Poor implant positioning in UKA is associated with suboptimal functional outcome following surgery 1; 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 MAKOplastyMAKO'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.