P113. Clinical and Radiological Outcomes of Stand-alone Anterior Lumbar Interbody Fusion: Two Year...
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Transcript of P113. Clinical and Radiological Outcomes of Stand-alone Anterior Lumbar Interbody Fusion: Two Year...
155SProceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S
METHODS: Bilateral SEPs were elicited by posterior tibial nerve stimu-
lation while tcMEPs were elicited by standard scalp stimulation. ‘‘Signif-
icant’’ EP changes prompted evaluation for possible technical causes and
neurolgical injury. In reliably-monitored patients who had no technical
monitoring problems, significant EP changes were deemed true positives
and prompted rapid intervention (e.g. wake up tests, corticosteroids and/
or hardware modification).
RESULTS: 151 of 162 (93%) patients had EP signals considered adequate
for reliable monitoring. In patients with unreliable monitoring, 4 of 11 had
neuromuscular scoliosis. Of the 151 reliably monitored patients, 12 (7.9%)
had changes in either SEPs or tcMEPs. In four patients, changes were
noted in tcMEP but not SEP monitoring. The determined causes of EP
changes included curve correction (n58), hypotension (n52), direct cord
trauma (n51), and pedicle screw malposition (n51). Appropriate and im-
mediate intervention resulted in the return of normal EP signals in 10 pa-
tients. One patient had a persistent but improved abnormal neurologic
examination at last follow up. Patients with cardiopulmonary disease had
a significantly higher rate of EP events compared to patients with no such
comorbidities (p50.011).
CONCLUSIONS: Combined SEP/tcMEP monitoring is an effective
method for preventing neurologic injury in patients undergoing all types
of pediatric spinal deformity surgery. Despite the potential for false posi-
tive results, we recommend setting a low threshold to define significant in-
traoperative EP changes. Rapid intervention can reverse changes in EPs
and avoid potentially significant neurological complications. Patients with
cardiopulmonary comorbidities may be at higher risk of significant EP
events, and should be approached with caution and careful electrophysio-
logic monitoring.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi:10.1016/j.spinee.2008.06.357
P112. PEMF Increases ACDF Fusion Rates in Patients 50 or Older
Kevin Foley, MD; University of Tennessee, Memphis, TN, USA
BACKGROUND CONTEXT: Although multiple factors have been re-
ported to influence fusion rates following ACDF surgery, patient age
greater than 50 has been found to have the only statistically significant cor-
relation with delayed union.
PURPOSE: To determine the influence of pulsed electromagnetic field
stimulation (PEMF) on ACDF after age 50.
STUDY DESIGN/ SETTING: Randomized, prospective, controlled, mul-
ticenter clinical trial.
PATIENT SAMPLE: The data for this study were obtained from a clinical
trial examining the effects of PEMF on cervical fusion (1). Patients with
symptomatic radiculopathy and correlating radiographic evidence of cervi-
cal nerve root compression were candidates for entry into the study. All
patients were either smokers (at least 1 pack/day) or required multi-level
surgery and underwent anterior cervical discectomy and Smith-Robinson
fusion using allograft bone and anterior cervical plating (single plating
system).
OUTCOME MEASURES: Radiographs were read blindly by two inde-
pendent orthopedic spine surgeons, as well as an independent radiologist,
and rated as ‘‘fused’’ or ‘‘not fused’’ based upon radiolucency, bony bridg-
ing, and motion on flexion-extension views. The motion assessment was
performed using a customized software package (QMA�, Medical Met-
rics, Inc.) that produced a digitized overlay of the flexion and extension
views.
METHODS: Patients were randomized to receive post-operative pulsed
electromagnetic field stimulation (PEMF) or not (non-PEMF). All patients
wore a soft cervical collar for one week post-operatively. Those random-
ized to the PEMF stimulation group started within 7 days post-operatively
and wore the Cervical-Stim device (Orthofix, Inc.) for 4 hours per day for 3
months. Follow-up visits occurred at 1, 2, 3, 6, and 12-month intervals.
Compliance was assessed at each post-operative visit via a print-out of
PEMF ‘‘on’’ time, which was automatically monitored by the Cervical-
Stim device. Radiographic examinations, including anteroposterior, lateral,
and flexion/extension lateral images were performed at 3, 6 and 12 months
post-operatively.
RESULTS: Fusion results in the control (non-PEMF) group were stratified
by various risk factors. Age was the only factor significantly related to fu-
sion rate. By six months post-op, patients younger than 50 had an overall
fusion rate of 74.4%, whereas only 55.6% of patients 50 or older were clas-
sified as fused by this time point. At one year, 91.6% of patients younger
than 50 were rated as fused, whereas only 75.7% of patients 50 years of
age or older had osseous unions (p50.0180). The control group was then
compared with the PEMF group to determine the influence of PEMF on the
fusion rates in the patient population stratified by age. The use of postop-
erative PEMF resulted in a fusion rate of 85.3% in patients younger than
50 at 6 months and 92.1% at one year post-op (not significant compared
to the control patients of the same age, p50.0891 and p50.9014, respec-
tively). In contrast, for patients 50 years of age or older, the use of post-
operative PEMF resulted in a fusion rate of 80.9% at 6 months
(p50.0128, compared to control patients in the same age group) and
93.9% at one year (p50.0159, compared to controls).
