Why do we need a Biomechanics Lab? Quite simply, we believe in qualifying our product claims before we make them. No other bracing company has a dedicated lab that routinely publishes medical studies.
Biomechanical testing allows us to test the efficacy of our products, and was instrumental in the development of our patented Four Points of Leverage bracing methodology. DJO does both in-house surrogate testing, along with external clinical research. By utilizing a surrogate, or a replacement limb for testing, we get an idea of how a brace might function on a leg. Our unique mechanical surrogate enables us to test products again and again, obtaining repeatable responses. With cadaver testing that is often employed in the industry, the changing of the specimen over time can cloud results. Our mechanical model ensures we are correctly evaluating the reaction of the brace on the leg, not the leg's natural degeneration throughout the testing period.
Our in-house ACL surrogate uses pneumatically actuated cables to simulate various states of the human knee, from the swing phase of gait, with very little load going through a joint, or coming off a jump, where a great deal of compressive load will be forced across the joint. We can further manipulate the ACL cable to replicate common sports injuries. We can see how the much the tibia moves without the brace, then repeat the test after putting the brace on and look for a reduction in the tibial translation..
Just as important as our work in the lab is our commitment to clinical research. Most limb orthosis products (e.g. knee braces) are FDA Class I devices, exempt from FDA 510k or Premarket Approval requirements. As such, the barrier to entry into the limb orthotics market is low. Consequently, today’s limb orthotics market is saturated with devices and manufacturers. This crowded market has led to ‘a brace is a brace’ mentality amongst professionals, where practitioners do not see a clinical or biomechanical difference between products on the market.
It is our commitment that we do not foster this type of mentality. Through collaboration with clinical and biomechanics institutions around the world, we are determined to investigate the efficacy of our products. Our support of clinical research is performed in an unbiased, independent fashion. We collaborate with highly reputable institutions, such as the University of Vermont, to study our products. We strive to conduct randomized, controlled trials, where the patients are randomly assigned to an active or placebo treatment. In these clinical investigations, patients are enrolled in a study, and their clinical outcomes are quantified. In many cases, both clinical outcomes and biomechanical outcomes (e.g. gait analysis) are obtained.