Favorable Results of Level-1 Clinical Study on Wright’s GRAFTJACKET® Matrix for Augmenting Rotator Cuff Repair Presented at Recent Arthroscopy Association of North America Meeting
ARLINGTON, Tenn.–(BUSINESS WIRE)–Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, announced today that results of a prospective, randomized controlled clinical study evaluating biologic augmentation of challenging arthroscopic rotator cuff repairs with GRAFTJACKET® Matrix were presented by F. Alan Barber, MD at the recent Arthroscopy Association of North America (AANA) annual meeting. The study showed rotator cuff repairs augmented with Wright’s GRAFTJACKET® Matrix were intact in 84% of the patients while only 46% of those in the control group were intact as measured by magnetic resonance imaging (MRI). In addition, the study showed that patients in the GRAFTJACKET® Matrix study group gained statistically superior function compared to the control group. Joseph P. Burns, MD of the Southern California Orthopedic Institute, Allen Deutsch, MD of the Kelsey-Seybold Clinic of Orthopaedics, and Marc R Labbe MD of the Bone & Joint Clinic of South Houston were also authors on the paper presented.
Dr. Barber of the Plano Orthopedic & Sports Medicine Center in Plano, TX, commented, “This multi-center clinical study supported the hypothesis that augmentation with GRAFTJACKET® Matrix resulted in improved repair healing for large rotator cuff tears and provided statistically better functional outcome scores.” The arthroscopic arm of the Level-1 rotator cuff study, presented at AANA, included 36 patients with arthroscopic rotator cuff repair including 20 patients in the GRAFTJACKET® Matrix study group and 16 in the control group. All tears were classified as “large to massive,” which is defined as measuring 3 to 5 cm in width with at least two-tendon involvement; the mean time to follow-up was 18 months (range 12 to 33). MRI follow-up at a minimum of 12 months showed 84% of the repairs with GRAFTJACKET® Matrix were intact, while only 46% of those in the control group were intact (p<0.05). In addition, there was significant improvement in the American Shoulder & Elbow Surgeons (ASES) and Constant-Murley scores (p=0.02 and 0.03 respectively).
The treatment of large to massive rotator cuff tears remains a significant clinical challenge with re-tear rates reported as high as 90%1. There are over 400,000 rotator cuff repairs performed annually in the United States with an estimated 75,000 of these considered large to massive. GRAFTJACKET® Matrix is the only soft-tissue graft shown to reduce the re-tear rate and provide functional improvements post-operatively in a multi-center, prospective, randomized, controlled study. These benefits may ultimately lead to better clinical outcomes for patients as well as economic benefits for the health care system by reducing the need for costly revision surgeries.
Wright Medical’s GRAFTJACKET® Matrix is a processed three-dimensional human dermal tissue matrix that allows the body to rebuild areas of deficient tissue. After GRAFTJACKET® Matrix is applied to soft-tissue repair, the body’s natural repair process revascularizes and repopulates the GRAFTJACKET® Matrix with its own cells, gradually converting the graft into the patient’s own living tissue. Wright is the exclusive distributor of this acellular human dermis technology, provided through a supply and development relationship with LifeCell Corporation, a KCI company, for orthopaedic and podiatric applications, including diabetic foot wounds, in the United States, Canada and other select international markets.
Wright Medical Group, Inc. is a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market. The Company specializes in the design, manufacture and marketing of devices and biologic products for extremity, hip and knee repair and reconstruction. The Company has been in business for 60 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit the Company’s website at www.wmt.com.
This press release contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements.Such risks and uncertainties include those discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009, under the heading, “Risk Factors”). Readers should not place undue reliance on forward-looking statements.Such statements are made as of the date of this press release, and we undertake no obligation to update such statements after this date.
1. Galatz LM, Ball CM, Teefey SA, et al: The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am 86:219-224, 2004
