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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Treatment of Symptomatic Proximal InterPhalangeal (PIP) Joint Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition

Conditions
-----------------
Osteoarthritis Hand

Intervention / Treatment
-----------------
* Biological: SclerFIX-IP


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SclerFIX-IP<br>Treated, devitalised and sterile graft of umbilical cord amniotic membrane | Biological: SclerFIX-IP<br>* Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the symptomatology related to the PIPJ OA | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of toxicity | No inflammatory reactions, no adverse events | Through study completion (12 months) | 
| Change in pain related to PIPJ OA | Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS) | 1 month, 3 months, 6 months, 12 months | 
| Change in the treated finger mobility | Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study | 3 months, 6 months, 12 months | 
| No apparent joint space anomaly | 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) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proximal InterPhalangeal Joint (PIPJ), OsteoArthritis (OA)