Status:
COMPLETED
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
Lead Sponsor:
Vericel Corporation
Conditions:
Articular Cartilage Defect
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief 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 articula...
Detailed 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 car...
Eligibility Criteria
Inclusion
- Symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00719576
Start Date
July 1 2008
End Date
March 1 2012
Last Update
May 12 2021
Active Locations (20)
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1
Urazova nemocnice v Brne
Brno, Czechia
2
Fakultni Nemocnice Na Bulovce
Prague, Czechia
3
Fakultni Nemocnice v Motole
Prague, Czechia
4
Hopital d'instruction des armees Robert Picque
Bordeaux, France