Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

Phase 3

Completed

• Conditions: Tear; Knee, Cartilage, Articular
• Interventions: Procedure: Microfracture awl; Procedure: Matrix encapsulated chondrocyte implantation

• Registration Number: NCT01947374
• Lead Sponsor: Instituto Nacional de Rehabilitacion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfractures	Microfracture awl	Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.
Chondrocyte implantation	Matrix encapsulated chondrocyte implantation	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.

Primary Outcome Measures

Name	Time	Method
MRI T2 Mapping	24 months	Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation	0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months	Clinical assessment with validated knee scores, and adverse effects register are taken.

Trial Locations

Locations (1)

National Institute of Rehabilitation; 🇲🇽 Mexico City, Mexico