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Marco Túlio Reis, Eric W. Nottmeier, Phillip M. Reyes, Seungwon Baek and Neil R. Crawford

The Food and Drug Administration has not cleared the following medical devices for the use described in this study. The following medical devices are being discussed for an off-label use: cervical lateral mass screws.

Object

As an alternative for cases in which the anatomy and spatial relationship between C-2 and a vertebral artery precludes insertion of C-2 pedicle/pars or C1–2 transarticular screws, a technique that includes opposing laminar hooks (claw) at C-2 combined with C-1 lateral mass screws may be used. The biomechanical stability of this alternate technique was compared with that of a standard screw-rod technique in vitro.

Methods

Flexibility tests were performed in 7 specimens (occiput to C-3) in the following 6 different conditions: 1) intact; 2) after creating instability and attaching a posterior cable/graft at C1–2; 3) after removing the graft and attaching a construct comprising C-1 lateral mass screws and C-2 laminar claws; 4) after reattaching the posterior cable-graft at C1–2 (posterior hardware still in place); 5) after removing the posterior cable-graft and laminar hooks and placing C-2 pedicle screws interconnected to C-1 lateral mass screws via rod; and 6) after reattaching the posterior cable-graft at C1–2 (screw-rod construct still in place).

Results

All types of stabilization significantly reduced the range of motion, lax zone, and stiff zone compared with the intact condition. There was no significant biomechanical difference in terms of range of motion or lax zone between the screw-rod construct and the screw-claw-rod construct in any direction of loading.

Conclusions

The screw-claw-rod technique restricts motion much like the standard Harms technique, making it an acceptable alternative technique when aberrant arterial anatomy precludes the placement of C-2 pars/pedicle screws or C1–2 transarticular screws.

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Eric M. Horn, Phillip M. Reyes, Seungwon Baek, Mehmet Senoglu, Nicholas Theodore, Volker K. H. Sonntag and Neil R. Crawford

Object

The small diameter of the pedicle can make C-7 pedicle screw insertion dangerous. Although transfacet screws have been studied biomechanically when used in pinning joints, they have not been well studied when used as part of a C7–T1 screw/rod construct. The authors therefore compared C7–T1 fixation using a C-7 transfacet screw/T-1 pedicle screw construct with a construct composed of pedicle screws at both levels.

Methods

Each rigid posterior screw/rod construct was placed in 7 human cadaveric C6–T2 specimens (14 total). Specimens were tested in normal condition, after 2-column instability, and once fixated. Nondestructive, nonconstraining pure moments (maximum 1.5 Nm) were applied to induce flexion, extension, lateral bending, and axial rotation while recording 3D motion optoelectronically. The entire construct was then loaded to failure by dorsal linear force.

Results

There was no significant difference in angular range of motion between the 2 instrumented groups during any loading mode (p > 0.11, nonpaired t-tests). Both constructs reduced motion to < 2° in any direction and allowed significantly less motion than in the normal condition. The C-7 facet screw/T-1 pedicle screw construct allowed a small but significantly greater lax zone than the pedicle screw/rod construct during lateral bending, and it failed under significantly less load than the pedicle screw/rod construct (p < 0.001).

Conclusions

When C-7 transfacet screws are connected to T-1 pedicle screws, they provide equivalent stability of constructs formed by pedicle screws at both levels. Although less resistant to failure, the transfacet screw construct should be a viable alternative in patients with healthy bone.

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Andrew S. Little, Luis Perez-Orribo, Nestor G. Rodriguez-Martinez, Phillip M. Reyes, Anna G. U. S. Newcomb, Daniel M. Prevedello and Neil R. Crawford

Object

Endoscopic endonasal approaches to the craniovertebral junction (CVJ) and clivus are increasingly performed for ventral skull-base pathology, but the biomechanical implications of these approaches have not been studied. The aim of this study was to investigate the spinal biomechanics of the CVJ after an inferior-third clivectomy and anterior intradural exposure of the foramen magnum as would be performed in an endonasal endoscopic surgical strategy.

