title: Prospective, multi-center, pilot study to evaluate symptom relief in patients with medial knee osteoarthritis (OA) treated with the KineSpring® knee implant for load reduction - the SOAR protocol.
abstract: The study described here is designed as a prospective, multicenter, open-label, single-arm pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the KineSpring® Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20% compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.
authors.affiliation: OrthoIndy Knee Care Institute, Indiana Orthopaedic Hospital; Voluntary Professorship in Orthopaedic Surgery, Indiana School of Medicine, Indianapolis, Indiana.
authors.forename: Jack
authors.initials: J
authors.lastname: Farr
authors.affiliation: Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, Oregon.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Crawford
authors.affiliation: Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia.
authors.forename: David R
authors.initials: DR
authors.lastname: Diduch
authors.affiliation: Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Arendt
authors.affiliation: Department of Orthopaedic Surgery, School of Medicine, University of California, San Francisco, California.
authors.forename: C Benjamin
authors.initials: CB
authors.lastname: Ma
authors.affiliation: Global Research Solutions, Inc., Burlington, Ontario, Canada.
authors.forename: Chuan Silvia
authors.initials: CS
authors.lastname: Li
mesh_terms: D006801:Humans; D007719:Knee Joint / Q000601:surgery*; D007720:Knee Prosthesis; D020370:Osteoarthritis, Knee / Q000601:surgery*; D063868:Patient Outcome Assessment; D010865:Pilot Projects; D011446:Prospective Studies; D012107:Research Design