DEVELOPMENT OF HIGHLY FUNCTIONAL, NEURALLY CONTROLLED, SKELETALLY ATTACHED, AND INTELLIGENT PROSTHETIC DEVICES
DOD 07/22/2015 – 07/21/2018 $4,520,888
Principal Investigators: Kent Bachus, PhD; Charles Saltzman, MD
Co-Investigators: Roy Bloebaum, PhD; James Beck, MD; Robert Tashjian, MD; Heath Henhinger, PhD; Erik Kubiak, MD
The overall goal of this 3-year research project will be to engineer and develop AEA PODS devices ready for translation to human clinical trials. This will include appropriate surgical procedures, instrumentation, and a series of AEA PODS devices required to fit a population of AEA patients with the diversity of personnel currently serving active duty for the United States or receiving treatment within either military or the VA healthcare systems. We will first engineer AEA PODS devices to successfully fit the AEA patient population. Second, we will verify the design and manufacturing processes for the AEA PODS devices. Third, we will establish the design history file and the FDA regulatory pathway required to bring AEA PODS devices to clinical trial.
INVESTIGATION OF A TRANSLATABLE ANIMAL MODEL IN ORDER TO UNDERSTAND THE ETIOLOGY OF HETEROTOPIC OSSIFICATION
DOD/USUHS 09/01/2017 – 03/31/2021 $2,219,531
Principal Investigator: Dustin Williams, PhD
Co-Investigators: Ryan Looper, PhD; David Rothberg, MD; Travis Hauussener, PhD
Wounded warriors who return from Iraq and Afghanistan often suffer from traumatic injuries that result in skin wounds and/or bone damage. Bone damage in those soldiers who suffer amputations can lead to a problem that is referred to as heterotopic ossification, which means that bone growth sprouts away from a long bone and into a soldier’s muscle. This can be painful and no one yet knows exactly why it forms or how to stop it. We are developing models to answer these questions. Skin wounds can also be a problem, in particular with infection. Negative pressure wound therapy is a common method of treatment, but there are very limited options when it comes to selecting materials that can treat or prevent infection in these skin wounds. We are developing a special type of antimicrobial dressing that can be used in negative pressure wound therapy to address this problem as well.
THE INFLUENCE OF AN EXPANDED BUNDLED PAYMENT PROGRAM ON PATIENT-REPORTED OUTCOMES, EPISODE-OF-CARE COSTS, PROCEDURE VOLUME, AND SAFETY
HHS AHRQ 03/01/2017 – 02/28/2021 $1,416,156
Principal Investigator: Brook Martin, PhD
Co-Investigators: Christopher Pelt, MD; Richard Nelson, PhD
Medicare is starting a new way to pay hospitals when patients replace a hip or knee joint. A ‘bundled payment” is one charge for all health care occurring within 90 days of when a joint is replaced. We will study how hospitals are preparing for the new way of being paid, and how the change affects patient safety and well being.
DEVELOPMENT OF A UNIQUE ANTIBIOFILM THERAPY FOR DIABETIC FOOT ULCER INFECTIONS
VA 10/01/2016 – 09/30/2020 $1,099,915
Principal Investigator: Dustin Williams, PhD
Co-Investigators: Ryan Looper, PhD; Laurence Meyer, PhD, MD; Donald Granger, MD
The immediate objective of this project is to test the efficacy of an innovative antibiofilm therapy to treat and prevent biofilm-related infection in a diabetic pig excision wound model. Long-term, the objective is to translate this technology for testing CZs in the clinic.
INVESTIGATION OF A TRANSLATABLE ANIMAL MODEL IN ORDER TO UNDERSTAND THE ETIOLOGY OF HETEROTOPIC OSSIFICATION
Henry M. Jackson Foundation/CRSR 08/01/2016 – 08/14/2018 $843,650
Principal Investigator: Dustin Williams, PhD
Co-Investigators: Brad Isaacson, PhD
The objective of this grant is to develop a translatable model of HO formation in sheep. More specifically, this study will combine factors including a simulated blast, tourniquet, bacterial presence and wound vac usage to determine if they contribute collectively to HO formation.
PERCUTANEOUS OSSEOINTEGRATED DOCKING SYSTEM FOR ABOVE ELBOW AMPUTEES
VA 11/01/2014 – 10/31/2017 $814,600
Principal Investigator: Kent Bachus, PhD
The overall goal of this three-year project is to develop intramedullary Percutaneous Osseointegrated Docking System (PODS) devices for patients with above elbow amputations (AEA), ready for translation to human clinical trials. The AEA PODS device will address not only the challenges found in above elbow residual limbs of modern day warfighters (i.e. short residual limbs, heterotopic ossification (HO), shrapnel), but also develop clinical strategies to establish and to maintain the dermal seal between the periprosthetic tissues and the PODS device. Using our established protocols used to develop endoprosthesis for previous sheep animal models and upcoming FDA Feasibility trials for AKA PODS devices, we will engineer a series of AEA PODS sufficient to achieve a 95% confidence of fitting a sample AEA patient population and develop a mathematical relationship to estimate, within 95% confidence, the initial post-operative fixation of AEA PODS given the endoprosthetic fit.
