Abstract
ABSTRACTCurrent pharmaceutical therapies can reduce hip fractures by up to 50%, but compliance to treatment is low and therapies take up to 18 months to reduce risk. Thus, alternative or complementary approaches to reduce the risk of hip fracture are needed. The AGN1 local osteo‐enhancement procedure (LOEP) is one such alternative approach, as it is designed to locally replace bone lost due to osteoporosis and provide immediate biomechanical benefit. This in vitro study evaluated the initial biomechanical impact of this treatment on human cadaveric femurs. We obtained 45 pairs of cadaveric femurs from women aged 77.8 ± 8.8 years. One femur of each pair was treated, while the contralateral femur served as an untreated control. Treatment included debridement, irrigation/suction, and injection of a triphasic calcium‐based implant (AGN1). Mechanical testing of the femora was performed in a sideways fall configuration 24 h after treatment. Of the 45 pairs, 4 had normal, 16 osteopenic, and 25 osteoporotic BMD T‐scores. Altogether, treatment increased failure load on average by 20.5% (p < 0.0001). In the subset of osteoporotic femurs, treatment increased failure load by 26% and work to failure by 45% (p < 0.01 for both). Treatment did not significantly affect stiffness in any group. These findings provide evidence that local delivery of the triphasic calcium‐based implant in the proximal femur is technically feasible and provides immediate biomechanical benefit. Our results provide strong rationale for additional studies investigating the utility of this approach for reducing the risk of hip fracture. © 2019 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society.
Highlights
Osteoporosis, characterized by compromised bone strength leading to an increased fracture risk, impacts over 200 million women worldwide.[1,2] Hip fractures are the most devastating fractures, leading to increased mortality and morbidity
This study evaluated a new minimally invasive approach intended to strengthen the hip by addressing local osteoporotic bone loss by delivering a resorbable, triphasic calcium sulfate/calcium phosphate implant material (AGN1) to the proximal femur
The treated group was injected with the triphasic calcium sulfate/ calcium phosphate self-setting implant material and the contralateral femurs were left as the untreated control group
Summary
Osteoporosis, characterized by compromised bone strength leading to an increased fracture risk, impacts over 200 million women worldwide.[1,2] Hip fractures are the most devastating fractures, leading to increased mortality and morbidity. The vast majority of hip fractures occur subsequent to a fall, a fall to the side with impact to the hip.[9] While currently available pharmaceutical treatments improve proximal femur bone mineral density (BMD), they can take up to 18 months to significantly reduce the risk of fracture.[10] Available pharmaceutical therapies provide up to an approximately 50% reduction in hip fractures,[11,12] but patient compliance is about 50% after 1 year.[13,14] Anabolic therapies, such as teriparatide, abaloparatide, and romozosumab, stimulate new bone formation and can lead to significant increases in BMD.[15,16,17] these medications are delivered via subcutaneous injection and have patient compliance issues with. The intervention must not increase the immediate risk of hip fracture and must provide long-term fracture risk reduction, and if a subsequent fracture does occur, the intervention should not interfere with a standard approach for fracture repair
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