Healthcare Industry News:  joint replacement 

Devices Orthopaedic

 News Release - February 27, 2008

OtisMed Launches OtisKnee(TM) Patient Registry

HAYWARD, Calif.--(HSMN NewsFeed)--Orthopedic technology company OtisMed Corporation has announced the launch of a patient registry designed to gather clinical and economic outcomes data on OtisKnee, a new total knee replacement technology that for the first time allows surgeons to customize the size and placement of the knee implant to each individual patient’s anatomy.

Called COMFORT (Comprehensive Outcomes Measures for OtisKnee Replacement Technique), the registry is expected to include thousands of patients at hundreds of hospitals across the United States. Data gathered in the COMFORT registry will be used to evaluate a variety of measures, including post-operative pain, range of motion, patient satisfaction and recovery rate as well as surgical time, operating room set-up time and cost, and hospital length of stay. All consented patient data will be gathered using the Knee Society Scoring System, the Oxford Knee Score and the widely utilized SF-12 scoring method.

Since its limited U.S. launch in June of 2007, the OtisKnee technique has been performed by more than 400 surgeons on more than 5,000 patients. The new “custom-fit” OtisKnee approach enables surgeons to preserve more bone and ligaments, allowing for better implant fit and alignment. OtisKnee surgeons and patients have reported quicker recovery times, less pain and greater return to function than with traditional and computer-assisted total knee replacement techniques. OtisKnee surgeons have also reported reduced surgical times, simplified surgical set-up as well as quicker patient discharge.

Currently optimized for use with knee implants from Stryker Corp. and Biomet Inc., the custom-fit total knee replacement with OtisKnee is achieved in a few steps, before and during surgery. Prior to surgery, an MRI is performed to take very precise measurements of the patient’s arthritic knee. Second, proprietary computer software creates a 3-D image of that knee, and then virtually corrects the deformity to return the knee to its pre-arthritic state. Third, a computerized 3-D image of the implant to be used in the patient’s surgery is then ShapeMatched™ to the anatomically correct virtual knee model. This helps determine the correct implant size and placement, based on the patient’s own normal (non-arthritic) knee anatomy. Last, using all of this information, special cutting guides are created for the surgeon to use during the procedure. These patient-specific cutting guides, which are accurate to within a few millimeters, indicate to the surgeon exactly where to make bone cuts so that the knee replacement is customized for the individual patient.

“While total knee replacement is a very well established and common procedure, the published literature has shown that approximately 14 percent of knee replacement patients are unsatisfied with their results. New, more patient-specific technologies like OtisKnee may help us narrow that gap,” said Herrick Siegel, M.D., a board-certified orthopedic surgeon and associate professor of surgery at the University of Alabama at Birmingham. “The COMFORT registry will be very important for objectively evaluating the custom-fit OtisKnee approach against traditional and computer-assisted techniques, ultimately helping surgeons and patients make the best choice for them.”

Data from the COMFORT registry will be reviewed and evaluated by an independent clinical oversight team comprised of five experienced orthopedic surgeons across the United States. OtisMed expects initial data from the COMFORT registry to be submitted for publication within the second quarter of 2008.

About OtisMed Corporation

OtisMed Corporation is a privately held orthopedic technology company dedicated to providing new solutions for complex clinical problems in joint replacement. OtisMed’s focus is on developing and commercializing highly accurate and cost effective surgical solutions that are customized to each patient. OtisMed’s initial offering is the OtisKnee™, a groundbreaking new product that enables surgeons to offer custom fit total knee replacement. With OtisKnee, surgeons can for the very first time match the size and placement of the implant to the patient’s unique and normal (non-diseased) knee anatomy.

Founded in 2005, the company has received funding from Kleiner Perkins Caufield & Byers. For more information, call 888-OTISMED or visit www.otismed.com.

OtisKnee™ and ShapeMatch™ are registered trademarks of OtisMed Corp. U.S. and foreign patent applications are pending.


Source: OtisMed

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