A successful unicondylar (partial) knee replacement can be defined in a multitude of ways. The patient’s expectations and other patient specific factors such as age, weight, and diagnosis have all been identified as important factors having impact on clinical outcomes. The goal for any knee procedure is the return to a higher level of function and the ability to perform activities of daily living impacting quality of life. Dr. Raj K. Sinha, M.D., PhD., orthopaedic surgeon with S.T.A.R. Orthopaedics in La Quinta, CA, is working with Corin USA, a medical device company located in Tampa, FL, as an investigator for an Investigational Device Exemption (IDE) research study.
This research evaluates the Uniglide Mobile Bearing Unicondylar Knee System, a unicompartmental knee replacement device, to collect clinical data for submission to the FDA. The Uniglide device is not currently marketed in the U.S. and the FDA will use the results of the clinical study as part of the approval process for the U.S. The fixed bearing version of the Uniglide partial knee system is currently approved by the FDA for marketing in the U.S. The clinical study compares the mobile bearing design to the fixed bearing design of the Uniglide system. Approximately 420 subjects, male and female, will be enrolled in the study at 18 different investigational research sites within the United States.
If you are between the ages of 40 and 75 with osteoarthritis of one or both knees and want to learn more about participating in this FDA-regulated study or to fund out whether you qualify, please go to www.clinicaltrials.gov (NCT 00740376) or contact: Margaret Cutler, R.N., Clinical Research Coordinator for Dr. Raj K. Sinha, M.D., PhD at: S.T.A.R. Orthopaedics, Inc. 47110 Washington Street, Suite 201 La Quinta, California 92253 (760) 625-1652 (760) 625-1652 reference: 1. Gioe TJ, Killeen KK, Heoffel DP, Bert JM, Comfort TK, Scheltema K, Mehle S. Grimm K. Analysis of unicompartmental knee arthroplasty in a community-based implant registry. Clin. Orthop. Relat. Res. 2003 Nov; (416): 111-9