Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee (SUMMIT)

Vericel

Status and phase

Completed

Phase 3

Conditions

Articular Cartilage Defect

Treatments

Procedure: Microfracture

Biological: autologous cultured chondrocytes on porcine collagen membrane

Study type

Interventional

Funder types

Industry

Identifiers

NCT00719576

MACI00206

2006-004817-16 (EudraCT Number)

Details and patient eligibility

About

The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

Full description

This is a prospective, randomized, open-label, parallel-group, multicenter study designed to investigate the outcome of MACI implant versus arthroscopic microfracture in the treatment of articular cartilage defects in the knee in patients between ages of 18 and 55 years.

All patients who meet the eligibility criteria and are considered suitable for inclusion will have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients will then be randomized during the index arthroscopy procedure to receive either MACI implant or microfracture treatment.

Patients randomized to treatment with MACI implant will return within approximately 4 to 8 weeks of the index arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Patients randomized to microfracture will undergo the procedure during the index arthroscopy.

Patients will be assessed post-arthroscopy and post-arthrotomy at intervals during 2 years follow-up. Evaluations include adverse events, functional and pain outcomes, arthroscopic and histologic evaluation and magnetic resonance imaging (MRI).

Enrollment

144 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement

Exclusion criteria

Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
Severe osteoarthritis of the knee
Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders
Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.