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Bryan W. Cunningham, John C. Sefter, Nianbin Hu and Paul C. McAfee

Object

Using an in vivo caprine model, authors in this study compared the efficacy of autologous growth factors (AGFs) with autogenous graft for anterior cervical interbody arthrodesis.

Methods

Fourteen skeletally mature Nubian goats were used in this study and followed up for a period of 16 weeks postoperatively. Anterior cervical interbody arthrodesis was performed at the C3–4 and C5–6 vertebral levels. Four interbody treatment groups (7 animals in each group) were equally randomized among the 28 arthrodesis sites: Group 1, autograft alone; Group 2, autograft + cervical cage; Group 3, AGFs + cervical cage; and Group 4, autograft + anterior cervical plate. Groups 1 and 4 served as operative controls. Autologous growth factors were obtained preoperatively from venous blood and were ultra-concentrated. Following the 16-week survival period, interbody fusion success was evaluated based on radiographic, biomechanical, and histological analyses.

Results

All goats survived surgery without incidence of vascular or infectious complications. Radiographic analysis by 3 independent observers indicated fusion rates ranging from 9 (43%) of 21 in the autograft-alone and autograft + cage groups to 12 (57%) of 21 in the autograft + anterior plate group. The sample size was not large enough to detect any statistical significance in these observed differences. Biomechanical testing revealed statistical differences (p < 0.05) between all treatments and the nonoperative controls under axial rotation and flexion and extension loading. Although the AGF + cage and autograft-alone treatments appeared to be statistically different from the intact spine during lateral bending, larger variances and smaller relative differences precluded a determination of statistical significance. Histomorphometric analysis of bone formation within the predefined fusion zone indicated quantities of bone within the interbody cage ranging from 21.3 ± 14.7% for the AGF + cage group to 34.5 ± 9.9% for the autograft-alone group.

Conclusions

The results indicated no differences in biomechanical findings among the treatment groups and comparable levels of trabecular bone formation within the fusion site between specimens treated with autogenous bone and those filled with the ultra-concentrated AGF extract. In addition, interbody cage treatments appeared to maintain disc space height better than autograft-alone treatments.

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Bryan W. Cunningham, Nianbin Hu, Candace M. Zorn and Paul C. McAfee

Object

Using a synthetic vertebral model, the authors quantified the comparative fixation strengths and failure mechanisms of 6 cervical disc arthroplasty devices versus 2 conventional methods of cervical arthrodesis, highlighting biomechanical advantages of prosthetic endplate fixation properties.

Methods

Eight cervical implant configurations were evaluated in the current investigation: 1) PCM Low Profile; 2) PCM V-Teeth; 3) PCM Modular Flange; 4) PCM Fixed Flange; 5) Prestige LP; 6) Kineflex/C disc; 7) anterior cervical plate + interbody cage; and 8) tricortical iliac crest. All PCM treatments contained a serrated implant surface (0.4 mm). The PCM V-Teeth and Prestige contained 2 additional rows of teeth, which were 1 mm and 2 mm high, respectively. The PCM Modular and Fixed Flanged devices and anterior cervical plate were augmented with 4 vertebral screws. Eight pullout tests were performed for each of the 8 conditions by using a synthetic fixation model consisting of solid rigid polyurethane foam blocks. Biomechanical testing was conducted using an 858 Bionix test system configured with an unconstrained testing platform. Implants were positioned between testing blocks, using a compressive preload of −267 N. Tensile load-to-failure testing was performed at 2.5 mm/second, with quantification of peak load at failure (in Newtons), implant surface area (in square millimeters), and failure mechanisms.

Results

The mean loads at failure for the 8 implants were as follows: 257.4 ± 28.54 for the PCM Low Profile; 308.8 ± 15.31 for PCM V-Teeth; 496.36 ± 40.01 for PCM Modular Flange; 528.03± 127.8 for PCM Fixed Flange; 306.4 ± 31.3 for Prestige LP; 286.9 ± 18.4 for Kineflex/C disc; 635.53 ± 112.62 for anterior cervical plate + interbody cage; and 161.61 ± 16.58 for tricortical iliac crest. The anterior plate exhibited the highest load at failure compared with all other treatments (p < 0.05). The PCM Modular and Fixed Flange PCM constructs in which screw fixation was used exhibited higher pullout loads than all other treatments except the anterior plate (p < 0.05). The PCM VTeeth and Prestige and Kineflex/C implants exhibited higher pullout loads than the PCM Low Profile and tricortical iliac crest (p < 0.05). Tricortical iliac crest exhibited the lowest pullout strength, which was different from all other treatments (p < 0.05). The surface area of endplate contact, measuring 300 mm2 (PCM treatments), 275 mm2 (Prestige LP), 250 mm2 (Kineflex/C disc), 180 mm2 (plate + cage), and 235 mm2 (tricortical iliac crest), did not correlate with pullout strength (p > 0.05). The PCM, Prestige, and Kineflex constructs, which did not use screw fixation, all failed by direct pullout. Screw fixation devices, including anterior plates, led to test block fracture, and tricortical iliac crest failed by direct pullout.

