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limiting your activities? Knee Pain Research Study Opportunity Purpose of the Research Study: We are conducting a research study evaluating an investigational surgical treatment intended to repair knee cartilage damage and ease knee pain. Eligible participants must be between the ages of 18 and 55 & have knee pain caused by knee cartilage damage. The presence of knee cartilage damage is assessed by the study physician at the first visit and involves a set of diagnostic x-rays and an MRI. Qualified participants will receive medical care, including an MRI & knee surgery. This study will evaluate the safety and effectiveness of the Cartilage Autograft Implantation System or CAIS™, which is a surgical treatment for cartilage damage in the knee. CAIS will be compared to a standard surgical treatment called microfracture. List of diagnostic procedures involved: Radiographs (x-rays) of the knee will be done two (2) times over the course of 48 months An MRI of the knee will be done seven (7) times over the course of 48 months. List of surgical procedures involved (if eligible): Diagnostic arthroscopy There is a 50 % chance of receiving either microfracture (standard surgical treatment) or CAIS (study surgical treatment) Length of time of commitment to the study: Your participation is expected to last a minimum of 48 months, which will include 1 visit prior to the surgery, 1 visit for surgery, and at least 11 visits to the physician’s office/clinic to follow-up on your progress. Investigational Drug or Device: Cartilage Autograft Implantation System (CAIS) Compensation: Participants will be compensated for their time and travel. Contact: For more information about enrolling in this study, please visit the study website at www.kneepainstudy.com or contact Cara Fontaine or 212-598-6521. |
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