The enrollment is in progress for an FDA phase 3 clinical trial in San Diego, California studying the ability to heal cartilage, or joint surface, injuries and eliminate pain. Dr. Hacker serves as Principal Investigator for this study of a investigational device in the Southern California region, offering a new approach to heal damage to a joint surface once thought to be impossible.
For more information, please go to www.neocartimplant.com. To see if this may be something that you would qualify for, contact Dr. Hacker’s office directly at email@example.com or call 619-354-7060 and select option 2.
What is NeoCart ?
NeoCart is a three-dimensional scaffold grown from a small biopsy of your own healthy cartilage. It is implanted in a second surgery approximately 6-8 weeks later. The purpose of this study is to compare the efficacy of NeoCart and Microfracture, the current standard of care for full-thickness cartilage injury to the knee. Patients are randomized to NeoCart or Microfracture treatment (2:1). This is a multi-center Clinical Trial. The following is a summary of study inclusion and exclusion criteria.
18-55 years of age
Symptomatic knee pain
Full-thickness articular cartilage injury of the femur that would be treatable by microfracture
Medically able to undergo MRIs and knee surgery
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Cartilage injury with substantial bone loss
Cartilage injury larger than the NeoCart patch
Any previous surgical treatment other than chondroplasty/debridement of the study cartilage defect
Symptomatic condition of the other knee
Surgery on the other knee within 3 months of the study surgery
Painful conditions of the hip and lower back that would interfere with knee evaluation
Body Mass Index > 35 kg/m2
Pregnancy or intended pregnancy during the year following treatment
Any autoimmune disease
Ligement reconstruction within 3 months of study surgery
Frequent use of cigarettes or tobacco products
Current drug or alcohol abuse
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