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Cartilage Study

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Drs. Randall Holcomb and Kenneth Weiss will be the first surgeons to enroll patients in Memphis in an investigational study of a single-stage cartilage repair procedure for the knee. The study will be a randomized, prospective multi-center clinical trial evaluating the safety and effectiveness of the Cartilage Autograft Implantation System (CAISTM), as a surgical procedure of cartilage lesion(s) in the knee compared to a standard surgical treatment called microfracture.

“Most clinicians involved in cartilage regeneration research agree that the future lies in techniques that utilize cartilage cells on a bio-scaffold. This investigational study utilizes this type of advanced technology and we are hopeful that this technology will prove to be a valuable tool for our patients who have knee pain related to cartilage problems,” said Randy Holcomb, MD, a clinical investigator and sports medicine orthopedic surgeon at OrthoMemphis.

“This is a well designed clinical trial that will generate important evidence-based data on a potential alternative to the current standard procedure in the exciting new field of cartilage  repair,” said Brian Cole, MD, clinical investigator and director of the Rush Cartilage Restoration Center in Chicago, one of the testing sites.

  “This investigational study will evaluate whether the CAIS technology has the potential to provide greater benefit than microfracture for the repair of cartilage defects of the knee.”said Kenneth Weiss, MD, a clinical investigator and sports medicine orthopaedic surgeon at OrthoMemphis. Patients between 18 and 55 years of age, who have normal symptoms of focal knee pain, such as swelling, fluid in the knee, catching, limited motion or stiffness, may be considered for the screening phase of the study. The CAIS procedure is limited to patients with a small articular cartilage defect of the knee on the femoral surfaces (end of the thigh bone); and meet all other inclusion and exclusion criteria of the study.

 During the CAIS procedure, surgeons remove a sample of healthy cartilage from a non-weight or low-weight bearing area of the patient’s knee. The tissue is broken up and combined with a unique absorbable material that provides a scaffold for cell growth. This scaffold is then implanted at the site of cartilage damage. The CAIS procedure can be applied in one surgical procedure.

 This multi-center clinical trial will compare CAIS to microfracture surgery to determine which procedure will better reduce pain and improve function levels of patients with damaged knee cartilage.  The trial will enroll up to 364 patients at up to 40 investigative sites throughout North America, and follow their progress for four years.

 Industry estimates indicate there are more than 400,000 surgical cartilage repair procedures performed each year.  The number of procedures is expected to rise with an increasingly active aging population.

For more information on this trial, please call (901) 259-1600 extension 1508

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