The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trialJames K. Sullivan, James J. Irrgang, Elena Losina, Clare Safran-Norton, Jamie Collins, Swastina Shrestha, Faith Selzer, Kim Bennell, Leslie Bisson, Angela T. Chen, Courtney K. Dawson, Alexandra B. Gil, Morgan H. Jones, Melissa A. Kluczynski, Kathleen Lafferty, Jeffrey Lange, Emma C. Lape, John Leddy, Aaron V. Mares, Kurt Spindler, Jennifer Turczyk and Jeffrey N. Katz
Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects.
The Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs.
The goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges.
The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004. on February 14, 2017.