Opportunities - Evaluating a New Knee Brace Design for Knee Osteoarthritis
Evaluating a New Knee Brace Design for Knee Osteoarthritis
University of Calgary
Osteoarthritis (OA) is a disabling joint disease that affects about 1 in every 3 Canadians over the age of 25. OA affects joints and results in loss of cartilage which can be a major source of pain, disability, and decreased quality of life. Total knee replacement surgery can be used to restore mobility, however, the risk for expensive and invasive revision surgery is higher in OA patients younger than 65, so finding alternative, early treatment interventions is important for societal and economic health.
Existing knee OA braces are designed to unload part of the joint (ie. decrease the forces going through the joint) to help reduce symptoms of pain and allow patients to participate in physical activity. However, because the majority of knee OA braces unload only one side of the knee, they are not designed for most patients who suffer from patellofemoral (kneecap) or multi-compartment knee OA.
The Levitation “Tri-Compartment Unloader” (TCU) knee brace was developed by Spring Loaded Technology . This brace was designed to reduce knee OA pain by reducing compressive forces in all three compartments of the knee with a silicone “liquid spring” providing knee extension assistance. Survey evidence suggests the TCU brace provides pain relief and improved function to long-term wearers with knee OA, especially those with involvement of the patellofemoral compartment. However, a controlled clinical study involving patients with patellofemoral or multi-compartment knee OA needs to be performed to fully understand the benefits of the TCU brace to a larger group.
The Levitation TCU knee brace represents a promising new technology for reducing pain and maintaining mobility in patients who have or are developing knee OA. Generating scientific evidence on the effectiveness of the TCU brace will allow patients and healthcare providers to make informed decisions regarding their treatment options for knee OA. Involving patients, as partners, in the study design, conduct, interpretation and dissemination activities will increase the relevance and utility of results and the overall impact of this study.
Roles and Responsibilities
We are looking for 4 patient partners with experience of OA, either their own or as family members or caregivers, to form the Patient Advisory Committee (PAC).
Patient partners will provide critical input to help reduce barriers to participation for study participants and help to revise recruitment materials from a patient perspective. Patient feedback on study design in the early stages will ensure the research is focused on public’s interest and concerns and the unique perspective toward interpretation of results will highlight findings that are more actionable and relevant to the public.
The 2 focus groups held during the 1-year study will be as follows:
1st Focus Group: will be used to review and collect feedback on the proposed clinical trial research objectives, design, methods and outcome. Patient partners will also be asked to test out the study protocol and provide feedback.
2nd Focus Group: will be used to review the results of the pilot study and ask for ideas on ways to share the knowledge generated including informing language and presentation.
In-person participation is preferred, however, participation by teleconference or video conferencing is an option for those who cannot attend in person.
The expected timeframe of this project is 1 year beginning May 2020.
We anticipate 2 full-day focus groups and 1 half-day interim meeting with patient partners, as well as 2-4 additional interactions with patient partners throughout the study for training, protocol testing and completing evaluations.
Patient partners will be provided with the appropriate tools and training needed to meaningfully engage in the research project.
Reimbursement will be provided for all travel and other expenses associated with participating in the events.
Patient partners will be provided with an honorarium for their valued experience, expertise and participation in focus groups and meetings.
Project Team Contact Information
Emily Bishop Janet Ronsky