CHICAGO, March 21, 2013 (GLOBE NEWSWIRE) -- MAKO Surgical Corp., developer of human-interactive surgical robotic arm technology used to achieve accuracy in treating osteoarthritic disease, today announced the first results from a ten-year, prospective, randomized controlled trial evaluating the accuracy of unicompartmental knee arthroplasty (UKA) implant positioning, with and without robotic arm surgical assistance. Early results from this pivotal study are compelling, showing that robotic arm assisted UKA enhanced the accuracy of implant placement and decreased the levels of pain.
Performed under the guidance of orthopaedic surgeons Mark Blyth, M.D., Bryn Jones, M.D., Angus Maclean, M.D, and Iain Anthony, Ph.D., and Phil Rowe, Ph.D., at the Glasgow Royal Infirmary and the University of Strathclyde, in Glasgow, Scotland, the trial compared implant placement accuracy in patients receiving MAKO's RESTORIS® MCK implants using MAKO's RIO® Robotic Arm Interactive Orthopedic System to patients receiving manual placement of the Oxford® Partial Knee implant from Biomet Orthopedics. One hundred patients have been enrolled in the study and randomly assigned (50 MAKO vs. 50 Oxford) to receive UKA with or without the aid of robotic arm assistance. The three-month results from 50 patients in each group also assessed early clinical outcomes such as patient reported post-operative pain levels and satisfaction. It is anticipated the trial will ultimately have 75 patients in each group. The patients will be tracked for ten years post-operatively.
"The early results are encouraging, as the data show more accurate component placement, as well as considerably lower self-reported post-operative pain levels out to six weeks," said Dr. Blyth. "The early results suggest that robotic arm assisted UKA with the RIO system greatly enhances the accuracy of implant placement, which can be achieved with only minimal deviation from the pre-operative plan."
Poor implant positioning in UKA is associated with suboptimal functional outcome following surgery1; however, robotic arm technology for UKA provides pre-operative surgical planning for more accurate and minimal bone resection (excision of part of the bone), and intra-operative joint balancing for improved post-operative function and kinematics.
The primary endpoint of the clinical study is to validate the intra-operative implant alignment values recorded by the RIO system and to compare the accuracy of this implant positioning using robotic arm assistance with that achieved using conventional instrumentation in a randomized cohort. Among the secondary endpoints, the trial also examines early post-operative pain, and initial results show a reduction in patient reported post-op pain, which persists for almost 90 days following surgery. This ongoing trial will assess patient clinical, psychological and functional outcomes pre-operatively and at three months, one year, two years, five years and ten-years post-operatively.
"We are very happy with the early results for this randomized clinical trial, as it demonstrates the effectiveness of our RIO system and MAKOplasty® Partial Knee Resurfacing as a minimally invasive surgical option for patients with early to mid-stage osteoarthritis," said Maurice R. Ferré, M.D., president and chief executive officer of MAKO. "Results also suggest that robotic arm assisted surgery for UKA may improve recovery with regard to less pain immediately following the procedure. We believe these early results underscore the importance of accuracy and precision in UKA surgeries, and the benefits that MAKOplasty can provide surgeons and their patients."
MAKO's RIO Robotic Arm Interactive Orthopedic System coupled with its proprietary RESTORIS family of implants, enable surgeons to perform MAKOplasty for knee resurfacing and total hip arthroplasty. The RIO system overcomes limitations of conventional arthroplasty by providing auditory, visual and tactile guidance that, when integrated with the touch and feel of the surgeon's skilled hand, provide consistently reproducible precision in partial knee resurfacing and total hip replacements. This advanced treatment option is designed to relieve pain and restore range of motion for adults living with osteoarthritis and other degenerative hip diseases.
About MAKO Surgical Corp.
MAKO Surgical Corp. is a medical device company that markets its RIO Robotic-Arm Interactive Orthopedic system, with specific applications for partial knee resurfacing and total hip replacement, and proprietary RESTORIS Family of Implants for orthopedic procedures called MAKOplasty. The RIO is a surgeon-interactive tactile surgical platform that incorporates a robotic arm and patient-specific visualization technology, which enables accurate, consistently reproducible bone resection for accurate insertion and alignment of RESTORIS knee and hip implants. The MAKOplasty solution incorporates technologies enabled by an intellectual property portfolio including more than 300 U.S. and foreign, owned and licensed, patents and patent applications. Additional information can be found at www.makosurgical.com.
This press release contains forward-looking statements regarding, among other things, statements related to expectations, goals, plans, objectives and future events. MAKO intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond MAKO's ability to control or predict. Such factors, among others, may have a material adverse effect on MAKO's business, financial condition and results of operations and may include the potentially significant impact of a continued economic downturn or delayed economic recovery on the ability of MAKO's customers to secure adequate funding, including access to credit, for the purchase of MAKO's products or cause MAKO's customers to delay a purchasing decision, changes in general economic conditions and credit conditions, changes in the availability of capital and financing sources for our company and our customers, unanticipated changes in the timing of the sales cycle for MAKO's products or the vetting process undertaken by prospective customers, changes in competitive conditions and prices in MAKO's markets, changes in the relationship between supply of and demand for our products, fluctuations in costs and availability of raw materials and labor, changes in other significant operating expenses, slowdowns, delays, or inefficiencies in MAKO's product research and development cycles, unanticipated issues relating to intended product launches, decreases in sales of MAKO's principal product lines, decreases in utilization of MAKO's principal product lines or in procedure volume, increases in expenditures related to increased or changing governmental regulation or taxation of MAKO's business, both nationally and internationally, unanticipated issues in complying with domestic or foreign regulatory requirements related to MAKO's current products, including initiating and communicating product actions or product recalls and meeting Medical Device Reporting requirements and other required reporting to the United States Food and Drug Administration, or securing regulatory clearance or approvals for new products or upgrades or changes to MAKO's current products, developments adversely affecting our potential sales activities outside the United States, increases in cost containment efforts by group purchasing organizations, the impact of the United States healthcare reform legislation enacted in March 2010 on hospital spending, reimbursement, unanticipated changes in reimbursement to our customers for our products, and the taxing of medical device companies, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against MAKO, loss of key management and other personnel or inability to attract such management and other personnel, increases in costs of retaining a direct sales force and building a distributor network, unanticipated issues related to, or unanticipated changes in or difficulties associated with, the recruitment of agents and distributors of our products, and unanticipated intellectual property expenditures required to develop, market, and defend MAKO's products. These and other risks are described in greater detail under Item 1A, "Risk Factors," in MAKO's periodic filings with the Securities and Exchange Commission, including MAKO's annual report on Form 10-K for the year ended December 31, 2012 filed on February 28, 2013. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. MAKO does not undertake any obligation to release any revisions to these forward-looking statements publicly to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
"MAKOplasty®," "RESTORIS®," "RIO®," as well as the "MAKO" logo, whether standing alone or in connection with the words "MAKO Surgical Corp." are trademarks of MAKO Surgical Corp.
Oxford® is a registered trademark of Biomet Orthopedics
1 Collier WB, Engh CA, McAuley JP, et al. Factors associated with the loss of thickness of polyethylene tibial bearings after knee arthroplasty. J Bone Joint Surg Am 2007;89:1306.