NEGATIVE PRESSURE WOUND THERAPY TO SOFT TISSUES SURROUNDING PERCUTANEOUS DEVICES
VA 05/01/2015 – 04/30/2018 $812,700
Principal Investigator: Kent Bachus, PhD
Co-Investigators: Sujee Jeyapalina, PhD
The overall goal of this three-year project is to maximize the functional recovery of patients with amputated limbs by establishing and maintaining a non-migratory biological seal between the periprosthetic tissues and the percutaneous osseointegrated docking system (PODS) device. Our previous work indicates that the periprosthetic tissues surrounding these PODS devices show a chronic wound healing response and migrate along the percutaneous interface, a process known as down growth. Clinically, chronic wounds are often closed using a technique known as Negative Pressure Wound Therapy (NPWT). We will first determine if NPWT can inhibit the down growth and subsequent infection of the periprosthetic tissues surrounding PODS devices. Second, we will establish whether NPWT is required to maintain the biological seal over time. Third, in the presence of a gap between the periprosthetic tissues and the PODS device, we will determine whether NPWT can re-establish the biological seal between the periprosthetic tissues and the PODS device.
A COMBINATION COATING FOR THE PREVENTION OF PERIOPERATIVE DEVICE INFECTIONS
VA 12/01/2014 – 11/30/2017 $796,494
Principal Investigator: Dustin Williams, PhD
Co-Investigators: Roy Bloebaum, PhD; James Beck, MD; John Hibbs, MD
The goal of this work is to provide a unique approach to address the current limitations of conventional antibiotic therapies utilizing synthetic molecules and controlled release for the prevention of perioperative device related infections in the VA patient population.
SAFETY STUDY OF PERCUTANEOUS OSSEOINTEGRATED IMPLANTS FOR PROSTHETIC ATTACHMENT
VA 10/1/2013 – 03/31/2018 $537,000
Principal Investigator: Sarina Sinclair, PhD
Co-Investigators: N/A
This study will test a novel percutaneous osseointegrated prosthetic implant for transfemoral amputees as an alternative to a socket prosthetic limb attachment system. This work aims to address the complications associated with socket technology with a device that is implanted directly into the residual bone and can be used to improve the quality of life for Veterans amputees.
INVESTIGATION OF A TRANSLATABLE ANIMAL MODEL IN ORDER TO UNDERSTAND THE ETIOLOGY OF HETEROTOPIC OSSIFICATION
Henry M. Jackson Foundation/CRSR 07/01/2016 – 06/30/2018 $377,916
Principal Investigators: Dustin Williams, PhD
Co-Investigators: Brad Isaacson, PhD
The objective of this grant is to develop a translatable model of HO formation in sheep. More specifically, this study will combine factors including a simulated blast, tourniquet, bacterial presence and wound vac usage to determine if they contribute collectively to HO formation.
POLYAMINES AS UNIQUE TOPICAL WOUND THERAPIES TO TREAT BIOFILM RELATED INFECTIONS OF DECUBITUS ULCERS AND PRESSURE SORES
Henry M. Jackson Foundation/CRSR 04/01/2015 – 03/31/2018 $290,309
Principal Investigators: Dustin Williams, PhD
Co-Investigators: Brad Isaacson, PhD
This study will specifically assess the efficacy a unique first-in-class series of antibiofilm antibiotic as a standalone and combinatorial therapy to treat and prevent infections that accompany decubitis ulcer/pressure sore formation in wounded soldiers.
NSC-FO: SENSORY-MOTOR INTEGRATION VIA RECORDING AND STIMULATING ARM NERVES
NSF 08/01/2015 – 07/31/2018 $127,094
Principal Investigators: Greg Clark, PhD; Douglas Hutchinson, MD; V. John Mathews, PhD
Co-Investigators: N/A
The goal of this project is to understand how to best utilize all of the available motor and sensory information in the design of accurate neural controllers for future generations of forearm prostheses. The specific goals of the project are to: (a) identify components in peripheral nerve signals that correlate with errors between the intended movement and the actual movement of the prosthetic arm through data-driven models, and to use this information to control the prosthetic hand; (b) develop accurate encoders and stimulation systems that provide punctate, naturalistic, multimodal, and graded sensory percepts; and (c) develop, characterize, and evaluate advanced decoders that estimate movement intent from a combination of peripheral nerve signals and sensory information from the prosthesis. The result of the last item, an advanced decoder, will be evaluated with scenarios that provide clear measures of performance and scenarios that represent activities of daily living. The integrated approach to creating sensory percepts and interpreting motor intent is expected to recreate the natural, minimally monitored use of a prosthetic hand in volunteers to interact more effectively with their world.
EMBODIED PROSTHESIS
DOD 11/06/2014 – 02/28/2019 $122,460
DOD 11/06/2014 – 02/28/2019 $96,000
DOD 03/22/2016 – 02/28/2019 $94,110
DOD 03/22/2016 – 02/28/2019 $55,674
Principal Investigators: Greg Clark, PhD; Douglas Hutchinson, MD
Co-Investigators: N/A
This effort pursues fundamental research regarding technological developments and functional investigations to restore dexterous, intuitive motor function and cutaneous and proprioceptive sensory function after hand amputation. This work is spread across 3 technical areas. 1) Electrodes and Algorithms: Focus on improvements to Utah Slant Electrode Array; development of motor decode algorithms and sensory encode algorithms; plus associated IDE approvals. 2) Electronics and Packaging: Animal physiological tests of device(s) to be supplied by other HAPTIX performers, plus histological assessments for IDE/FDA approval; integration of electrodes and algorithms with 3rd-party electronics from other HAPTIX performers. 3) Human Use Testing: Evaluation of technology in functional tests in human subjects; plus associated IDE approvals.
IMPROVING PAIN MANAGEMENT AND LONG TERM OUTCOMES FOLLOWING HIGH ENERGY ORTHOPEDIC TRAUMA (PAIN STUDY)
Johns Hopkins University 11/01/2013 – 09/28/2018 $21,578
Principal Investigators: Thomas Higgins, MD