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Masahiro Kanayama, Bryan W. Cunningham, Charles J. Haggerty, Kuniyoshi Abumi, Kiyoshi Kaneda and Paul C. McAfee

Object. Interbody fusion devices are rapidly gaining acceptance as a method of ensuring lumbar interbody arthrodesis. Although different types of devices have been developed, the comparative reconstruction stability remains controversial. It also remains unclear how different stress-shielded environments are created within the devices. Using a calf spine model, this study was designed to compare the construct stiffness afforded by 11 differently designed lumbar interbody fusion devices and to quantify their stress-shielding effects by measuring pressure within the devices.

Methods. Sixty-six lumbar specimens obtained from calves were subjected to anterior interbody reconstruction at L4–5 by using one of the following interbody fusion devices: four different threaded fusion cages (BAK device, BAK Proximity, Ray TFC, and Danek TIBFD), five different nonthreaded fusion devices (oval and circular Harms cages, Brantigan PLIF and ALIF cages, and InFix device); two different types of allograft (femoral ring and bone dowel) were used. Construct stiffness was evaluated in axial compression, torsion, flexion, and lateral bending. Prior to testing, a silicon elastomer was injected into the cages and intracage pressures were measured using pressure needle transducers.

Conclusions. No statistical differences were observed in construct stiffness among the threaded cages and nonthreaded devices in most of the testing modalities. Threaded fusion cages demonstrated significantly lower intracage pressures compared with nonthreaded cages and structural allografts. Compared with nonthreaded cages and structural allografts, threaded fusion cages afforded equivalent reconstruction stiffness but provided more stress-shielded environment within the devices.

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Yoshihisa Kotani, Bryan W. Cunningham, Kuniyoshi Abumi, Anton E. Dmitriev, Manabu Ito, Niabin Hu, Yasuo Shikinami, Paul C. McAfee and Akio Minami

Object. This in vitro experimental study was conducted to investigate the initial biomechanical effect of artificial intervertebral disc replacement in the cervical spine. The multidirectional flexibility of replaced and adjacent spinal segments were analyzed using a cadaveric cervical spine model.

Methods. The following three cervical reconstructions were sequentially performed at the C5–6 level after anterior discectomy in seven human cadaveric occipitocervical spines: anterior artificial disc replacement with a bioactive three-dimensional (3D) fabric disc (FD); anterior iliac bone graft; and anterior plate fixation with iliac bone graft. Six unconstrained pure moments were applied with a 6-df spine simulator, and 3D segmental motions at the operative and adjacent segments were measured with an optoelectronic motion measurement system. The 3D FD group demonstrated statistically equivalent ranges of motion (ROMs) when compared with intact values in axial rotation and lateral bending. The 45% increase in flexion—extension ROM was demonstrated in 3D FD group; however, neutral zone analysis did not reach statistical significance between the intact spine and 3D FD. The anterior iliac bone graft and iliac bone graft reconstructions demonstrated statistically lower ROMs when compared with 3D FD in all loading modes (p < 0.05). The adjacent-level ROMs of the 3D FD group demonstrated nearly physiological characteristics at upper and lower adjacent levels. Excellent stability at the interface was maintained during the whole testing without any device displacement and dislodgment.

Conclusions. The stand-alone cervical 3D FD demonstrated nearly physiological biomechanical characteristics at both operative and adjacent spinal segments in vitro, indicating an excellent clinical potential for cervical artificial disc replacement.

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Yasuhiro Tominaga, Travis G. Maak, Paul C. Ivancic, Manohar M. Panjabi and Bryan W. Cunningham

Object

A rotated head posture at the time of vehicular rear impact has been correlated with a higher incidence and greater severity of chronic radicular symptoms than accidents occurring with the occupant facing forward. No studies have been conducted to quantify the dynamic changes in foramen dimensions during head-turned rear-impact collisions. The objectives of this study were to quantify the changes in foraminal width, height, and area during head-turned rear-impact collisions and to determine if dynamic narrowing causes potential cervical nerve root or ganglion impingement.

