Background context: While the clinical effectiveness of recombinant human Platelet Derived Growth Factor‐B chain homodimer combined with collagen and β‐tricalcium phosphate (rhPDGF‐BB + collagen/β‐TCP) treatment for indications involving hindfoot and ankle is well‐established, it is not approved for use in spinal interbody fusion, and the use of autograft remains the gold standard.Purpose: The purpose of this study was to compare the effects of rhPDGF‐BB + collagen/β‐TCP treatment on lumbar spine interbody fusion in an ovine model to those of autograft bone and collagen/β‐TCP treatments using biomechanical, radiographic, and histological assessment techniques.Study design: Thirty‐two skeletally mature Columbian Rambouillet sheep were used to evaluate the safety and effectiveness of rhPDGF‐BB + collagen/β‐TCP matrix in a lumbar spinal fusion model. Interbody polyetheretherketone (PEEK) cages contained either autograft, rhPDGF‐BB + collagen/β‐TCP, collagen/β‐TCP matrix, or left empty.Methods: Animals were sacrificed 8‐ or 16‐weeks post‐surgery. Spinal fusion was evaluated via post‐sacrifice biomechanical, micro‐computed tomography (μCT), and histological analysis. Outcomes were statistically compared using a two‐way analysis of variance (ANOVA) with an alpha value of 0.05 and a Tukey post‐hoc test.Results: There were no statistically significant differences between groups within treatment timepoints for flexion‐extension, lateral bending, or axial rotation range of motion, neutral zone, neutral zone stiffness, or elastic zone stiffness. μCT bone volume fraction was significantly greater between treatment groups independent of timepoint where Autograft and rhPDGF‐BB + collagen/β‐TCP treatments demonstrated significantly greater bone volume fraction as compared to collagen/β‐TCP (P = .026 and P = .038, respectively) and Empty cage treatments (P = .002 and P = .003, respectively). μCT mean bone density fraction was most improved in rhPDGF‐BB + collagen/β‐TCP specimens at the 8 week and 16‐week timepoints as compared to all other treatment groups. There were no statistically significant differences in histomorphometric measurements of bone, soft tissue, or empty space between rhPDGF‐BB + collagen/β‐TCP and autograft treatments.Conclusions: The results of this study indicate that the use of rhPDGF‐BB combined with collagen/β‐TCP promotes spinal fusion comparable to that of autograft bone.Clinical significance: The data indicate that rhPDGF‐BB combined with collagen/β‐TCP promotes spinal fusion comparably to autograft bone treatment and may offer a viable alternative in large animal spinal fusion. Future prospective clinical studies are necessary to fully understand the role of rhPDGF‐BB combined with collagen/β‐TCP in human spinal fusion healing.

Background: The use of intervertebral cages within the interbody fusion setting is ubiquitous. Synthetic cages are predominantly manufactured using materials such as Ti and PEEK. With the advent of additive manufacturing techniques, it is now possible to spatially vary complex 3D geometric features within interbody devices, enabling the devices to match the stiffness of native tissue and better promote bony integration. To date, the impact of surface porosity of additively manufactured Ti interbody cages on fusion outcomes has not been investigated. Thus, the objective of this work was to determine the effect of implant endplate surface and implant body architecture of additive manufactured lattice structure titanium interbody cages on bony fusion.Methods: Biomechanical, microcomputed tomography, static and dynamic histomorphometry, and histopathology analyses were performed on twelve functional spine units obtained from six sheep randomly allocated to body lattice or surface lattice groups.Results: Nondestructive kinematic testing, microcomputed tomography analysis, and histomorphometry analyses of the functional spine units revealed positive fusion outcomes in both groups. These data revealed similar results in both groups, with the exception of bone‐in‐contact analysis, which revealed significantly improved bone‐in‐contact values in the body lattice group compared to the surface lattice group.Conclusion: Both additively manufactured porous titanium cage designs resulted in increased fusion outcomes as compared to PEEK interbody cage designs as illustrated by the nondestructive kinematic motion testing, static and dynamic histomorphometry, microcomputed tomography, and histopathology analyses. While both cages provided for similar functional outcomes, these data suggest boney contact with an interbody cage may be impacted by the nature of implant porosity adjacent to the vertebral endplates.

