A Treatment Study for Single Articular Cartilage Lesion of the Knee--NOVOCART®3D (N3D)
Official Title: A 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
The purpose of this research study is to evaluate an investigational procedure for treatment of knee cartilage defects. If eligible, you will receive one of two possible surgical procedures. One is the investigational procedure under study, utilizes the Novocart® 3D autologous cartilage implant system. The other possible procedure is called Microfracture and is one of the current standard of care options to treat your condition. Both surgical procedures will be followed by pain and knee function assessments and a course of physical rehabilitation.
•Little response to conservative treatment (non-operative treatments such as physical therapy, weight loss)
•Single articular cartilage lesion on the femoral condyle (round projection at the end of the femur) 2-6 cm2
•BMI less than 40
•Instability of the knee joint
•Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
•Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.