Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Study Overview
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Brief Summary
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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.

Official Title
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Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.

Conditions
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Tear; Knee, Cartilage, Articular

Intervention / Treatment
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* Procedure: Matrix encapsulated chondrocyte implantation
* Procedure: Microfracture awl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2. Signed patient informed consent. Agree to adhere to rehabilitation protocol. Exclusion Criteria: Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations. Total meniscectomy Malalignment Evidence of osteoarthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chondrocyte implantation<br>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<br>* Each implant contains 6,000,000 autologous chondrocytes.<br>|
| Experimental: Microfractures<br>Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area. | Procedure: Microfracture awl<br>* Is an awl that allow perforation of the subchondral bone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI T2 Mapping | Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage, Articular