Methods

Seven upper-cervical human cadaveric specimens (occiput [Oc]–C2) underwent nondestructive biomechanical flexibility testing during flexion-extension, axial rotation, and lateral bending at Oc–C1 and C1–2. Each specimen was tested intact, after an inferior-third clivectomy, and after ligamentous complex dissection simulating a wide intradural exposure using an anterior approach. Angular range of motion (ROM), lax zone, and stiff zone were determined and compared with the intact state.

Results

Modest, but statistically significant, hypermobility was observed after inferior-third clivectomy and intradural exposure during flexion-extension and axial rotation at Oc–C1. Angular ROM increased incrementally between 6% and 12% in flexion-extension and axial rotation. These increases were primarily the result of changes in the lax zone. No significant changes were noted at C1–2.

Conclusions

Inferior-third clivectomy and an intradural exposure to the ventral CVJ and foramen magnum resulted in hypermobility at Oc–C1 during flexion-extension and axial rotation. Although the results were statistically significant, the modest degree of hypermobility observed compared with other well-characterized CVJ injuries suggests that occipitocervical stabilization may be unnecessary for most patients.

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Dean G. Karahalios, Taro Kaibara, Randall W. Porter, Udaya K. Kakarla, Phillip M. Reyes, Ali A. Baaj, Ali S. Yaqoobi and Neil R. Crawford

Object

An interspinous anchor (ISA) provides fixation to the lumbar spine to facilitate fusion. The biomechanical stability provided by the Aspen ISA was studied in applications utilizing an anterior lumbar interbody fusion (ALIF) construct.

Methods

Seven human cadaveric L3–S1 specimens were tested in the following states: 1) intact; 2) after placing an ISA at L4–5; 3) after ALIF with an ISA; 4) after ALIF with an ISA and anterior screw/plate fixation system; 5) after removing the ISA (ALIF with plate only); 6) after removing the plate (ALIF only); and 7) after applying bilateral pedicle screws and rods. Pure moments (7.5 Nm maximum) were applied in flexion and extension, lateral bending, and axial rotation while recording angular motion optoelectronically. Changes in angulation as well as foraminal height were also measured.

Results

All instrumentation variances except ALIF alone reduced angular range of motion (ROM) significantly from normal in all directions of loading. The ISA was most effective in limiting flexion and extension (25% of normal) and less effective in reducing lateral bending (71% of normal) and axial rotation (71% of normal). Overall, ALIF with an ISA provided stability that was statistically equivalent to ALIF with bilateral pedicle screws and rods. An ISA-augmented ALIF allowed less ROM than plate-augmented ALIF during flexion, extension, and lateral bending. Use of the ISA resulted in flexion at the index level, with a resultant increase in foraminal height. Compensatory extension at the adjacent levels prevented any significant change in overall sagittal balance.

Conclusions

When used with ALIF at L4–5, the ISA provides immediate rigid immobilization of the lumbar spine, allowing equivalent ROM to that of a pedicle screw/rod system, and smaller ROM than an anterior plate. When used with ALIF, the ISA may offer an alternative to anterior plate fixation or bilateral pedicle screw/rod constructs.

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Ali A. Baaj, Phillip M. Reyes, Ali S. Yaqoobi, Juan S. Uribe, Fernando L. Vale, Nicholas Theodore, Volker K. H. Sonntag and Neil R. Crawford

Object

Unstable fractures at the thoracolumbar junction often require extended, posterior, segmental pedicular fixation. Some surgeons have reported good clinical outcomes with short-segment constructs if additional pedicle screws are inserted at the fractured level. The goal of this study was to quantify the biomechanical advantage of the index-level screw in a fracture model.

Methods

Six human cadaveric T10–L4 specimens were tested. A 3-column injury at L-1 was simulated, and 4 posterior constructs were tested as follows: one-above-one-below (short construct) with/without index-level screws, and two-above-two-below (long construct) with/without index-level screws. Pure moments were applied quasistatically while 3D motion was measured optoelectronically. The range of motion (ROM) and lax zone across T12–L2 were measured during flexion, extension, left and right lateral bending, and left and right axial rotation.

