Project 462285

Knee osteoarthritis (OA) is a leading cause of pain and disability globally. It currently affects over 4.4 million Canadians and the number is growing rapidly. There is currently no cure for OA, and although often claimed, no treatments have been shown to lessen OA progression, leaving surgery for late stage disease the primary management strategy. The personal and economic burden of knee OA on individuals and societies is tremendous. As the number of adults being diagnosed with knee OA is growing, and most are not suitable for surgery, there is a critical need to optimize knee OA management. Knee bracing is a potential treatment that may help people with knee OA affecting the medial/inner compartment, the most commonly affected area. However, international guidance on the use of knee bracing for knee OA is conflicting due to inconclusive evidence. We aim to provide the best possible evidence by evaluating the clinical and cost-effectiveness of adding different knee brace interventions to other standard of care treatments. We will randomly assign study participants with knee OA to one of the following four groups receiving exercise and education for OA, plus: 1) an Unloader brace; 2) a Sham Unloader brace; 3) a Neoprene sleeve; or 4) No brace. We will first conduct a pilot study to assess the feasibility of performing a future larger study. For the pilot study, an initial sample of 136 patients will be randomly assigned into one of the four intervention groups and will be followed for 12 months. Knee braces will be out-fitted with custom-built wearable devices to track brace wear time and steps. We will assess changes in clinical outcomes (such as pain and function), walking biomechanics, measures of joint damage, medication use, and various costs. Our pilot study will provide the necessary information and initial steps to successfully conduct the future "definitive" study that will define the potential role of knee bracing to help with the management of knee OA.