2S Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S
pain groups. Similar non-operative outcomes were observed for the three
pain location groups at 2 years in both the DS and SpS cohorts.
CONCLUSIONS: Overall, surgery resulted in better outcomes compared
to non-operative treatment for all patients regardless of pain location.
However, predominant leg pain patients improved more with surgery than
predominant back pain patients.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi:10.1016/j.spinee.2008.06.003
3. Radiographic Predictors of Clinical Outcomes Following
Operative or Non-Operative Treatment of Degenerative
Spondylolisthesis
Adam Pearson, MD1, Jon Lurie, MD1, Emily Blood, MS1, John Frymoyer,
MD1, Heike Braeutigam, MD1, Howard An, MD2, Federico Girardi, MD3,
James Weinstein, DO1; 1Dartmouth College, Lebanon, NH, USA;2Chicago, IL, USA; 3New York, NY, USA
BACKGROUND CONTEXT: It has been suggested that certain radio-
graphic features (i.e. magnitude of slip, disk space narrowing, and interver-
tebral hypermobility) are related to outcomes in degenerative
spondylolisthesis (DS).
PURPOSE: This study evaluated whether baseline radiographic findings
predicted outcomes in patients with degenerative spondylolisthesis (DS).
STUDY DESIGN/ SETTING: The Spine Patient Outcomes Research
Trial (SPORT) included randomized and observational cohorts, with 13
participating institutions in 11 states.
PATIENT SAMPLE: 222 DS patients with radiographs available for re-
view, representing a subset of the total cohort of 591 DS patients
OUTCOME MEASURES: SF-36 bodily pain (BP) and physical function
(PF) scales, Oswestry disability index (ODI), stenosis bothersomeness in-
dex (SBI), and low back pain bothersomeness scale
METHODS: Using the SPORT DS cohorts, we analyzed the data accord-
ing to treatment received. The Meyerding listhesis grade was determined
on the neutral radiograph (n5222). A patient was classified as having
low disk height if the disk height was less than 5 mm. Flexion-extension
radiographs (n5185) were evaluated for mobility. Those with greater than
10� rotation or 4 mm translation were considered Hypermobile. Changes in
outcome measures were compared between listhesis (Grade 1 vs. Grade 2),
disk height (Low vs. Normal) and mobility (Stable vs. Hypermobile)
groups using longitudinal regression models adjusted for potential
confounders.
RESULTS: Overall, 86% had a Grade 1 listhesis, 78% had Normal disk
height, and 73% were Stable. Baseline symptom severity was similar be-
tween the groups. Overall, surgery patients improved more than patients
treated non-operatively. At one year, outcomes were similar in surgery pa-
tients across listhesis, disk height, and mobility groups (ODI: Grade 1
�23.7 vs. Grade 2 �23.3, p50.90; Normal disk height �23.5 vs. Low disk
height �21.9, p50.66; Stable �21.6 vs. Hypermobile �25.2, p50.30).
Among those treated non-operatively, Grade 1 patients improved more
than Grade 2 patients (BP +13.1 vs. �4.9, p50.019; ODI �8.0 vs. +4.8,
p50.010 at 1 year), and Hypermobile patients improved more than Stable
patients (ODI �15.2 vs �6.6, p50.041; SBI �7.8 vs �2.7, p50.002 at 1
year).
CONCLUSIONS: Regardless of listhesis grade, disk height or mobility,
patients who had surgery improved more than those treated non-opera-
tively. Surgical treatment effects were greater for Grade 2 patients and
for Stable patients. These differences were due, in part, to differences in
non-operative outcomes, which were better in patients classified as Grade
1 or Hypermobile.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi:10.1016/j.spinee.2008.06.004
4. This paper will be presented during the TSJ Outstanding Paper
Awards presentations Thursday morning, October 16, 2008.
5. Outcome of Lumbar Fusion in Patients Over 65 Years Old
Steven Glassman, MD1, David Polly, Jr., MD2, Christopher Bono, MD3,
Kenneth Burkus, MD4, John Dimar, II, MD5; 1Leatherman Spine Center,
Louisville, KY, USA; 2University of Minnesota, Minneapolis, MN, USA;3Boston, MA, USA; 4Hughston Clinic, PC, Columbus, GA, USA;5Louisville, KY, USA
BACKGROUND CONTEXT: Most of the literature regarding lumbar fu-
sion in older patients has focused on the rate of complications. In 2006,
a CMS advisory panel meeting assessing evidence for spinal fusion surgery
in the Medicare population indicated a need for ‘‘better evidence to con-
clusively demonstrate improvement in health outcomes’’. Additionally,
the panel noted that the majority of evidence was in younger patients
and that it was unclear whether this data could be applied to the Medicare
population.