Conclusions

These results demonstrate a continuum of fixation strength based on prosthetic endplate design. Disc arthroplasty constructs implanted using vertebral body screw fixation exhibited the highest pullout strength. Prosthetic endplates containing toothed ridges (≥ 1 mm) or keels placed second in fixation strength, whereas endplates containing serrated edges exhibited the lowest fixation strength. All treatments exhibited greater fixation strength than conventional tricortical iliac crest. The current study offers insights into the benefits of various prosthetic endplate designs, which may potentially improve acute fixation following cervical disc arthroplasty.

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Bryan W. Cunningham, Nadim J. Hallab, Nianbin Hu and Paul C. McAfee

Object

The introduction and utilization of motion-preserving implant systems for spinal reconstruction served as the impetus for this basic scientific investigation. The effect of unintended wear particulate debris resulting from micromotion at spinal implant interconnections and bearing surfaces remains a clinical concern. Using an in vivo rabbit model, the current study quantified the neural and systemic histopathological responses following epidural application of 11 different types of medical-grade particulate wear debris produced from spinal instrumentation.

Methods

A total of 120 New Zealand White rabbits were equally randomized into 12 groups based on implant treatment: 1) sham (control), 2) stainless steel, 3) titanium alloy, 4) cobalt chromium alloy, 5) ultra–high molecular weight polyethylene (UHMWPe), 6) ceramic, 7) polytetrafluoroethylene, 8) polycarbonate urethane, 9) silicone, 10) polyethylene terephthalate, 11) polyester, and 12) polyetheretherketone. The surgical procedure consisted of a midline posterior approach followed by resection of the L-6 spinous process and L5–6 ligamentum flavum, permitting interlaminar exposure of the dural sac. Four milligrams of the appropriate treatment material (Groups 2–12) was then implanted onto the dura in a dry, sterile format. All particles (average size range 0.1–50 μm in diameter) were verified to be endotoxin free prior to implantation. Five animals from each treatment group were sacrificed at 3 months and 5 were sacrificed at 6 months postoperatively. Postmortem analysis included epidural cultures and histopathological assessment of local and systemic tissue samples. Immunocytochemical analysis of the spinal cord and overlying epidural fibrosis quantified the extent of proinflammatory cytokines (tumor necrosis factor–α, tumor necrosis factor–β, interleukin [IL]–1α, IL-1β, and IL-6) and activated macrophages.

Results

Epidural cultures were negative for nearly all cases, and there was no evidence of particulate debris or significant histopathological changes in the systemic tissues. Gross histopathological examination demonstrated increased levels of epidural fibrosis in the experimental treatment groups compared with the control group. Histopathological evaluation of the epidural fibrous tissues showed evidence of a histiocytic reaction containing phagocytized inert particles and foci of local inflammatory reactions. At 3 months, immunohistochemical examination of the spinal cord and epidural tissues demonstrated upregulation of IL-6 in the groups in which metallic and UHMWPe debris were implanted (p < 0.05), while macrophage activity levels were greatest in the stainless-steel and UHMWPe groups (p < 0.05). By 6 months, the levels of activated cytokines and macrophages in nearly all experimental cases were downregulated and not significantly different from those of the operative controls (p > 0.05). The spinal cord had no evidence of lesions or neuropathology. However, multiple treatments in the metallic groups exhibited a mild, chronic macrophage response to particulate debris, which had diffused intrathecally.

Conclusions

Epidural application of spinal instrumentation particulate wear debris elicits a chronic histiocytic reaction localized primarily within the epidural fibrosis. Particles have the capacity to diffuse intrathecally, eliciting a transient upregulation in macrophage/cytokine activity response within the epidural fibrosis. Overall, based on the time periods evaluated, there was no evidence of an acute neural or systemic histopathological response to the materials included in the current project.

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Bryan W. Cunningham, Brent L. Atkinson, Nianbin Hu, Jun Kikkawa, Louis Jenis, Joseph Bryant, Paul O. Zamora and Paul C. McAfee

Object

New generations of devices for spinal interbody fusion are expected to arise from the combined use of bioactive peptides and porous implants. The purpose of this dose-ranging study was to evaluate the fusion characteristics of porous ceramic granules (CGs) coated with the bioactive peptide B2A2-K-NS (B2A) by using a model of instrumented lumbar interbody spinal fusion in sheep.

