Synthetic bone graft substitutes are commonly used in spinal fusion surgery. Preclinical data in a model of spinal fusion to support their efficacy is an important component in clinical adoption to understand how these materials provide a biological and mechanical role in spinal fusion. To evaluate the in vivo response of a nanosynthetic silicated calcium phosphate putty (OstP) combined with autograft compared to autograft alone or a collagen-biphasic calcium phosphate putty (MasP) combined with autograft in a rabbit spinal fusion model. Efficacy of a nanosynthetic silicated calcium phosphate putty as an extender to autograft was studied in an experimental animal model of posterolateral spinal fusion at 6, 9, 12 and 26 weeks, compared to a predicate device. Skeletally mature female New Zealand White rabbits (70) underwent single level bilateral posterolateral intertransverse process lumbar fusion, using either autograft alone (AG), a nanosynthetic silicated calcium phosphate putty (OstP) combined with autograft (1:1), or a collagen-biphasic calcium phosphate putty (MasP) combined with autograft (1:1). Iliac crest autograft was harvested for each group, and a total of 2 cc of graft material was implanted in the posterolateral gutters per side. Fusion success was assessed at all time points by manual palpation, radiographic assessment, micro-CT and at 12 weeks only using non-destructive range of motion testing. Tissue response, bone formation and graft resorption were assessed by decalcified paraffin histology and by histomorphometry of PMMA embedded sections. Assessment of fusion by manual palpation at the 12 week endpoint showed 7 out of 8 (87.5%) bilateral fusions in the OstP extender group, 4 out of 8 (50%) fusions in the MasP extender group, and 6 out of 8 (75%) fusions in the autograft alone group. Similar trends were observed with fusion scores of radiographic and micro-CT data. Histology showed a normal healing response in all groups, and increased bone formation in the OstP extender group at all timepoints compared to the MasP extender group. New bone formed directly on the OstP granule surface within the fusion mass while this was not a feature of the Collagen-Biphasic CaP material. After 26 weeks the OstP extender group exhibited 100% fusions (5 out of 5) by all measures, whereas the MasP extender group resulted in bilateral fusions in 3 out of 5 (60%), assessed by manual palpation, and fusion of only 20 and 0% by radiograph and micro-CT scoring, respectively. Histology at 26 weeks showed consistent bridging of bone between the transverse processes in the Ost P extender group, but this was not observed in the MasP extender group. The nanosynthetic bone graft substituted studied here, used as an extender to autograft, showed a progression to fusion between 6 and 12 weeks that was similar to that observed with autograft alone, and showed excellent fusion outcomes, bone formation and graft resorption at 26 weeks. This preclinical study showed that the novel nanosynthetic silicated CaP putty, when combined with autograft, achieved equivalent fusion outcomes to autograft. The development of synthetic bone grafts that demonstrate efficacy in such models can eliminate the need for excessive autograft harvest and results from this preclinical study supports their effective use in spinal fusion surgery.

Objective The aim of this study was to compare the interfragmentary compressive force and area of compression generated by cortical screws inserted as either a lag screw or position screw in simulated lateral humeral condylar fractures. Study Design Ex vivo biomechanical study. Materials and Methods Thirteen pairs of cadaveric humeri from skeletally mature Merinos with simulated lateral humeral condylar fractures were used. Pressure sensitive film was inserted into the interfragmentary interface prior to fracture reduction with fragment forceps. A cortical screw was inserted as a lag screw or a position screw and tightened to 1.8Nm. Interfragmentary compression and area of compression were quantified and compared between the two treatments groups at three time points. Results After fracture reduction using fragment forceps (Time point 1: T1), there was no significant difference in interfragmentary compression and area of compression between the two treatments. A combination of fragment forceps and a cortical screw inserted as a lag screw (Time point 2: T2) produced significantly greater interfragmentary compression and area of compression compared with the same screw inserted as a positional screw. After removal of the fragment forceps, leaving only the cortical screw (Time point 3: T3), both the interfragmentary compression and area of compression remain significantly greater in the lag screw group. Conclusion Lag screws generate a greater force of compression and area of compression compared with position screws in this mature ovine humeral condylar fracture model.

