Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Instituto Nacional de Rehabilitacion

Status and phase: Completed; Phase 3

Conditions: Tear; Knee, Cartilage, Articular

Treatments: Procedure: Matrix encapsulated chondrocyte implantation; Procedure: Microfracture awl

Study type: Interventional

Funder types: Other

Identifiers

NCT01947374

017-05-INR

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Chondrocyte implantation

Experimental group

Description:

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.

Treatment:

Procedure: Matrix encapsulated chondrocyte implantation

Microfractures

Experimental group

Description:

Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.

Treatment:

Procedure: Microfracture awl