Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus 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 Meniscus Segment (MENISC-T) Placed in Joint Interposition

Conditions
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Osteoarthritis Hand

Intervention / Treatment
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* Biological: MENISC-T


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 (VAS) in front of the STT joint at rest > 4/10. 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: MENISC-T<br>Segmented, devitalized and sterile meniscus graft | Biological: MENISC-T<br>* Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at 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 toxicity | Absence of adverse events | Through study completion - average of 12 months | 
| Increase of thumb strength | Thumb strength measured in kg by two-point pinch strength test | 1 month, 3 months, 6 months, 12 months | 
| Decrease of pain related to STT OA | Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) | 1 month, 3 months, 6 months, 12 months | 
| No apparent anomaly of joint space | 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)