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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 PIP joint osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SclerFIX-IP | Experimental | Treated, devitalised and sterile graft of umbilical cord amniotic membrane |
|
| 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 PIPJ |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the symptomatology related to the PIPJ OA | Quality of life related to PIPJ 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 | No inflammatory reactions, no adverse events | Through study completion (12 months) |
| Change in pain related to PIPJ OA | Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS) |
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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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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 1 month, 3 months, 6 months, 12 months |
| Change in the treated finger mobility | Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study | 3 months, 6 months, 12 months |
| No apparent joint space anomaly | Joint space evaluated on radiography using Crosby's classification (stage 0 = no apparent anormaly; stage 1 = reduction to half of the normal joint space; stage 2 = hardly visible articular line; stage 3 = presence of erosions, scleroses and irregularity of the articular interline space) | 12 months |
| Institut Chirurgical de la Main et du Membre Supérieur | Recruiting | Lyon | 69006 | France |
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| Centre de la Main - Clinique Jules Verne | Recruiting | Nantes | 44300 | France |
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