1.1 To translate our direct electromagnetic coupling (DEC) approach to the clinical milieu via rigorous development and investigation of the technology using multiple testing platforms. 1.2 Firmly establish the physical foundation of the DEC approach and optimize the system s hardware configuration for predicting the course of fracture healing. 1.3 Perform two large animal studies using the DEC approach in order to evaluate its efficacy for predicting the course of fracture healing 1.4 Perform a series of non-invasive patient studies that longitudinally follow specific fracture pattern cohorts in order to evaluate the DEC approach in a clinical setting. 1.5 Develop a telemedicine system wherein the DEC data can be collected by the patient and transmitted for analyses.
Screened patients will be briefed of the study protocol and if interested in participating in the study, will complete informed consent. During their regular follow-up visits, patients will have an antenna attached to their affected limb using velcro straps and stand on a flat platform that is configured with a load cell (i.e. digital scale). The patients will gradually shift their weight from the non-affected limb to the affected limb while a low energy and low frequency electromagnetic field is applied via the antenna. They will repeat the shifting of their weight 5 times to assure robust and repeatable data collection. The device will not be used to guide medical treatments and the effectiveness of the device will be measured against the current gold standard/standard of care for assessing fracture healing.More
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Medical Center of the Rockies
Protocol Number: 19-3107
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