A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects

AAG-G-H-1220

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

2013-12-01

2025-12-01

2027-12-01

Active (not recruiting)

Early phase I

233

Inclusion Criteria: * Greater than 18 years old * Isolated articular cartilage lesions on the femoral condyle 2-6 cm2 * Minimum score on the KOOS questionnaire Exclusion Criteria: * Instability of the knee joint * Arthritis * Autoimmune disease * Immune suppression * Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline) * Bone disease * Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 233, 'type': 'ACTUAL'}}

2024-05-13