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. 2019 Apr;37(4):908-915.
doi: 10.1002/jor.24239. Epub 2019 Mar 20.

In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity

John D Stroncek  1 , Jonathan L Shaul  1 , Dominique Favell  1 , Ronald S Hill  1 , Bryan M Huber  2 , James G Howe  1 , Mary L Bouxsein  3
Affiliations

In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity

John D Stroncek et al. J Orthop Res. 2019 Apr.

Erratum in

Abstract

Current 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.

Keywords: bone aging; bone mechanics and finite element analysis; bone tissue engineering and repair.

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Figures

Figure 1
Figure 1
A rendering of AGN1 injection procedure into the proximal femur. A 2.5 mm guide pin was inserted into the femoral neck (A), a 5.3 mm cannulated drill was inserted over the guide pin (B), the implant site was manually debrided to loosen fat and marrow (C) which was removed with irrigation and suction, and the implant material was injected into the proximal femur (D).
Figure 2
Figure 2
Schematic of mechanical testing set up.
Figure 3
Figure 3
Pre‐ and post‐treatment CT images of osteopenic paired femurs. Control (A), Treated before debridement and AGN1 injection (B), and after AGN1 injection (C).
Figure 4
Figure 4
AGN1 distribution in cadaveric femurs following treatment. Normal (A and B), Osteopenic (C and D), and Osteoporotic (E to I) femurs.
Figure 5
Figure 5
Failure load (A), work to failure (B), and stiffness (C) of all femurs and femurs stratified by femoral neck BMD T‐score: Osteoporotic (T‐score < −2.5), osteopenic (−1 to −2.5), and normal (T‐score > −1). Data presented as mean ± standard deviation; *Indicates p < 0.05 versus the paired control.
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