Randomized Pivotal study to evaluate the safety of the Cartilage Autograft Implantation System (CAIS) for the surgical treatment of articular cartilage lesions of the knee.
Principal Investigator: Brian J. Cole, M.D., M.B.A.
Sponsored By: Advanced Technologies and Regenerative Therapeutics, LLC
Clinical Trial Protocol Description
The purpose of this study is to determine the safety and efficacy of CAIS compared to microfracture at 12 months post-treatment, with the primary efficacy assessment based on an analysis of non-inferiority of CAIS to microfracture for reduction in knee pain.
A total of approximately 300 subjects will be enrolled in this study at approximately 40 research sites in North America and Europe. Approximately 10 to 15 subjects are expected to participate at Rush in the study. Subjects will be enrolled and treated divided into the following 2 parts:
Approximately 250 subjects (or approximately 119 subjects per group) will be treated in the randomized part of the study. Intraoperative assignment will be based on lesion size post-debridement.
Approximately 50 additional subjects will be concurrently enrolled in the non-randomized part of the study and will receive CAIS. Subjects enrolled in the non-randomized part must meet the same eligibility criteria except those pertaining to lesion size.
Clinical Trial Eligibility Criteria
In order to participate you must be:
- Between the ages of 18 and 65 years of age
- A candidate for cartilage repair on the femoral articular surfaces
- Physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
- Able and willing to follow a standardized rehabilitation protocol
You will be excluded from the study if you:
- Require bilateral knee surgery
- Are receiving workers' compensation or are currently involved in litigation relating to the index knee
- Have received intra-articular steroid therapy or intra-articular hyaluronic acid therapy for the index knee within the past six months
- Have undergone prior ACL/PCL reconstruction surgery within the past 12 months or have had a prior total or subtotal meniscectomy
This is a partial list of inclusion and exclusion criteria. For more information, contact Michelle Karlin at 312.432.2381.
FDA Office of Regulatory Affairs # 08071602