Methods

The authors subjected a whole cervical spine model with muscle force replication and a surrogate head to simulated head-turned rear impacts of 3.5, 5, 6.5, and 8 G following a noninjurious 2-G baseline acceleration. Continuous dynamic foraminal width, height, and area narrowing were recorded, and peaks were determined during each impact; these data were then statistically compared with those obtained at baseline.

The authors observed significant increases (p < 0.05) in mean peak foraminal width narrowing values greater than baseline values, of up to 1.8 mm in the left C5–6 foramen at 8 G. At the right C2–3 foramen, the mean peak dynamic foraminal height was significantly narrower than baseline when subjected to rear-impacts of 5 and 6.5 G, but no significant increases in foraminal area were observed. Analysis of the results indicated that the greatest potential for cervical ganglion compression injury existed at C5–6 and C6–7. Greater potential for ganglion compression injury existed at C3–4 and C4–5 during head-turned rear impact than during head-forward rear impact.

Conclusions

Extrapolation of present results indicated potential ganglion compression in patients with a non-stenotic foramen at C5–6 and C6–7; in patients with a stenotic foramen the injury risk greatly increases and spreads to include the C3–4 through C6–7 as well as C4–5 through C6–7 nerve roots.

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Bryan W. Cunningham, Paul C. McAfee, Fred H. Geisler, Gwen Holsapple, Karen Adams, Scott L. Blumenthal, Richard D. Guyer, Andrew Cappuccino, John J. Regan, Ira L. Fedder and P. Justin Tortolani

Object

One of the goals of lumbar arthroplasty is to restore and maintain range of motion (ROM) and to protect adjacent levels from abnormal motion, which may be a factor in transition syndrome following arthrodesis. In this study, in vitro ROM results were compared with in vivo, 2-year postoperative radiographic ROM evaluations.

Methods

Radiographs of patients enrolled in the CHARITÉ investigational device exemption study were analyzed at baseline and at 2 years postoperatively. The ROM in flexion/extension at the implanted and adjacent levels was measured, normalized, and compared with ROM results obtained using cadaver (in vitro) evaluations.

Results

Preoperative ROM distributions in patients enrolled for arthroplasty or fusion at the L4–5 level was as follows: 28% motion was observed at L3–4, 35% at L4–5 and 37% at L5–S1. Following a one-level arthroplasty at L4–5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 36% at L3–4, 30% at L4–5 and 35% at L5–S1. Following a one-level fusion with BAK and pedicle screws at L4–5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 45% at L3–4, 9% at L4–5 and 46% at L5–S1.

Conclusions

The baseline as well as the 2-year in vivo data confirmed previously published in vitro data. One-level arthroplasty was shown herein to replicate the normal distribution of motion of the intact spine.

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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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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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Ryan M. Kretzer, Christopher Chaput, Daniel M. Sciubba, Ira M. Garonzik, George I. Jallo, Paul C. McAfee, Bryan W. Cunningham and P. Justin Tortolani

Object

Translaminar screws (TLSs) offer an alternative to pedicle screw (PS) fixation in the upper thoracic spine. Although cadaveric studies have described the anatomy of the laminae and pedicles at T1–2, CT imaging is the modality of choice for presurgical planning. In this study, the goal was to determine the diameter, maximal screw length, and optimal screw trajectory for TLS placement at T1–2, and to compare this information to PS placement in the upper thoracic spine as determined by CT evaluation.

Methods

One hundred patients (50 men and 50 women), whose average age was 41.7 ± 19.6 years, were selected by retrospective review of a trauma registry database over a 6-month period. Patients were included in the study if they were over the age of 18, had standardized axial bone-window CT imaging at T1–2, and had no evidence of spinal trauma. For each lamina and pedicle, width (outer cortical and cancellous), maximal screw length, and optimal screw trajectory were measured using eFilm Lite software. Statistical analysis was performed using the Student t-test.

