Abstract

BackgroundCurrently there are no standard models with which to evaluate the biomechanical performance of calcified tissue adhesives, in vivo. We present, herein, a pre-clinical murine distal femoral bone model for evaluating tissue adhesives intended for use in both osseous and osteochondral tissue reconstruction.ResultsCylindrical cores (diameter (Ø) 2 mm (mm) × 2 mm depth), containing both cancellous and cortical bone, were fractured out from the distal femur and then reattached using one of two tissue adhesives. The adhesiveness of fibrin glue (Tisseeltm), and a novel, biocompatible, calcium phosphate-based tissue adhesive (OsStictm) were evaluated by pullout testing, in which glued cores were extracted and the peak force at failure recorded. The results show that Tisseel weakly bonded the metaphyseal bone cores, while OsStic produced > 30-fold higher mean peak forces at failure (7.64 Newtons (N) vs. 0.21 N). The failure modes were consistently disparate, with Tisseel failing gradually, while OsStic failed abruptly, as would be expected with a calcium-based material. Imaging of the bone/adhesive interface with microcomputed tomography revealed that, for OsStic, failure occurred more often within cancellous bone (75% of tested samples) rather than at the adhesive interface.ConclusionsDespite the challenges associated with biomechanical testing in small rodent models the preclinical ex-vivo test model presented herein is both sensitive and accurate. It enabled differences in tissue adhesive strength to be quantified even for very small osseous fragments (<Ø4mm). Importantly, this model can easily be scaled to larger animals and adapted to fracture fragment fixation in human bone. The present model is also compatible with other long-term in vivo evaluation methods (i.e. in vivo imaging, histological analysis, etc.).

Highlights

  • There are no standard models with which to evaluate the biomechanical performance of calcified tissue adhesives, in vivo

  • Powder was added to Bostic Rapid during curing, at varied weight percentages, and the peak curing temperature decreased from 120 degrees Centigrade (°C) to < 55 °C degrees

  • The present biomechanical test model represents the first report of an ex vivo model using murine bone that is sensitive enough to detect bone tissue adhesive strength, between two different types of tissue adhesives

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Summary

Introduction

There are no standard models with which to evaluate the biomechanical performance of calcified tissue adhesives, in vivo. Osteochondral bone fragments can impede (2019) 1:11 bond to weak or osteoporotic bone surfaces, facilitate realignment and fixation of tissue fragments and reduce surgical time [9], facilitate early load bearing, and avoid detrimental stress related effects [8, 10,11,12]. An example of a synthetic adhesive approach is a thiol-ene chemistry fracture repair model in rats, which can attain shear strengths up to 9 MPa ex vivo [14]. Another synthetic bone cement branded Kryptonite was Food and Drug Administration (FDA) approved for cranioplasty in 2009 [21, 22]. This product was abruptly removed from all markets following an FDA class 2 worldwide voluntary recall notice in April 2012

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