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

NCT00719576 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-05-12

Study results available
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Summary

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.

Conditions

  • Articular Cartilage Defect

Interventions

BIOLOGICAL

autologous cultured chondrocytes on porcine collagen membrane

Implantation via mini-arthrotomy

PROCEDURE

Microfracture

Microfracture performed by arthroscopic surgery

Sponsors & Collaborators

  • Vericel Corporation

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Czechia
  • France
  • Netherlands
  • Norway
  • Poland
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00719576 on ClinicalTrials.gov