A Phase 3 interventional study of Matrix encapsulated chondrocyte implantation and Microfracture awl in Tear; Knee, Cartilage, Articular, sponsored by Instituto Nacional de Rehabilitacion. Completed at 1 site in Mexico. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Instituto Nacional de Rehabilitacion · Phase 3, Interventional, and Treatment
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.
168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.
This study's enrollment of 48 is below the median of 66 across 134 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →Instituto Nacional de Rehabilitacion is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Matrix encapsulated chondrocyte implantation
Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.
Procedure: Microfracture awl
Each implant contains 6,000,000 autologous chondrocytes.
Is an awl that allow perforation of the subchondral bone.
MRI T2 Mapping
Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.
Time frame: 24 months
Clinical evaluation
Clinical assessment with validated knee scores, and adverse effects register are taken.
Time frame: 0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Rehabilitacion