Results

All constructs significantly reduced the ROM and lax zone in the fractured specimens. With or without index-level screws, the long-segment constructs provided better immobilization than the short-segment constructs during all loading modes. Adding an index-level screw to the short-segment construct significantly improved stability during flexion and lateral bending; there was no significant improvement in stability when an index-level screw was added to the long-segment construct. Overall, bilateral index-level screws decreased the ROM of the 1-level construct by 25% but decreased the ROM of the 2-level construct by only 3%.

Conclusions

In a fracture model, adding index-level pedicle screws to short-segment constructs improves stability, although stability remains less than that provided by long-segment constructs with or without index-level pedicle screws. Therefore, highly unstable fractures likely require extended, long-segment constructs for optimum stability.

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Bruno C. R. Lazaro, Fatih Ersay Deniz, Leonardo B. C. Brasiliense, Phillip M. Reyes, Anna G. U. Sawa, Nicholas Theodore, Volker K. H. Sonntag and Neil R. Crawford

Object

Posterior screw-rod fixation for thoracic spine trauma usually involves fusion across long segments. Biomechanical data on screw-based short-segment fixation for thoracic fusion are lacking. The authors compared the effects of spanning short and long segments in the thoracic spine.

Methods

Seven human spine segments (5 segments from T-2 to T-8; 2 segments from T-3 to T-9) were prepared. Pure-moment loading of 6 Nm was applied to induce flexion, extension, lateral bending, and axial rotation while 3D motion was measured optoelectronically. Normal specimens were tested, and then a wedge fracture was created on the middle vertebra after cutting the posterior ligaments. Five conditions of instrumentation were tested, as follows: Step A, 4-level fixation plus cross-link; Step B, 2-level fixation; Step C, 2-level fixation plus cross-link; Step D, 2-level fixation plus screws at fracture site (index); and Step E, 2-level fixation plus index screws plus cross-link.

Results

Long-segment fixation restricted 2-level range of motion (ROM) during extension and lateral bending significantly better than the most rigid short-segment construct. Adding index screws in short-segment constructs significantly reduced ROM during flexion, lateral bending, and axial rotation (p < 0.03). A cross-link reduced axial rotation ROM (p = 0.001), not affecting other loading directions (p > 0.4).

Conclusions

Thoracic short-segment fixation provides significantly less stability than long-segment fixation for the injury studied. Adding a cross-link to short fixation improved stability only during axial rotation. Adding a screw at the fracture site improved short-segment stability by an average of 25%.

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Nestor G. Rodriguez-Martinez, Sam Safavi-Abbasi, Luis Perez-Orribo, Anna G. U. S. Newcomb, Phillip M. Reyes, Galyna Loughran, Nicholas Theodore and Neil R. Crawford

OBJECT

The Universal Clamp Spinal Fixation System (UC) is a novel sublaminar connection for the spine that is currently used in conjunction with pedicle screws at the thoracic levels for the correction of scoliosis. This device allows the surgeon to attach rods and incorporate a pedicle screw construction. The flexible composition of the UC should provide flexibility intermediate to the uninstrumented spine and an all-screw construct. This hypothesis was tested in vitro using nondestructive flexibility testing of human cadaveric spine segments.

METHODS

Six unembalmed human cadaveric thoracic spine segments from T-3 to T-11 were used. The specimens were tested under the following conditions: 1) intact; 2) after bilateral screws were placed at T4-T10 and interconnected with longitudinal rods; 3) after placement of a hybrid construction with screws at T-4, T-7, and T-10 with an interconnecting rod on one side and screws at T-4 and T-10 with the UC at T5–9 on the contralateral side; (4) after bilateral screws were placed at T-4 and T-10 and interconnected with rods and bilateral UC were placed at T5–9; and 5) after bilateral screws at T-4 and T-10 were placed and interconnected with rods and bilateral sublaminar cables were placed at T5–9. Pure moments of 6.0 Nm were applied while optoelectronically recording 3D angular motion.

