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Pre-Operative Assessment of Fusion-Related Bone Failure

Award Number: R43AR064613
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2014
PERIOD OF PERFORMANCE END DATE: 06/30/2016

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Pre-Operative Assessment of Fusion-Related Bone Failure - DESCRIPTION (provided by applicant): With over 400,000 patients undergoing spine fusion surgery each year, many of whom have low bone density because of their advanced age, it is now clear that failure of the bone after a fusion procedure is a serious and increasingly common problem. This negative outcome of the primary fusion surgery requires the patient have a second surgery, and arises because the patient's vertebral bone is too weak to sustain the loads applied to it after the primary fusion surgery. The bone can fail in different ways, the most common modes of bone failure being: 1) fracture of the adjacent-level vertebra; 2) loosening of a pedicle screw due to local failure of the supporting bone; and 3) subsidence or fracture of the vertebral endplates. These failure modes have been difficult to avoid because, although spine surgeons have a variety of both surgical and non-surgical approaches to reduce the risk of bone failure, these risk-mitigating measures add complexity and expense to the surgery and surgeons do not have an objective test to justify their use or identify which measures would be most suitable for a given high-risk patient. Thus, in the larger context of minimizing the incidence of bone failure after a spine fusion surgery, the long-term goal of this overall SBIR project is to develop new clinical tests that: 1) pre-operatively identify patients at high-risk of bone failure secondary to a fusion surgery; and 2) assess risk for each potential mode of bone failure (fracture of the adjacent-level vertebra; loosening of a pedicle screw; subsidence or fracture of the vertebral endplates). Our overall approach is based on providing a detailed biomechanical analysis of the patient's vertebrae, performed as an "add-on" analysis of the patient's pre-operative diagnostic computed tomography (CT) scan of their spine. For this Phase-I portion of the project, Aim 1 will develop a set of "virtual stress tests" of the patient's vertebrae, using fnite element analysis of the patient's CT scan. These biomechanical tests will probe each of the different types of failure modes and will account also for patient-specific measures of spine curvature and loading as well as disc morphology. These multiple tests will then be used in Aim 2, in which we will perform a retrospective blinded case-control study on over 300 spine fusion patients, for whom pre-operative CT scans have previously been acquired and clinical outcomes are on file. Finally, in Aim 3, we will perform statistical analyses to identify which of the test outcomes are most predictive of the clinical outcomes, accounting also for various clinical risk factors. We also seek to test the hypothesis that prediction of clinical outcomes by our biomechanics-based test is better than by the current best practices, setting the stage for further development of the technology in a subsequent Phase-II project. Bone failure secondary to spine fusion surgery is a serious problem. If successful, these new tests would be cost-effective to implement and would have substantial positive impact on patient care.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2014	O N DIAGNOSTICS LLC	2150 SHATTUCK AVE STE 610	BERKELEY	CA	94704	ALAMEDA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	11/3/2016	NEW	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $225,000 )
2014	2014	O N DIAGNOSTICS LLC	64 SHATTUCK SQUARE	BERKELEY	CA	94704	ALAMEDA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/16/2014	NEW	$225,000
														Subtotal = $225,000

Grand Total All Awards = $225,000

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Pre-Operative Assessment of Fusion-Related Bone Failure

Award Number: R43AR064613

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/16/2014

PERIOD OF PERFORMANCE END DATE: 06/30/2016

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