Mar 22 2013
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."
About MAKOplasty
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.