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
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
65 Years

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.

Join this Trial

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Study Stats
Protocol No.
15-001628
Category
Orthopedic Surgery
Contact
DANA LEVIN
Location
  • UCLA Westwood
For Providers
NCT No.
NCT01957722
For detailed technical eligibility, visit ClinicalTrials.gov.