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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00790-45 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SclerFIX-IP | Experimental | Treated, devitalised and sterile graft of umbilical cord amniotic membrane |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SclerFIX-IP | Biological | Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint |
| 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence BARNOUIN, MD | Contact | 4 72 68 69 09 | +33 | laurence.barnouin@tbf-lab.com |
| Justine BOSC, MSc | Contact | 4 72 68 69 11 | +33 | justine.bosc@tbf-lab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | 25030 | France |
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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 |
| Institut Chirurgical de la Main et du Membre Supérieur (ICMMS) | Recruiting | Lyon | 69006 | France |
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| Centre de la Main - Clinique Jules Verne | Recruiting | Nantes | 44300 | France |
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| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67200 | France |
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