CONCLUSIONS: There was a statistically significant improvement in the
fusion rates at 6 months and one year postoperatively for patients 50 years
of age or older who were treated with postoperative PEMF following
ACDF with allograft and a cervical plate.
FDA DEVICE/DRUG STATUS: Cervical-Stim: Approved for this
indication.
doi:10.1016/j.spinee.2008.06.358
P113. Clinical and Radiological Outcomes of Stand-alone Anterior
Lumbar Interbody Fusion: Two Year Results
Christopher Cain, MBBS, FRACS, MD1, David Ardern, MBBS, FRACS1,
Martin Wilby1, Simon Tizzard2, Bernard LaRue2, Russell Morcom3,
David Hall, MD2; 1Adelaide, South Australia, Australia; 2Royal Adelaide
Hospital, Adelaide, South Australia, Australia; 3Dr Jones & Partners,
Radiologists, Adelaide, South Australia, Australia
BACKGROUND CONTEXT: Anterior lumbar interbody fusion (ALIF)
is an accepted surgical treatment for disabling discogenic pain. Additional
posterior fixation has been advocated; however this is associated with sig-
nificant surgical morbidity. This is a prospective clinical study evaluating
a stand-alone anterior fusion cage with an integrated titanium plate and
four divergent locking screws.
PURPOSE: To evaluate the clinical and radiographic outcome of a new
stand alone anterior lumbar fusion device in the management of discogenic
low back pain.
STUDY DESIGN/ SETTING: Prospective clinical and radiographic eval-
uation of patients undergoing surgical treatment of discogenic low back
pain utilizing a standalone anterior fusion cage was undertaken since
Nov 1st 2005.
PATIENT SAMPLE: Patients with one or two level symptomatic lumbar
disc degeneration identified by lumbar discography and who had failed ap-
propriate non-operative management for at least six months were consid-
ered for surgical treatment and recruited into the study.
OUTCOME MEASURES: Visual Analogue Pain Scores (VAS), Oswes-
try Disability Index (ODI) and SF-36 data was collected pre-operatively, at
3, 6, 12 and 24 months post surgery. Plain radiographs were undertaken at
similar intervals and fine-cut helical CT with reconstructions was
performed at one and two years post-operatively.
METHODS: Surgery was performed through an anterior retro-peritoneal
approach. The fusion cage was packed with autogenous bone graft. Fusion
was defined as continuous bony trabeculae joining the vertebral bodies.
Compensation, smoking and other demographic factors were also evalu-
ated in relation to the clinical outcome.
156S Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S
RESULTS: Fifty-five levels were operated on in 43 patients with a mean
age of 40 years (22-57). Thirty-nine patients have completed one-year fol-
low-up and 19 have completed two-year follow-up. The mean operative
time was less than 120 minutes, and mean blood loss less than 200 ml.
Radiographic fusion at one year was 78% and 100% at two years. Two
year mean VAS scores for back pain improved from 7 to 3.5 (p!0.01)
and for leg pain from 6.3 to 2.8 (p!0.01). The mean ODI scores decreased
from 48 to 33 (p!0.01), and SF-36 physical function scores increased from
30 to 37 (p!0.01). Compensation was identified as a significant negative
factor in relation to clinical outcome. There were no major complications
and no patients have required supplementary posterior fixation.
CONCLUSIONS: This technique has been shown to be safe and is as ef-
fective as 360o fusion in achieving fusion in the management of discogenic
back pain over one and two levels. It also has the additional advantage of
avoiding the morbidity associated with additional posterior fixation.
FDA DEVICE/DRUG STATUS: SynFix-Synthes: Approved for this
indication.
doi:10.1016/j.spinee.2008.06.359
P114. Biomechanics of Multilevel Cervical Arthroplasty and
Combined Arthrodesis and Arthroplasty
Neil Crawford, PhD, Sam Safavi-Abbasi, MD, PhD, Seungwon Baek, MS,
Phillip Reyes, BS, Mehmet Senoglu, MD, Volker Sonntag, MD; Barrow
Neurological Institute, Phoenix, AZ, USA
BACKGROUND CONTEXT: Little research exists on the biomechanics
of combined cervical arthroplasty/arthrodesis and multilevel arthroplasty
instrumentation. Simply studying the range of motion of these conditions
in vitro provides little useful information.
PURPOSE: To investigate how arthrodesis/arthroplasty affect posture and
distribution of segmental angles under physiologic loads.
