Clinical Orthopaedics and Related Research, DePuy, Food & Drug Administration, Hip Replacement, Johnson & Johnson, knee replacement, Orthopedic, Orthopedic surgery, Patient, SIGMA Knee System, surgery, UNited States
JOHNSON & JOHNSON : DePuy Orthopaedics Receives FDA 510(K) Clearance for TRUMATCH ® Personalized Solutions for TRUMATCH® Personalized Solutions
Brings New Level of Personalization and Efficiency to Total Knee Replacement Surgery Through Customized Instrumentation
WARSAW, IN – Aug. 19, 2011 – DePuy Orthopaedics, Inc. (DePuy) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of TRUMATCH® Personalized Solutions with the company’s SIGMA® Fixed-Bearing Knee System, one of the most widely used knee systems in the world.
TRUMATCH Personalized Solutions, which the company announced is available immediately, is a surgical instrumentation and computer software system that is designed to aid in knee implant positioning and procedure efficiency. TRUMATCH Solutions helps reduce costs by decreasing OR time by an average of 35 minutes.1 Procedures require less instrumentation and eliminate up to nine surgical steps compared to total knee replacement performed without TRUMATCH Solutions.
“TRUMATCH technology helps surgeons consistently provide knee replacement patients a customized fit and enables them to do the operation in less time,” said Daniel P. Hoeffel, MD, of Summit Orthopaedic Group, St. Paul, Minnesota.* “Patients, surgeons and the health care system all benefit from advancements in technology that provide greater efficiencies and individualize treatment.”
TRUMATCH Solutions is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. Precise positioning of the knee implant is critical to its overall performance.2 Also, the use of CT scans, rather than MRIs, results in improved bone imaging, less scanning time and lower costs.3
“TRUMATCH Personalized Solutions, only available from DePuy, represents a meaningful advance for knee replacement patients,” said Andrew Ekdahl, President, DePuy Orthopaedics. “This proprietary system is a win for patients, surgeons and hospitals that has the potential to improve patient care while reducing costs — a very important combination in health care today.” The FDA clearance of TRUMATCH Solutions was based in part on mechanical and alignment accuracy testing. TRUMATCH Solutions is available in 12 other countries.
SIGMA® Knee System
The SIGMA® Knee System has been provided for nearly 1 million patients.4 In fact, one study has shown that 10 years after surgery, 99.6 percent of patients still depend on SIGMA Knees with the fixed-bearing option in their daily lives.5 In another study of people five to ten years after surgery with Fixed-Bearing SIGMA Knee implants, most reported that the surgery had resulted in excellent relief of pain, improved range of motion and better function of the knee.6 Fixed-bearing knees are the most widely used knee replacements in the United States today. The SIGMA Knee with fixed-bearing option is a leader in this type of knee system. SIGMA Fixed- Bearing Knees are based on the clinically proven P.F.C.® Knee.7 DePuy Orthopaedics knee replacements have over 30 years of clinical experience.8
Important Safety Information
The performance of knee replacements depends on age, weight, activity level, and other factors. There are potential risks and recovery takes time. People with conditions limiting rehabilitation should not have this surgery. Only an orthopaedic surgeon can determine if knee replacement is indicated based on an individual patient’s condition.
About DePuy Orthopaedics
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, and trauma and extremities as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision – Never Stop Moving® – to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit http://www.depuy.com for more information.
*Dr. Daniel P. Hoeffel is a consultant to DePuy Orthopaedics.
1 Data on file at DePuy. Operating room time includes preparation, operating room, and turnover time.
2 Werner, F. et al. “The effect of valgus/varus malalignment on load distribution in total knee replacements.” Journal of Biomechanics. 2005;38:349-355.; Cates, H. et al. “Intramedullary Versus Extramedullary Femoral Alignment Systems in Total Knee Replacement.” Clinical Orthopaedics and Related Research. 1993;286:32-39;3. Ritter, M. et al. “Postoperative Alignment of Total Knee Replacement,” Clinical Orthopaedics and Related Research. 1994; 299:153-156; Sorrells, B. et al. “The effect of varus and valgus deformity on results of cementless mobile bearing TKA.” The Knee. 2007;14:284-288.
3 D. White, K. L. Chelule, B. B. Seedhom. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Med Robotics Comput Assist Surg 2008; 4: 224–231. “Thus, in light of the limitations of MRI noted above, in addition to the high costs, CT is likely to provide the optimum surgical outcome when used to manufacture our patient-specific templates.”
4 Data on file at DePuy.
5 Dalury, et al. Midterm results with the P.F.C. SIGMA Total Knee Arthroplasty System. The Journal of Arthroplasty. Vol. 23. No. 2, 2008: 175-181.
6 Buechel Sr., F. F., Buechel Jr., F. F., Pappas M. J., D’Alessio J. Twenty-year evaluation of meniscal bearing and rotating platform knee replacements. Clinical Orthopaedics and Related Research. 2001; 388:41-50.
7 Dixon M., et al. “Modular Fixed-Bearing Total Knee Arthroplasty with Retention of the Posterior Cruciate Ligament. A Study of Patients Followed for a Minimum of Fifteen Years. Surgery. 2005; 87:598-603.
8 Buechel, Sr., F. F., F. F. Buechel, Jr., M. J. Pappas and M.S. D’Alessio. “Twenty Year Evaluation of Meniscal Bearing and Rotating Platform Knee Replacements.” Clinical Orthopaedics and Related Research. Vol. 388, July 2001: 41-50.
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