SOURCE: PLUS Orthopedics USA, Inc.

February 16, 2007 08:00 ET

Knee Replacement Surgery Results Are Improved With the Plus Orthopedics PiGalileo™ Computer-Assisted Surgery System, Reports The Journal of Bone and Joint Surgery

Plus Orthopedics' PiGalileo™ System Improves Knee Alignment

SAN DIEGO, CA -- (MARKET WIRE) -- February 16, 2007 -- 2007 AAOS ANNUAL MEETING BOOTH #1642 -- According to the results of a prospective, randomized study published in the February, 2007 edition of The Journal of Bone and Joint Surgery (JBJS), the PLUS Orthopedics PiGalileo™ computer-assisted surgery system significantly improves knee implant alignment during total knee replacement surgery, as compared to conventional total knee replacement.

Medical literature has shown that one of the most common causes of joint implant failure is implant misalignment. In fact, a misalignment of only 3-degrees is strongly correlated to excessive wear and tear on the joint and implant failure over time, requiring re-operation. In this study the authors reported that 25% of the conventional procedures fell outside of this accepted tolerance range (3-degrees), as compared to only approximately 3% with the PiGalileo™ system. In short, the results of the study show that when the PiGalileo™ system is utilized the prosthesis is implanted more precisely, with significantly improved overall alignment (p = 0.004) as compared to the conventional method(1).

"The results of this study further validate the clinical benefits of PiGalileo™, where it is logical that a well-aligned and balanced knee will have less wear and last longer, just as well-aligned and balanced automobile tires wear less and last longer," said Craig Grabell, CEO of Plus Orthopedics, USA. "It is gratifying to offer patients and surgeons such a cutting-edge technology that, according to this study, significantly reduces the 25% misalignment rate seen with the conventional procedure(1), which we believe will ultimately raise the standard of healthcare for all patients undergoing knee replacement surgery."

Conducted by Dr. Georg Matziolis and colleagues at the Center for Musculoskeletal Surgery, Charité-University Medicine in Berlin, Germany, the study included 60 patients with arthritis of the knee who were undergoing total knee arthroplasty. The patients were randomly assigned to one of two treatment groups: the group to undergo surgery with use of the PiGalileo™ system (32 knees), and the group to undergo the conventional procedure (28 knees). The post-operative spatial position and alignment of the knee implants was evaluated three-dimensionally with the use of computerized tomography (CT), which eliminated projection-related imaging errors.

The PiGalileo™ Computer-Assisted Orthopedic Surgery System from PLUS Orthopedics combines advanced Computer-Assisted Surgery and robotic instrument positioning technologies to assist the surgeon in total knee replacement procedures. Surgeries done with PiGalileo™ are still performed by a surgeon, with cut guides that can be precisely adjusted with 6-degrees of freedom. By rigidly holding the femoral cut guide, the system eliminates the need for pins which are a significant source of alignment deviation. Moreover, the technology provides valuable intra-operative feedback to the surgeon to help improve precision and ligament balance, thereby potentially leading to better balance, implant alignment, and positioning. The PiGalileo™ System has been used for more than 15,000 joint replacement procedures internationally since 1999.

The PiGalileo™ Computer-Assisted Orthopedic Surgery System can be seen at the 2007 AAOS Annual Meeting (February 14-16) at booth #1642.

About PLUS Orthopedics USA, Inc.

PLUS Orthopedics USA, Inc. is a wholly owned subsidiary of PLUS Orthopedics Holding, AG, a manufacturer of implant systems for the hip, knee and shoulder joints, as well as products for the treatment of orthopedic trauma, since 1997. PLUS Orthopedics USA, Inc., headquartered in San Diego, California, is now bringing these products to patients across the U.S. with a commitment to offering our customers high quality products and services with proven results. For more information visit the company's web site at www.plusortho.com.

(1) Although the results of this study demonstrate significantly improved overall alignment and femoral alignment, there was no significant difference in tibial alignment and tibial rotation, where there was a considerable range of tibial rotation for both groups. Moreover, there was also no significant difference in femoral rotation.

MC00277v01

Contact Information