJ OA	12 months	Quality of life related to PIPJ 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
Absence of toxicity	Through study completion (12 months)	No inflammatory reactions, no adverse events
Change in the treated finger mobility	3 months, 6 months, 12 months	Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study
Change in pain related to PIPJ 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)
No apparent joint space anomaly	12 months	Joint space evaluated on radiography using Crosby's classification (stage 0 = no apparent anormaly; stage 1 = reduction to half of the normal joint space; stage 2 = hardly visible articular line; stage 3 = presence of erosions, scleroses and irregularity of the articular interline space)

Trial Locations

Locations (3)

CHU de Besançon; 🇫🇷 Besançon, France

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

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