Results

The T-1 lamina was estimated to accommodate, on average, a 5.8-mm longer screw than the T-2 lamina (p < 0.001). At T-1, the maximal TLS length was similar to PS length (TLS: 33.4 ± 3.6 mm, PS: 33.9 ± 3.3 mm [p = 0.148]), whereas at T-2, the maximal PS length was significantly greater than the TLS length (TLS: 27.6 ± 3.1 mm, PS: 35.3 ± 3.5 mm [p < 0.001]). When the lamina outer cortical and cancellous width was compared between T-1 and T-2, the lamina at T-2 was, on average, 0.3 mm wider than at T-1 (p = 0.007 and p = 0.003, respectively). In comparison with the corresponding pedicle, the mean outer cortical pedicle width at T-1 was wider than the lamina by an average of 1.0 mm (lamina: 6.6 ± 1.1 mm, pedicle: 7.6 ± 1.3 mm [p < 0.001]). At T-2, however, outer cortical lamina width was wider than the corresponding pedicle by an average of 0.6 mm (lamina: 6.9 ± 1.1 mm, pedicle: 6.3 ± 1.2 mm [p < 0.001]). At T-1, 97.5% of laminae measured could accept a 4.0-mm screw with 1.0 mm of clearance, compared with 99.5% of T-1 pedicles; whereas at T-2, 99% of laminae met this requirement, compared with 94.5% of pedicles. The ideal screw trajectory was also measured (T-1: 49.2 ± 3.7° for TLS and 32.8 ± 3.8° for PS; T-2: 51.1 ± 3.5° for TLS and 20.5 ± 4.4° for PS).

Conclusions

Based on CT evaluation, there are no anatomical limitations to the placement of TLSs compared with PSs at T1–2. Differences were noted, however, in lamina length and width between T-1 and T-2 that must be considered when placing TLS at these levels.

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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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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.

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Ryan M. Kretzer, Christopher Chaput, Daniel M. Sciubba, Ira M. Garonzik, George I. Jallo, Paul C. McAfee, Bryan W. Cunningham and P. Justin Tortolani

Object

The objective of this study was to establish normative data for thoracic pedicle anatomy in the US adult population. To this end, CT scans chosen at random from an adult database were evaluated to determine the ideal pedicle screw (PS) length, diameter, trajectory, and starting point in the thoracic spine. The role of patient sex and side of screw placement were also assessed. The authors postulated that this information would be of value in guiding safe implant size and placement for surgeons in training.

Methods

One hundred patients (50 males and 50 females) were selected via retrospective review of a hospital trauma registry database over a 6-month period. Patients included in the study were older than 18 years of age, had axial bone-window CT images of the thoracic spine, and had no evidence of spinal trauma. For each pedicle, the pedicle width, pedicle-rib width, estimated screw length, trajectory, and ideal entry point were measured using eFilm Lite software. Statistical analysis was performed using the Student t-test.

Results

The shortest mean estimated PS length was at T-1 (33.9 ± 3.3 mm), and the longest was at T-9 (44.9 ± 4.4 mm). Pedicle screw length was significantly affected by patient sex; men could accommodate a PS from T1–12 a mean of 4.0 ± 1.0 mm longer than in women (p < 0.001). Pedicle width showed marked variation by spinal level, with T-4 (4.4 ± 1.1 mm) having the narrowest width and T-12 (8.3 ± 1.7 mm) having the widest. Pedicle width had an obvious affect on potential screw diameter; 65% of patients had a least 1 pedicle at T-4 that was < 5 mm in diameter and therefore would not accept a 4.0-mm screw with 1.0 mm of clearance, as compared with only 2% of patients with a similar status at T-12. Sex variation was also apparent, as thoracic pedicles from T-1 to T-12 were a mean of 1.4 ± 0.2 mm wider in men than in women (p < 0.001). The PS trajectory in the axial plane was measured, showing a marked decrease from T-1 to T-4, stabilization from T-5 to T-10, followed by a decrease at T11–12. When screw trajectory was stratified by side of placement, a mean of 1.7° ± 0.5° of increased medialization was required for ideal pedicle cannulation from T-3 to T-12 on the left as compared with the right side, presumably because of developmental changes in the vertebral body caused by the aorta (p < 0.05 for T3–12, except for T-5, where p = 0.051). The junction of the superior articular process, lamina, and the superior ridge of the transverse process was shown to be a conserved surface landmark for PS placement.

Conclusions

Preoperative CT evaluation is important in choosing PS length, diameter, trajectory, and entry point due to variation based on spinal level, patient sex, and side of placement. These data are valuable for resident and fellow training to guide the safe use of thoracic PSs.