RESULTS

Bilateral UC placement and bilateral sublaminar cables both resulted in a significantly greater range of motion than bilateral pedicle screws during lateral bending and axial rotation, but not during flexion or extension. There were no differences in stability between bilateral UC and bilateral cables. The construct with limited screws on one side and UC contralaterally showed comparable stability to bilateral UC and bilateral cables.

CONCLUSIONS

These results support using the UC as a therapeutic option for spinal stabilization because it allows comparable stability to the sublaminar cables and provides flexibility intermediate to that of the uninstrumented spine and an all-screw construct. Equivalent stability of the hybrid, bilateral UC, and bilateral cable constructs indicates that 6-level UC provides stability comparable to that of a limited (3-point) pedicle screw-rod construct.

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Nestor G. Rodriguez-Martinez, Luis Perez-Orribo, Samuel Kalb, Phillip M. Reyes, Anna G. U. S. Newcomb, Jeremy Hughes, Nicholas Theodore and Neil R. Crawford

OBJECT

The effects of obesity on lumbar biomechanics are not fully understood. The aims of this study were to analyze the biomechanical differences between cadaveric L4–5 lumbar spine segments from a large group of nonobese (body mass index [BMI] < 30 kg/m2) and obese (BMI ≥ 30 kg/m2) donors and to determine if there were any radiological differences between spines from nonobese and obese donors using MR imaging.

METHODS

A total of 168 intact L4–5 spinal segments (87 males and 81 females) were tested using pure-moment loading, simulating flexion-extension, lateral bending, and axial rotation. Axial compression tests were performed on 38 of the specimens. Sex, age, and BMI were analyzed with biomechanical parameters using 1-way ANOVA, Pearson correlation, and multiple regression analyses. MR images were obtained in 12 specimens (8 from obese and 4 from nonobese donors) using a 3-T MR scanner.

RESULTS

The segments from the obese male group allowed significantly greater range of motion (ROM) than those from the nonobese male group during axial rotation (p = 0.018), while there was no difference between segments from obese and nonobese females (p = 0.687). There were no differences in ROM between spines from obese and nonobese donors during flexion-extension or lateral bending for either sex. In the nonobese population, the ROM during axial rotation was significantly greater for females than for males (p = 0.009). There was no significant difference between sexes in the obese population (p = 0.892). Axial compressive stiffness was significantly greater for the obese than the nonobese population for both the female-only group and the entire study group (p < 0.01); however, the difference was nonsignificant in the male population (p = 0.304). Correlation analysis confirmed a significant negative correlation between BMI and resistance to deformation during axial compression in the female group (R = −0.65, p = 0.004), with no relationship in the male group (R = 0.03, p = 0.9). There was also a significant negative correlation between ROM during flexion-extension and BMI for the female group (R = −0.38, p = 0.001), with no relationship for the male group (R = 0.06, p = 0.58). Qualitative analysis using MR imaging indicated greater facet degeneration and a greater incidence of disc herniations in the obese group than in the control group.

CONCLUSIONS

Based on flexibility and compression tests, lumbar spinal segments from obese versus nonobese donors seem to behave differently, biomechanically, during axial rotation and compression. The differences are more pronounced in women. MR imaging suggests that these differences may be due to greater facet degeneration and an increased amount of disc herniation in the spines from obese individuals.

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Marco T. Reis, Phillip M. Reyes, BSE, Idris Altun, Anna G. U. S. Newcomb, Vaneet Singh, Steve W. Chang, Brian P. Kelly and Neil R. Crawford

OBJECTIVE

Lateral lumbar interbody fusion (LLIF) has emerged as a popular method for lumbar fusion. In this study the authors aimed to quantify the biomechanical stability of an interbody implant inserted using the LLIF approach with and without various supplemental fixation methods, including an interspinous plate (IP).

