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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
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This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondrocyte implantation | Experimental | From a previous biopsy, articular cartilage matrix is digested and chondrocytes are cultured in 2 passages until implants with at least 6,000,000 cells are constructed. These constructus of 8 mm in diameter are implanted arthroscopically by means of biodegradable anchor (MINILOK QUICKANCHOR TM from DePuy-Mitek ) located at the defect and tied securely. |
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| Microfractures | Experimental | Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matrix encapsulated chondrocyte implantation | Procedure | Each implant contains 6,000,000 autologous chondrocytes. |
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| Measure | Description | Time Frame |
|---|---|---|
| MRI T2 Mapping | Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation | Clinical assessment with validated knee scores, and adverse effects register are taken. | 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemente Ibarra, M.D. | INR | Principal Investigator |
| Luis G Ibarra, M.D. | INR | Study Chair |
| Enrique Villalobos, M.D. | INR | Study Director |
| Aldo F Izaguirre, M.D. M.Sc. | INR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Rehabilitation | Mexico City | 14389 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17681210 | Background | Masri M, Lombardero G, Velasquillo C, Martinez V, Neri R, Villegas H, Ibarra C. Matrix-encapsulation cell-seeding technique to prevent cell detachment during arthroscopic implantation of matrix-induced autologous chondrocytes. Arthroscopy. 2007 Aug;23(8):877-83. doi: 10.1016/j.arthro.2007.05.010. | |
| 19462773 | Background |
| Label | URL |
|---|---|
| Official site of the INR | View source |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Microfracture awl | Procedure | Is an awl that allow perforation of the subchondral bone. |
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| Ibarra-Ponce de Leon JC, Velasquillo-Martinez MC, Izaguirre A, Villalobos-Cordova E, Masri M, Ibarra-Ibarra LG. [Cartilage repair: cell-based techniques]. Acta Ortop Mex. 2009 Jan-Feb;23(1):38-44. Spanish. |
| 24746406 | Background | Ibarra C, Izaguirre A, Villalobos E, Masri M, Lombardero G, Martinez V, Velasquillo C, Meza AO, Guevara V, Ibarra LG. Follow-up of a new arthroscopic technique for implantation of matrix-encapsulated autologous chondrocytes in the knee. Arthroscopy. 2014 Jun;30(6):715-23. doi: 10.1016/j.arthro.2014.02.032. Epub 2014 Apr 18. |
| 34048286 | Derived | Ibarra C, Villalobos E, Madrazo-Ibarra A, Velasquillo C, Martinez-Lopez V, Izaguirre A, Olivos-Meza A, Cortes-Gonzalez S, Perez-Jimenez FJ, Vargas-Ramirez A, Franco-Sanchez G, Ibarra-Ibarra LG, Sierra-Suarez L, Almazan A, Ortega-Sanchez C, Trueba C, Martin FB, Arredondo-Valdes R, Chavez-Arias D. Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation Versus Microfracture: A 6-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2021 Jul;49(8):2165-2176. doi: 10.1177/03635465211010487. Epub 2021 May 28. |