NCT01947374

Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Instituto Nacional de Rehabilitacion · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tear; Knee, Cartilage, Articular

Interventions

Type	Name	Description
PROCEDURE	Matrix encapsulated chondrocyte implantation	Each implant contains 6,000,000 autologous chondrocytes.
PROCEDURE	Microfracture awl	Is an awl that allow perforation of the subchondral bone.

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-09-20
• Last updated: 2017-04-12

Locations

1 site across 1 country: Mexico