Moximed, Inc. announced today that the KineSpring® System, an implantable medical spring for knee osteoarthritis that works by unloading the weight on the diseased joint, has been successfully implanted in the first patients enrolled in the UK arm of its multi-centre GOAL study. This non-randomized pivotal trial is comparing the safety and effectiveness of the KineSpring System with high tibial osteotomy (HTO), a procedure used to treat the pain and discomfort associated with medial compartment knee osteoarthritis, in a minimum of 225 patients across Europe. The UK principal investigator for the study is Mr. Michael McNicholas, Consultant Trauma and Orthopaedic surgeon, Aintree University Hospital, Liverpool.
"The KineSpring System is emerging as an effective treatment option in patients with early to moderate knee osteoarthritis. These patients are typically still very active and would like to remain so. This creates a significant need for a procedure that potentially delays or avoids knee replacement," noted Mr. McNicholas. "With this in mind, the GOAL study has been designed to enable us to see how the KineSpring System compares directly to HTO, a common, but more invasive, procedure offered to medial knee osteoarthritis patients."
The purpose of the post-market study is to demonstrate that the KineSpring System is non-inferior to HTO in the treatment of symptoms associated with osteoarthritis of the medial compartment of the knee. Participating centres in the UK include Royal Bournemouth Hospital and North Hampshire Hospital, Basingstoke, with several more to be added.
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