Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MENISC-T Segmented, devitalized and sterile meniscus graft |
Biological: MENISC-T
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint
|
Outcome Measures
Primary Outcome Measures
- 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
- Absence of toxicity [Through study completion - average of 12 months]
Absence of adverse events
- Increase of thumb strength [1 month, 3 months, 6 months, 12 months]
Thumb strength measured in kg by two-point pinch strength test
- 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 visual analog scale (VAS)
- No apparent anomaly of joint space [12 months]
Joint space evaluated on radiography using Crosby's classification
Eligibility Criteria
Criteria
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.
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Patient with a QuickDash score > 33 points (converted to 50%).
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Patient with wrist pain (VAS) in front of the STT joint at rest > 4/10.
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Patient who received the study information and provided consent.
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Member or beneficiary of a national health insurance plan.
Exclusion Criteria:
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Pregnant or breastfeeding woman; woman without effective contraception.
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Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
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Patient with signs of neuropathy with functional disorders such as hyperesthesia.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Chirurgical de la Main et du Membre Supérieur | Villeurbanne | France | 69100 |
Sponsors and Collaborators
- TBF Genie Tissulaire
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MENISC-T-STT
- 2020-A02916-33