In vivo bioreactors are a promising approach for engineering vascularized autologous bone grafts to repair large bone defects. In this pilot parametric study, we first developed a 3D printed scaffold uniquely designed to accommodate inclusion of a vascular bundle and facilitate growth factor delivery for accelerated vascular invasion and ectopic bone formation. Second, we established a new sheep deep circumflex iliac artery (DCIA) model as an in vivo bioreactor for engineering a vascularized bone graft and evaluated the effect of implantation duration on ectopic bone formation. Third, after 8 weeks of implantation around the DCIA, we transplanted the prevascularized bone graft to a 5 cm segmental bone defect in the sheep tibia, using the custom 3D printed BMP-2 loaded scaffold without prior in vivo bioreactor maturation as a control. Analysis by micro-computed tomography and histomorphometry found ectopic bone formation in BMP-2 loaded scaffolds implanted for 8 and 12 weeks in the iliac pouch, with greater bone formation occurring after 12 weeks. Grafts transplanted to the tibial defect supported bone growth, mainly on the periphery of the graft, but greater bone growth and less soft tissue invasion was observed in the avascular BMP-2 loaded scaffold implanted directly into the tibia without prior in vivo maturation. Histopathological evaluation noted considerably greater vascularity in the bone grafts that underwent in vivo maturation with an inserted vascular bundle compared to the avascular BMP-2 loaded graft. Our findings indicate that use of an initial DCIA in vivo bioreactor maturation step is a promising approach to developing vascularized autologous bone grafts, although scaffolds with greater osteoinductivity should be further studied.

Studies of head, neck, and cervical spine morphology and tissue material properties indicate that cervical spine biomechanics differ between adult males and females. These differences result in sex-specific cervical spine kinematics and injury patterns in response to standardized loading conditions. Because direct laryngoscopy and endotracheal intubation require the application of a load to the cervical spine, intubation biomechanics should be sex-specific. The aim of this study was to determine if intubation forces during direct laryngoscopy differ between male and female patients and, if so, is the difference independent of body weight. We pooled original data from three previously published adult clinical intubation studies that used methodologically reliable intubation force measurements (measured total laryngoscope force applied to the tongue, and force values were insensitive to or accounted for other laryngoscope blade forces). All patients had undergone direct laryngoscopy and orotracheal intubation with a Macintosh 3 blade under general anesthesia. Patient data included sex, age, height, weight, and maximum intubation force. Least squares multivariable linear regression was performed between the dependent variable (maximum intubation force) and two independent variables (patient sex and patient weight). A third term was added for the interaction between patient sex and weight. Among all patients (males n=42, females n=59), the median intubation force was 42.2 N (25^th to 75^th percentiles: 31.5 to 57.4 N). While controlling for patient body weight, intubation force differed between the sexes; P=0.011, with greater intubation force in male patients. While controlling for patient sex, there was a positive association between patient body weight and intubation force; P=0.009. In addition, there was a significant interaction between patient sex and weight; P=0.002, with intubation force in male patients having greater dependence on body weight. The difference in intubation force between male and female patients who had the same body weight exceeded 5 N when body weight exceeded 75 kg, and intubation force differences between male and female patients increased as patient body weight increased. Additional analyses using robust regression and using body mass index instead of weight provided comparable results. In adult patients, the biomechanics of direct laryngoscopy and intubation are sex-specific. Our findings support the need to control for patient sex and weight in future clinical and laboratory studies of the human cervical spine and head and neck biomechanics.

OBJECTIVEBecause of limitations inherent to cadaver models of endotracheal intubation, the authors’ group developed a finite element (FE) model of the human cervical spine and spinal cord. Their aims were to 1) compare FE model predictions of intervertebral motion during intubation with intervertebral motion measured in patients with intact cervical spines and in cadavers with spine injuries at C-2 and C3–4 and 2) estimate spinal cord strains during intubation under these conditions.METHODSThe FE model was designed to replicate the properties of an intact (stable) spine in patients, C-2 injury (Type II odontoid fracture), and a severe C3–4 distractive-flexion injury from prior cadaver studies. The authors recorded the laryngoscope force values from 2 different laryngoscopes (Macintosh, high intubation force; Airtraq, low intubation force) used during the patient and cadaver intubation studies. FE-modeled motion was compared with experimentally measured motion, and corresponding cord strain values were cal...