Methods

Instrumented spinal arthrodesis was performed in 40 operative sites in 20 adult sheep. In each animal, posterior instrumentation (pedicle screw and rod) and a polyetheretherketone cage were placed in 2 single-level procedures (L2–3 and L4–5). All cages were packed with graft material prior to implantation. The graft materials were prepared by mixing (1:1 vol/vol) CGs with or without a B2A coating and morselized autograft. Ceramic granules were coated with B2A at 50, 100, 300, and 600 μg/ml granules (50-B2A/CG, 100-B2A/CG, 300-B2A/CG, and 600-B2A/CG, respectively), resulting in 4 B2A-coated groups plus a control group (uncoated CGs). Graft material from each of these groups was implanted in 8 operative sites. Four months after arthrodesis, interbody fusion status was assessed with CT, and the interbody site was further evaluated with quantitative histomorphometry.

Results

All B2A/CG groups had higher CT-confirmed interbody fusion rates compared with those in controls (CGs only). Seven of 8 sites were fused in the 50-B2A/CG, 100-B2A/CG, and 300-B2A/CG groups, whereas 5 of 8 sites were fused in the group that had received uncoated CGs. New woven and lamellar bone spanned the fusion sites with excellent osseointegration. There was no heterotopic ossification or other untoward events attributed to the use of B2A/CG in any group. Each B2A/CG treatment produced more new bone than that in the CG group.

Conclusions

Bioactive treatment with B2A effectively enhanced the fusion capacity of porous CGs. These findings suggest that B2A/CG may well represent a new generation of biomaterials for lumbar interbody fusion and indicate that additional studies are warranted.

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Ryan M. Kretzer, Nianbin Hu, Hidemasa Umekoji, Daniel M. Sciubba, George I. Jallo, Paul C. McAfee, P. Justin Tortolani and Bryan W. Cunningham

Object

Thoracic pedicle screw instrumentation is often indicated in the treatment of trauma, deformity, degenerative disease, and oncological processes. Although classic teaching for cervical spine constructs is to bridge the cervicothoracic junction (CTJ) when instrumenting in the lower cervical region, the indications for extending thoracic constructs into the cervical spine remain unclear. The goal of this study was to determine the role of ligamentous and facet capsule (FC) structures at the CTJ as they relate to stability above thoracic pedicle screw constructs.

Methods

A 6-degree-of-freedom spine simulator was used to test multidirectional range of motion (ROM) in 8 human cadaveric specimens at the C7–T1 segment. Flexion-extension, lateral bending, and axial rotation at the CTJ were tested in the intact condition, followed by T1–6 pedicle screw fixation to create a long lever arm inferior to the C7–T1 level. Multidirectional flexibility testing of the T1–6 pedicle screw construct was then sequentially performed after sectioning the C7–T1 supraspinous ligament/interspinous ligament (SSL/ISL) complex, followed by unilateral and bilateral FC disruption at C7–T1. Finally, each specimen was reconstructed using C5–T6 instrumented fixation and ROM testing at the CTJ performed as previously described.

Results

Whereas the application of a long-segment thoracic construct stopping at T-1 did not significantly increase flexion-extension peak total ROM at the supra-adjacent level, sectioning the SSL/ISL significantly increased flexibility at C7–T1, producing 35% more motion than in the intact condition (p < 0.05). Subsequent FC sectioning had little additional effect on ROM in flexion-extension. Surprisingly, the application of thoracic instrumentation had a stabilizing effect on the supra-adjacent C7–T1 segment in axial rotation, leading to a decrease in peak total ROM to 83% of the intact condition (p < 0.05). This is presumably due to interaction between the T-1 screw heads and titanium rods with the C7–T1 facet joints, thereby limiting axial rotation. Incremental destabilization served only to restore peak total ROM near the intact condition for this loading mode. In lateral bending, the application of thoracic instrumentation stopping at T-1, as well as SSL/ISL and FC disruption, demonstrated trends toward increased supraadjacent ROM; however, these trends did not reach statistical significance (p > 0.05).

Conclusions

When stopping thoracic constructs at T-1, care should be taken to preserve the SSL/ISL complex to avoid destabilization of the supra-adjacent CTJ, which may manifest clinically as proximal-junction kyphosis. In an analogous fashion, if a T-1 laminectomy is required for neural decompression or surgical access, consideration should be given to extending instrumentation into the cervical spine. Facet capsule disruption, as might be encountered during T-1 pedicle screw placement, may not be an acutely destabilizing event, due to the interaction of the C7–T1 facet joints with T-1 instrumentation.