Clinical Trial TitleA Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared to Microfracture in the Treatment of Articular Cartilage Defects
National Clinical Trial Number:NCT01957722
Clinical Trial Protocol Description:
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. NOVOCART 3D is an autologous chondrocyte implant system, meaning that the patient's own cartilage is harvested and cultivated to produce the implant. Microfracture, the other procedure, is a current standard of care for cartilage knee defects. It is performed by making small holes in the bone at the bottom of the cartilage defect to cause bleeding and a clot. The clot then repairs the cartilage that fills the cartilage defect.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 to 65 years of age.
- Have an isolated articular cartilage lesion on the femoral condyle that is 2.0-6.0 cm2.
- Have a minimum score on the KOOS questionnaire.
You will be excluded from the study if any of the following criteria apply to you:
- Have an instability of the knee joint.
- Have significant arthritis (Rheumatoid, metabolic, or infectious).
- Have had a prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline).
- Have any degenerative muscular, connective tissue or neurological condition, or other disease process that would interfere with healing or the evaluation of outcome measures.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.