METHODS

Seven human cadaveric L2–5 specimens were tested intact and in 6 instrumented conditions. The interbody implant was intended to be used with supplemental fixation. In this study, however, the interbody was also tested without supplemental fixation for a relative comparison of these conditions. The instrumented conditions were as follows: 1) interbody implant without supplemental fixation (LLIF construct); and interbody implant with supplemental fixation performed using 2) unilateral pedicle screws (UPS) and rod (LLIF + UPS construct); 3) bilateral pedicle screws (BPS) and rods (LLIF + BPS construct); 4) lateral screws and lateral plate (LP) (LLIF + LP construct); 5) interbody LP and IP (LLIF + LP + IP construct); and 6) IP (LLIF + IP construct). Nondestructive, nonconstraining torque (7.5 Nm maximum) induced flexion, extension, lateral bending, and axial rotation, whereas 3D specimen range of motion (ROM) was determined optoelectronically.

RESULTS

The LLIF construct reduced ROM by 67% in flexion, 52% in extension, 51% in lateral bending, and 44% in axial rotation relative to intact specimens (p < 0.001). Adding BPS to the LLIF construct caused ROM to decrease by 91% in flexion, 82% in extension and lateral bending, and 74% in axial rotation compared with intact specimens (p < 0.001), providing the greatest stability among the constructs. Adding UPS to the LLIF construct imparted approximately one-half the stability provided by LLIF + BPS constructs, demonstrating significantly smaller ROM than the LLIF construct in all directions (flexion, p = 0.037; extension, p < 0.001; lateral bending, p = 0.012) except axial rotation (p = 0.07). Compared with the LLIF construct, the LLIF + LP had a significant reduction in lateral bending (p = 0.012), a moderate reduction in axial rotation (p = 0.18), and almost no benefit to stability in flexion-extension (p = 0.86). The LLIF + LP + IP construct provided stability comparable to that of the LLIF + BPS. The LLIF + IP construct provided a significant decrease in ROM compared with that of the LLIF construct alone in flexion and extension (p = 0.002), but not in lateral bending (p = 0.80) and axial rotation (p = 0.24). No significant difference was seen in flexion, extension, or axial rotation between LLIF + BPS and LLIF + IP constructs.

CONCLUSIONS

The LLIF construct that was tested significantly decreased ROM in all directions of loading, which indicated a measure of inherent stability. The LP significantly improved the stability of the LLIF construct in lateral bending only. Adding an IP device to the LLIF construct significantly improves stability in sagittal plane rotation. The LLIF + LP + IP construct demonstrated stability comparable to that of the gold standard 360° fixation (LLIF + BPS).

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Fatih Ersay Deniz, Leonardo B. C. Brasiliense, Bruno C. R. Lazaro, Phillip M. Reyes, Anna G. U. Sawa, Volker K. H. Sonntag and Neil R. Crawford

Object

The authors investigated the biomechanical properties of transpedicular discectomy in the thoracic spine and compared the effects on spinal stability of a partial and total facetectomy.

Methods

Human thoracic specimens were tested while intact, after a transpedicular discectomy with partial facetectomy, and after an additional total facetectomy was incorporated. Nonconstraining pure moments were applied under load control (maximum 7.5 Nm) to induce flexion, extension, lateral bending, and axial rotation while spinal motion was measured at T8–9 optoelectronically. The range of motion (ROM) and lax zone were determined in each specimen and compared among conditions.

Results

Transpedicular discectomy with and without a total facetectomy significantly increased the ROM and lax zone in all directions of loading compared with the intact spine (p < 0.008). The segmental increase in ROM observed with the transpedicular discectomy was 25%. The additional total facetectomy created an insignificant 3% further increase in ROM compared with medial facetectomy (p > 0.2).

Conclusions

Transpedicular discectomy can be performed in the thoracic spine with a modest decrease in stability expected. Because the biomechanical behavior of a total facetectomy is equivalent to that of a medial facetectomy, the additional facet removal may be incorporated without further biomechanical consequences.