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| ID | Type | Description | Link |
|---|---|---|---|
| RB 06.031 |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Autologous chondrocytes transplantation |
|
| 2 | Active Comparator | Mosaicoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous chondrocytes transplantation | Procedure | Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation scoring system | IKDC |
| Measure | Description | Time Frame |
|---|---|---|
| MRI | at 2 years | |
| Arthroscopy with biopsy | at 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F DUBRANA, PhD MD | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lyon | Lyon | Lyon | 69300 | France | ||
| Orthopaedic surgery Departement Brest University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26742454 | Result | Clave A, Potel JF, Servien E, Neyret P, Dubrana F, Stindel E. Third-generation autologous chondrocyte implantation versus mosaicplasty for knee cartilage injury: 2-year randomized trial. J Orthop Res. 2016 Apr;34(4):658-65. doi: 10.1002/jor.23152. Epub 2016 Jan 18. |
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| Mosaicoplasty | Procedure | Osteochondral patch are sampled and then implanted during the same surgical procedure |
|
| Brest |
| 29200 |
| France |
| CHU de Caen | Caen | 14 033 | France |
| Centre médico chirurgical de Dracy-Le-Fort | Dracy-le-Fort | 71 640 | France |
| CHU de Grenoble | Grenoble | 38 042 | France |
| Ch Versailles | Le Chesnay | 78 150 | France |
| Clinique Chenieux | Limoges | 87 000 | France |
| CH Nord Mayenne | Mayenne | 53 103 | France |
| CHU de Nancy | Nancy | 54 035 | France |
| HIA Bégin | Saint-Mandé | 94 160 | France |
| CHU de Strasbourg | Strasbourg | 67 400 | France |
| Clinique du cours Dillon | Toulouse | France |