STUDY DESIGN/ SETTING: 3D motion of individual motion segments
was monitored during in vitro loading after different combinations of mul-
tilevel arthroplasty and arthrodesis.
PATIENT SAMPLE: 7 human cadaveric C3-T1 specimens (32-67 years).
OUTCOME MEASURES: Segmental compensation to restore the origi-
nal neutral postural balance, tendency for buckling while maintaining
global neutral postural balance, and shift in sagittal plane axis of rotation.
METHODS: After completing normal tests, C4-5, C5-6 and C6-7
received arthroplasty using ProDisc-C (Synthes Spine, Paoli, PA). Then,
using a rigid screw-rod system with 3 points of fixation per vertebra,
various combinations of fusion (‘‘f’’) adjacent to arthroplasty (‘‘A’’) were
simulated at C4-C5, C5-6 and C6-7 respectively: fAA, AfA, AAf, ffA, fAf,
Aff, fff. C3-4 and C7-T1 were left intact during all tests. A compressive
belt apparatus was used to simulate normal muscle co-contraction and
gravitational preload. This apparatus controlled the angle of C3 relative
to T1 but did not interface with intermediate levels. All motion segments
(C3-4, C4-5, C5-6, C6-7 and C7-T1) were individually monitored using
3D optical tracking.
RESULTS: During all 7 conditions in which one or more levels were
mobile, the arthroplasty levels preferentially moved toward upright
posture more easily than the normal intact levels. This difference was
significant in the AAA, fAA, fAf, ffA configurations (p!0.05, paired
Student’s t-tests). To keep a global, upright posture of 0 �, the buckling
(sum of unsigned segmental angles) was greatest for 3-level arthroplasty,
less for 2-level arthroplasty, and least for 1-level arthroplasty (Figure).
Among the three 1-level arthroplasty groups (ffA, fAf, Aff), arthroplasty
at the caudalmost level resulted in significantly greater buckling than
when arthroplasty was in the rostralmost or middle segment (p!0.04,
ANOVA/Holm-Sidak). The IAR location was related to buckling such
that anterior IAR shift resulted in extension and posterior IAR shift re-
sulted in flexion. Although worse buckling tended to occur with greater
shifts in the axis of rotation, this correlation did not reach significance
(p50.112).
CONCLUSIONS: Arthroplasty levels provide the ‘‘path of least resis-
tance,’’ through which initial motion is more likely than normal levels,
possibly related to focal kyphosis seen clinically with cervical arthroplasty.
The tendency for buckling under compression became greater with more
arthroplasty levels. Buckling appeared more severe with arthroplasty more
caudal. Buckling only moderately correlated to IARshifts, implying that
slight device malpositioning should not predispose the patient to buckling.
Figure. Buckling under 70N compression, measured as the sum of un-
signed segmental angles after restoring zero degrees global posture
(sum of signed segmental angles). From C3-C4 to C6-C7, A=arthro-
plasty level, f=fusion level. Error bars show std. dev.
FDA DEVICE/DRUG STATUS: ProDisc-C: Approved for this indica-
tion; CSLP: Approved for this indication.
doi:10.1016/j.spinee.2008.06.360
P115. Low Profile Pelvic Fixation Anatomic Parameters for Sacral
Alariliac Fixation vs. Traditional Iliac Fixation
Tai-Li Chang, Paul Sponseller, MD, Khaled Kebaish, MD, Elliot Fishman,
MD; Johns Hopkins University, Baltimore, MD, USA
BACKGROUND CONTEXT: Compared to traditional iliac fixation of
insertion through the posterior superior iliac spine (PSIS), insertion of iliac
anchors through the S2 ala may provide nearly equal length with a starting
point that is more in-line and 1.9cm deeper. Three-dimensional radio-
graphic analysis describes an ideal pathway of approximately 40 � of cau-
dal and lateral angulation for this technique.
PURPOSE: Long anchors projecting into the ilium provide optimal pelvic
fixation. A traditional starting point in the PSIS requires muscle dissection
and complex rod bends. Such obstacles may be reduced with a better-cov-
ered, more midline approach via a sacral starting point. We demonstrate
pathway parameters for insertion of iliac anchors through a sacral starting
point and compare it with insertion through the PSIS.
STUDY DESIGN/ SETTING: CT feasibility analysis of a new technique
for sacral pelvic fixation.
PATIENT SAMPLE: Twenty pelvic CTs of mature adolescents were an-
alyzed using INSPACE, a 3-D CT imaging program, by two surgeons.
METHODS: The CT imaging plane was manipulated until it provided
a trajectory with maximal length and width through the sacral ala and iliac
wing. The trajectory distance, starting point coordinates, angulation, depth,
and width were measured (Figure). The same parameters were evaluated
and compared for insertion from the PSIS.
RESULTS: Based on the ideal trajectory, the mean starting point was in
S2 25mm caudal to the superior endplate of S1 and 22mm lateral to the