Neocartilage Implant to Treat Cartilage Lesions of the Knee

• Knee Injury and Osteoarthritis Outcomes Scores (KOOS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
  
  

• IKDC Knee Examination [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ] [ Designated as safety issue: No ]
  
• Subject reported questionnaires [ Time Frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years ] [ Designated as safety issue: No ]
  Various questionnaires are required to be completed by the subject before and after treatment throughout the study.
  
  

In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.