Osseosurface Electronics to Monitor Rehabilitation and Accelerate Return to Duty Following Surgical Treatment of Long Bone Fractures
Abstract
Focus Areas: Despite recent advances in fracture treatment, we are currently unable to accurately measure fracture healing in patients. Radiographs (X-rays) are used to monitor healing, but only demonstrate healing after it has occurred, cannot be performed daily due to the need for specialized equipment, and expose patients to radiation with long-term health consequences. Healing is unpredictable, and the inability to measure real-time fracture healing delays rehabilitation and return to duty in most patients, which is limited by the slowest healers. Our group is developing technology that accurately measures fracture healing in real-time. Continuous objective measurements of fracture healing will allow clinicians to accelerate rehabilitation allow early return to duty. The current proposal focuses on Retention Strategies to Facilitate Return to Duty, Enable Decision Support Tools, Diagnostic Capabilities, and Avoiding Reinjury. The proposal will test novel implantable wireless, battery-free electronics that permanently bond to bone, and provide multimodal sensing capabilities. The implants will be tested in a large animal fracture model as a tool to measure fracture healing and monitor rehabilitation. The primary goal of this technology is to provide a point-of-care technology that continuously monitors fracture healing and bone health throughout the entire treatment process from the time of surgery, through healing, rehabilitation, and following re-deployment to the battlefield. The technology is being developed in conjunction with wearables incorporated into standard military uniforms that allow for continuous power and readout of the implantable devices without the need for additional specialized equipment. The implantable sensors will also be used to monitor bone regeneration in large bone defects that typically lead to amputation. The defects will be treated using 3D-printed biomimetic scaffolds and stem cells isolated from a patient s own fat tissue. Potential Research and Clinical Applications: The goal of current fracture management is skeletal stabilization to allow patient rehabilitation through mobilization that accelerates soft tissue recovery during bone healing. We have no method to measure fracture healing in real-time, which limits rehabilitation and return-to-duty protocols to the slowest healers. The immediate clinical benefit of our technology is to enable real-time continuous objective measurements of bone healing and allow clinicians to individualize and maximize rehabilitation protocols, accelerate return to duty, and ensure the best outcome for each patient. The technology will also allow for continued monitoring following redeployment in the battlefield to minimize the risk of reinjury. While the current proposal focuses on fracture healing and rehabilitation, there are numerous additional clinical and research applications of our implantable electronics. These include a means of early detection of infection, a tool to provide neuromuscular feedback in composite tissue regeneration, and a tool to monitor long-term bone health and treatment in metabolic bone diseases such as osteoporosis. Projected Time to Achieve a Clinically Relevant Outcome: The electronic components of our implant are produced using materials that meet United States Pharmacopeia (USP) class VI and/or International Standards Organization (ISO) 10993-5 standards for implantable materials. While the final product would need to demonstrate safety and efficacy prior to U.S. Food and Drug Administration (FDA) approval, exclusive use of thoroughly tested non-toxic implantable components will minimize the cost and effort needed to demonstrate safety and efficacy. The electronics are powered and read using radiofrequency waves approved under FDA guidelines. The experiments completed in this proposal will prepare this technology for a clinical trial, which will potentially directly benefit service personnel immedi
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310233
Entities
People
- David Margolis
Organizations
- United States Army
- University of Arizona