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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.v19.i3.60
pages 209-214

Endpoint Assessment in Orthopedic Implant Trials: Current Systems and Approaches

Jihee Han
Division of Orthopaedic Surgery, Department of Surgery and Department of Clinical Epidemiology & Biostatistics. McMaster University, Ontario L8L 2X2, Canada
Natalie Kuurstra
Division of Orthopaedic Surgery, Department of Surgery and Department of Clinical Epidemiology & Biostatistics. McMaster University, Ontario L8L 2X2, Canada
Christopher Vannabouathong
Division of Orthopaedic Surgery, Department of Surgery and Department of Clinical Epidemiology & Biostatistics. McMaster University, Ontario L8L 2X2, Canada; Global Research Solutions, Inc., Burlington, Ontario, Canada

ABSTRACT

Quality orthopedic trauma research is imperative as it provides clinical guidance in practicing evidence-based medicine. However, meaningful orthopedic trauma research, including orthopedic implant trials, is often difficult as there are very few accepted standard definitions in outcomes assessment. The unique challenges faced by investigators, especially in conducting large multi-site, multi-national randomized implant trials, can be addressed by having the adequate infrastructure in place, which includes having a central Adjudication Committee to conduct an objective outcomes assessment. While the nature of the adjudication process is complex and labor-intensive, a web-based system, such as the Global AdjudicatorTM, can greatly facilitate the adjudication process. The purpose of this manuscript is to provide an overview on the nature of orthopedic implant trials, with an emphasis on conducting reliable outcomes assessment.