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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02916-33 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MENISC-T | Experimental | Segmented, devitalized and sterile meniscus graft |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MENISC-T | Biological | Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Chirurgical de la Main et du Membre Supérieur | Villeurbanne | 69100 | France |
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| 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 |