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Osteotomy-Free Correction Of Acetabular Dysplasia: Characterization and Proper Patient Selection for the SHALE Procedure

Award Number: R01AR088036
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: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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Osteotomy-Free Correction Of Acetabular Dysplasia: Characterization and Proper Patient Selection for the SHALE Procedure - Project Summary Dysplasia of the hip joint affects an estimated six million adults in the US, accounting for an estimated 10% (35,000 annual) of all Total Hip Arthroplasties (THA) and up to 48% of THA performed in patient <50 years of age in the United States2. At an estimated cost of $39,0000, this single diagnosis costs the US healthcare system over $1.3 billion annually. While not fatal, failure to treat can lead to chronic pain and disability. Current surgical treatments are reactive, relying on osteotomies that cut the pelvis bones and re-orient the misshapen hip socket or to internally amputating the hip joint and replacing it with mechanical prostheses with limited lifespans, thus ignoring the opportunity during skeletal growth to improve acetabular coverage through pelvic growth modulation. The objective of the current application is to characterize the effects that a novel, minimally invasive pelvic growth modulation strategy has on acetabular coverage while identifying patients who would most benefit from this therapeutic approach. We will accomplish this through the following aims: Aim 1: To measure typical and SHALE induced acetabular form and function during skeletal development the swine model. Hypothesis: The effects of SHALE can be titrated, the correction will be permanent, and it will lead to no significant changes in functional hip range of motion (ROM) or parturition. Approach: Growth, 3D-shape, and SHALE dose will be measured using discrete measurements, statistical shape modeling (SSM), motion capture, and parturition. Impact: Increased fundamental knowledge of pelvic development and function combined with validation and dose-response effects of the SHALE procedure. Aim 2: To comprehensively characterize the 3D acetabular deficiency in DDH, CP, and SMA. Hypothesis: Unique patterns of acetabular deficiency will be found according to patient diagnosis, age, and ambulatory status. Approach: A validated software platform (VirtualHip) will be used to comprehensively assess detail morphological features of the hip in large group of patients (DDH, CP and CP) treated at three, high volume, tertiary care pediatric orthopedic practices. Impact: Improved understanding of patient-related 3D dysplasia patterns that will immediately improve current treatments and will be critical for SHALE clinical translation. Aim 3: To compare the patterns of pelvis development between the swine model and human subjects to facilitate translation of our preclinical observations into a clinical trial. Premise: While the human and porcine pelvis are similar, differences in growth and geometry are not well described, but necessary to understand the SHALE effects in humans. Approach: Develop a porcine module (conversion tool) for the Virtual Hip platform using longitudinal CT scans of swine pelvis throughout postnatal development to track changes in the relative 3D positions of anatomic landmarks comparing these findings with Virtual Hip human controls to facilitate construction of the conversion tool. Impact: Creation of a powerful tool for future preclinical hip research that will simulate SHALE-induced changes onto the human pelvis prior to clinical trial.


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: 2026 ( Subtotal = $715,778 )
2026	2026	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/9/2026	NEW	$715,778
														Subtotal = $715,778

Grand Total All Awards = $715,778

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Osteotomy-Free Correction Of Acetabular Dysplasia: Characterization and Proper Patient Selection for the SHALE Procedure

Award Number: R01AR088036

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: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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