The interface and interactions between an interbody cage, graft material and host bone can all participate in the fusion. Shortcomings of PEEK interbody cages have been addressed with novel titanium surfaces. Titanium surfaces paired with macro-scale topography features on the endplates and within the aperture may provide additional benefits. To evaluate the influence of cage design parameters on interbody fusion in a large animal pre-clinical model. A comparative preclinical large animal model was performed to evaluate how macroscale topography features of an interbody cage can facilitate early integration between the host bone, graft material, and interbody cage and these effects on biomechanical stability and fusion. Forty single level interbody fusions (L4-5) using iliac crest autograft and bilateral pedicle screw fixation were performed in adult sheep to evaluate the effect of undercut macrostructure topography features of an interbody cage on the endplates and within the aperture. Fusions were evaluated at 6 and 12 weeks (n=10 per group) using radiography, microcomputed tomography, biomechanical integrity and histology endpoints. The presence of the undercut macrostructures present on the endplates and within the aperture statistically improved biomechanical integrity at 6 and 12 weeks compared to controls. Microcomputed tomography and histology demonstrated bony interdigitation within the endplate and aperture features contributing to the improvement in properties. The current study demonstrates that PEEK implants with titanium surfaces can be augmented by undercut macrostructures present on the endplates and within the aperture to provide opportunities for a series of anchoring points that, with new bone formation and remodelling, result in earlier and improved biomechanical integrity of the treated level. This preclinical study showed that bone interdigitation with the undercut macrostructures present on the endplates and within the aperture resulted in improved fusion and biomechanical stability in a clinically relevant spinal fusion model. Future clinical study is warranted to evaluate such implants' performance in humans.

Objectives The aim of this study was to report the use of computed tomography (CT) for postoperative evaluation of the accuracy of sacroiliac reduction and minimally invasive screw fixation in a series of five cats.Methods Medical records between January 2016 and March 2017 of cats presenting to the author's institution were reviewed. Included were cats that had undergone minimally invasive sacroiliac screw fixation with a complete medical record and pre- and postoperative radiographs. Screw size was obtained from the medical records. CT images were acquired prospectively and evaluated to assess joint reduction, relative screw size and screw positioning.Results Six sacroiliac luxations and 6 screws were available. Fixation was achieved with either a 2.4 (n = 1) or 2.7 mm (n = 5), 316L stainless steel, cortical bone screw. Mean screw size as a proportion of sacral diameter was 47.7%. Sacroiliac reduction >90% in the craniocaudal plane and sacral screw purchase >60% of the sacral width were achieved in 3/5 cases. Mean dorsoventral screw angulation was 1.6 degrees (range: −9.7 to 11.7 degrees) and craniocaudal angulation was −4.5 degrees (range: −16.6 to 6.6 degrees). Complications included screw loosening in the one case of bilateral repair and penetration of the neural canal in one case which was not detected with postoperative radiographic evaluation.Clinical Significance CT evaluation provides a useful method for the assessment of sacroiliac reduction and the accuracy of screw placement.

A biphasic calcium phosphate with submicron needle-shaped surface topography combined with a novel polyethylene glycol/polylactic acid triblock copolymer binder (BCP-EP) was investigated in this study. This study aims to evaluate the composition, degradation mechanism and bioactivity of BCP-EP in vitro, and its in vivo performance as an autograft bone graft (ABG) extender in a rabbit Posterolateral Fusion (PLF) model. The characterization of BCP-EP and its in vitro degradation products showed that the binder hydrolyses rapidly into lactic acid, lactide oligomers and unaltered PEG (polyethylene glycol) without altering the BCP granules and their characteristic submicron needle-shaped surface topography. The bioactivity of BCP-EP after immersion in SBF revealed a progressive surface mineralization. In vivo, BCP-EP was assessed in a rabbit PLF model by radiography, manual palpation, histology and histomorphometry up to 12 weeks post-implantation. Twenty skeletally mature New Zealand (NZ) White Rabbits underwent single-level intertransverse process PLF surgery at L4/5 using (1) autologous bone graft (ABG) alone or (2) by mixing in a 1:1 ratio with BCP-EP (BCP-EP/ABG). After 3 days of implantation, histology showed the BCP granules were in direct contact with tissues and cells. After 12 weeks, material resorption and mature bone formation were observed, which resulted in solid fusion between the two transverse processes, following all assessment methods. BCP-EP/ABG showed comparable fusion rates with ABG at 12 weeks, and no graft migration or adverse reaction were noted at the implantation site nor in distant organs.