An Extension Protocol for Participants of Genzyme-Sponsored;Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous Chondrocyte Implantation (MACI® implant) for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea
Phase 3
Completed
- Conditions
- Cartilage defect kneeknee injury10023213
- Registration Number
- NL-OMON36244
- Lead Sponsor
- Genzyme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
Inclusion Criteria
Patients must meet the following criteria to participate in this extension study:;1. Received study treatment (MACI implant or microfracture) in the MACI00206 study.;2. Provides written informed consent.
Exclusion Criteria
Exclusion Criteria, not applicable for this extension study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from MACI00206 Baseline to Week 156 for the patient*s Knee Injury and<br /><br>Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational<br /><br>activities) scores.</p><br>
- Secondary Outcome Measures
Name Time Method