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Pivotal Study to Focus on System to Repair Knee Cartilage Damage

Can the Cartilage Autograft Implantation System (CAIS) improve pain and function for patients undergoing surgical treatment for knee cartilage damage? Craig Levitz, MD, South Nassau's chairman of Orthopedics and director of South Nassau's Center for Advanced Orthopedics, is among a group of orthopedic surgeons in the United States that is enrolling candidates for a multi-center, randomized, pivotal clinical trial that will evaluate the safety and efficacy of CAIS for the surgical treatment of articular cartilage tears (lesions) of the knee. This pivotal clinical trial will include approximately 300 patients to assess if the device is safe and effective.

Presently, Autologous Chondrocyte Implantation (using one's own cartilage to treat cartilage damage, and known as ACI) and marrow stimulation (such as microfracture) are the primary surgical treatments used to repair cartilage defects. The ACI technique involves harvesting cartilage from the patient's knee, growing the cartilage outside the body (called culture expansion), and then implanting the cartilage during a second surgical procedure. To perform marrow stimulation techniques, the surgeon uses a pick-like tool to make small holes in the bone near the cartilage damage to prompt the body to make new cartilage.

Dr. Levitz and the researchers want to find out if using CAIS is as effective and beneficial as the microfracture approach. CAIS uses the patient's own cartilage, fastens it to a synthetic implant and implants it in the patient's knee during a single surgical treatment. Patients who qualify for the study, which is sponsored by an affiliate of Johnson & Johnson (Advanced Technologies and Regenerative Medicine, LLC), will receive either the microfracture treatment or the CATS treatment. No patient will receive placebo treatment.

Neither the patient nor the doctor can choose which treatment the patient will receive. The patient will be randomly assigned to one of the two treatment plans.

Following the operation, the patient will visit with Dr. Levitz at least twice during the first few weeks after surgery, then about every three months for the first year, and then every 6 months for the next three years. The patient will have an MRI four times in the first year, and then one every year during the study.

If the patient is in the experimental group, CAIS will be provided without cost; however, the patient's health plan will need to pay for the costs of items that are covered by healthcare plans. The control treatment cost for this study is considered part of standard of care and will be billed to the patient's insurance carrier. As with all treatments, expenses not covered by this study may be billed to the patient.

If you are interested in participating, or have questions about the clinical trial, call Dr. Levitz at (516) 536-2800.

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