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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Each implant contains 6,000,000 autologous chondrocytes.
Is an awl that allow perforation of the subchondral bone.
National Institute of Rehabilitation
Mexico City, Mexico
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
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