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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.2013010140
pages 161-173

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

Jack Farr
OrthoIndy Knee Care Institute, Indiana Orthopaedic Hospital; Voluntary Professorship in Orthopaedic Surgery, Indiana School of Medicine, Indianapolis, Indiana
Dennis C. Crawford
Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, Oregon
David R. Diduch
Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia
Elizabeth A. Arendt
Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota
C. Benjamin Ma
Department of Orthopaedic Surgery, School of Medicine, University of California, San Francisco, California
Chuan Silvia Li
Global Research Solutions, Inc., Burlington, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

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.