Spring Loaded Technology is committed to the clinical validation of our products and technologies to ensure their efficacy, safety, and comfort.
Knee Joint Unloading
Two studies have been completed to examine the unloading effect of Levitation:
- The first study showed that Levitation reduces contact forces in the knee joint to a level that would be achieved by losing 45 lbs of body weight1
- For an average person with knee OA that weighs 200 lbs, 45 lbs of weight loss is equal to a 22.5% reduction from their starting body weight. Previous research shows that weight loss of at least 20% is required for the best clinical outcomes2.
- The second study demonstrated that Levitation can significantly reduce patellofemoral and tibiofemoral joint contact forces3.
A systematic survey of Levitation brace users with knee osteoarthritis demonstrated significant clinical benefits of Levitation related to pain, function, mobility, use of medication and other treatments and quality of life4.
Among other key findings, this study demonstrated that:
- 95% of users with knee OA experienced a reduction in pain. The improvement in pain scores exceeded the “PASS” threshold5; that is, the pain score below which patients typically consider themselves well.
- A significant improvement of 16 points was observed on the Lower Extremity Function Scale (LEFS). The minimum clinically relevant change on the LEFS is 9 points6.
- 85% of users experienced mobility improvements; 86% reported an improvement in quality of life.
- 47% of users who were regularly using pain medications before Levitation were able to reduce or eliminate their use of medications.
- 48% of users who were considering surgery before using Levitation were able to delay or eliminate the need for surgery after using Levitation.
- On average, brace users were able to increase their physical activity by 8 hours per week.
The improvement in pain scores exceeded the externally validated “PASS” threshold5; that is, the pain score below which patients typically consider themselves well.
Spring Loaded is currently collaborating with researchers at the University of Calgary to provide independent testing and validation of our knee brace products.
We are now running fully-controlled human performance studies in collaboration with third-party researchers to further validate the effectiveness of our bionic knee brace, Levitation, in individuals with knee osteoarthritis. These researchers specialize in knee joint biomechanics and knee injury and disease including osteoarthritis. Preliminary data from these studies demonstrates a positive effect of wearing the brace during activities of daily living such as sitting and standing from a chair, and going up and down stairs.
Spring Loaded actively collaborates with researchers at Dalhousie University, the University of New Brunswick, the University of Calgary, and Guelph University. These researchers have provided insight on our design process and are now conducting independent testing and validation of our knee brace products in a variety of different circumstances.
- Budarick, A.R., MacKeil, B.E., Fitzgerald, S., Cowper-Smith, C.D., 2020. Design Evaluation of a Novel Multicompartment Unloader Knee Brace. J. Biomech. Eng. 142.
- Messier, S. P., Resnik, A. E., Beavers, D. P., Mihalko, S. L., Miller, G. D., Nicklas, B. J., 418 DeVita, P., Hunter, D. J., Lyles, M. F., Eckstein, F., Guermazi, A., and Loeser, R. F., 419 2018, “Intentional Weight Loss in Overweight and Obese Patients With Knee 420 Osteoarthritis: Is More Better?,” Arthritis Care Res., 70(11), pp. 1569–1575.
- McGibbon, C.A., Brandon, S.C., Bishop, E.L., Cowper-Smith, C., Biden, E.N. 2020. Biomechanical study of a novel tri-compartmental unloader brace for the knee. In Preparation.
- Budarick, A.R., Bishop, E. and Cowper-Smith, C., 2020. Evaluation of a new orthotic for multi-compartment knee osteoarthritis: a retrospective pilot survey. In Preparation.
- Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: The patient acceptable symptom state. Ann Rheum Dis. 2005;64(1):34–7
- Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): Scale Development, Measurement Properties, and Clinical Application. Phys Ther. 1999;79(4):371–83.