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

Study Overview
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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.

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

Conditions
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Osteoarthritis Hand

Intervention / Treatment
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* Biological: SclerFIX-IP


Participation Criteria
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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.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 STT joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of the symptomatology related to the STT OA | 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 | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)