New Clinical Results Further Distance the BIRMINGHAM HIPT Resurfacing System From Failed Metal-on-Metal Hip Implants
Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announced the results of a new study for its BIRMINGHAM HIPT Resurfacing (BHR) System. The study, carried out at the request of the FDA, followed the progress of the first 400 BHR patients in the United Kingdom and found that after 10 years, 99% were either satisfied or extremely satisfied with their BHR procedure.
"These results further exemplify why the BHR Hip is unlike any other metal-on-metal implant," says John Soto, Senior Vice President for Smith & Nephew's Global Hip Franchise. "Not only does the BHR Hip offer all the advantages of hip resurfacing, including bone-conservation, greater range of motion and decreased risk of dislocation, but it does so while maintaining implant survivorship rates that are on par with, or in some patient populations even better than, traditional total hip replacement which has long been considered the most successful orthopaedic surgical procedure for relieving chronic pain." In addition to patient satisfaction, the 10-year BHR data showed: -- The Oswestry Modified Harris Hip Score (OMHHS) averaged 92.5 points - demonstrating excellent long-term clinical implant function.i -- The implant survival rate according to the Kaplan-Meier analysis was 95.9% - well exceeding the 10-year survivorship threshold of 90% for implants as established by the National Institute for Health and Clinical Science (NICE)ii -- A radiographic success rate of 99.7% was observed by independent radiographic review.
Recently, several metal-on-metal hip implants have been taken off the market by other device companies due to higher than expected failure rates and increasing patient safety concerns. The latest results show that the BHR Hip stands apart from these and many other metal-on-metal resurfacing devices. Key features of the BHR Hip that contribute to this success include its distinctive metallurgy and its sophisticated design geometry.
The BHR Hip has a distinctive metallurgy heritage which goes back more than 30 years and includes first-generation metal-on-metal materials.
In particular, the BHR Hip is produced using the "As Cast" process which maintains the quantity and quality of carbides in the metal and thereby creates a metal with high wear resistance. Additionally, the BHR Hip's design geometry replicates the natural hip's ability to pull the body's own joint fluids into the space between the ball and socket.
Much like the lubricating barrier in a healthy hip, BHR's geometry creates a natural fluid layer between the femoral head and the cup that the two metal surfaces glide across during physical activity.
Without this lubrication, higher metal wear occurs and the likelihood of premature failure increases.
"The fact is that the BHR Hip is not like other metal-on-metal hip implants," adds Soto. "It really is in a class all its own - it's safe and effective, and is the best choice for the right patient." The 10-year study sample, carried out at the request of the FDA, was comprised of patients implanted by the primary investigator and BHR design surgeon Derek McMinn, MD FRCS of The McMinn Centre in Birmingham, England. The study included 258 males and 142 females who were implanted either unilaterally or bilaterally and had an average age of 53.2 years (range: 23-84 years).
About the Birmingham Hip Resurfacing implant While the BHR implant closely matches the size of a patient's natural femoral head (hip ball), it is substantially larger than the femoral head of a traditional total hip replacement implant. This increased size translates to greater stability in the new joint, and it decreases the chance of dislocation of the implant after surgery.
Dislocation is a leading cause of implant failure after total hip replacement.
Total hip replacement involves the removal of the entire femoral head and neck. The BHR technique, however, leaves the head and neck untouched. It is this neck length and angle that determines the natural length of a patient's leg after surgery, and since it is not removed and replaced with an artificial device during the resurfacing procedure, there is a greater likelihood of maintaining accurate leg length.
To read more clinical test results of the Birmingham Hip, click here.
About Smith & Nephew Smith & Nephew is a global medical technology business dedicated to helping improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine, Trauma and Clinical Therapies, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
Forward-Looking Statements This press release contains certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In particular, statements regarding planned growth in our business and in our operating margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline.
These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements.
Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.
All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.
i Harris Hip Score is a tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question (pain, function, functional activity and physical exam) is awarded a certain number of points based on how it is answered. The score is reported as 90-100 for excellent results, 80-89 for good results, 70-79 for fair results, 60-69 for poor. Any score below 60 is considered a failed result ii National Institute for Clinical Excellence (NICE): Guidance for the Selection of Prostheses for Total Hip Replacement, 2000 SOURCE Smith & Nephew -0- 02/09/2012 /CONTACT: CONTACT: Analyst/Investor Inquiries: Phil Cowdy, Smith & Nephew, +44(0)20-7401-7646; Media Inquiries: Brad Merrick, Smith & Nephew, +1-901-399-1089, email@example.com /Web Site: http://www.smith-nephew.com (NYSE:SNN / LSE:SN) / CO: Smith & Nephew ST: Tennessee England IN: MTC HEA SU: TRI PRN -- CL51039 -- 0000 02/09/2012 20:00:00 EDT http://www.prnewswire.c