Open
Actively Recruiting
NOVOCART®3D for Treatment of Articular Cartilage of the Knee
About
Brief Summary
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
15-001628
Category
Musculoskeletal Disorders
Principal Investigator
Contact
Location
- UCLA Westwood