PURPOSE: The purpose of this study is to compare clinical outcomes for
lumbar fusion in older versus younger patients, within a clearly defined
study population.
STUDY DESIGN/ SETTING: Patients were treated as part of an IRB ap-
proved, FDA regulated, randomized, nonblinded IDE trial of rhBMP-2 ma-
trix for posterolateral lumbar spine fusion. The patients were those
randomized to the control arm (ICBG) of the IDE trial. Inclusion criteria
for this study were single level lumbar DDD in patients over 18 yrs of
age with no greater than Grade I spondylolisthesis.
PATIENT SAMPLE: 224 patients who underwent single-level posterolat-
eral lumbar fusion with ICBG.
OUTCOME MEASURES: ODI, SF-36, Numeric Rating Scales for Back
Pain and Leg Pain, and radiographic fusion.
METHODS: Outcomes were compared for 50 patients over 65 yrs of
age (mean 70.5 yrs) and 174 patients under 65 yrs of age (mean 47.0
yrs). Change in outcome measures were evaluated based upon both net
mean change and the percentage of patients reaching an MCID threshold.
Published MCID thresholds of 5.42 pts for SF-36 PCS and 10 pts for
ODI were utilized. Fusion was assessed by plain radiographs and CT
scans.
RESULTS: Statistically significant improvements from baseline were
noted in all of the HRQOL measures at the six month, one year and
two yearr post-op intervals. Mean improvements in ODI at two years
post-op were 28.5 in older patients and 24.5 in younger patients. Older
patients performed better at all time intervals, though only the six month
difference between groups was significant (p50.041), after adjusting for
preoperative ODI score. For the SF-36 PCS, mean improvement from
pre-op baseline was 14.2 in the over 65 group and 11.7 in the under
65 group at two years. Older patients also demonstrated a greater im-
provement in back pain NRS scores at all time intervals with the differ-
ence at six months being statistically significant and the difference at two
years post-op trending towards significance (8.8 vs. 7.7, p50.077). Leg
pain NRS scores were also better in older patients at all time intervals,
with the difference at two years post-op being statistically significant
(10.4 pts vs. 6.4 pts, p50.002). Percentage of patients reaching MCID
was also higher in the older group than the younger group at all time in-
tervals. At two years after surgery, a decrease in ODI score of 10 pts or
greater was achieved in 85.0% of older patients and 72.7% of younger
patients. Improvement of 5.42 pts or more in SF-36 PCS was observed
in 75.0% of older patients and 63.6% of younger patients. Successful
fusion was seen in 94.7% of patients over 65 years old and 87.7% of
patients under 65 years old.
CONCLUSIONS: This study demonstrates substantial benefit for
a Medicare age population treated by single-level lumbar decompression
and instrumented fusion. This improvement is evident both in compar-
ison to literature standards and to a control population of younger
patients.
3SProceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi:10.1016/j.spinee.2008.06.006
6. Outcomes Based on a Low Back Pain Classification System
Greg McIntosh, MSC1, Hamilton Hall, MD2, Christina Boyle, BSC3;1Oakville, Ontario, Canada; 2Markdale, Ontario, Canada; 3Toronto,
Ontario, Canada
BACKGROUND CONTEXT: One goal of LBP assessment is to direct
clinicians to specific sub-groups that benefit from particular treatment ap-
proaches. The term ’non-specific’ LBP does not direct treatment or instil
confidence in patients.
PURPOSE: The purpose of this study was to compare outcomes in a con-
servative care setting between patients assessed and treated based on a di-
agnostic system of LBP classification and patients managed without
a classification system.
STUDY DESIGN/ SETTING: This prospective double-cohort study
investigated mechanical LBP cases who started conservative care rehabil-
itation at 15 clinics across Canada between February 2006 and August
2007.
PATIENT SAMPLE: The two cohorts were: a Comparison Group
(n5754) and a Classification Group (n51469). All patients in both groups
had mechanical LBP. The Comparison Group contained those attending
treatment at 8 clinics that did not use a classification based system of as-
sessment or treatment. The Classification Group (n51356) consisted of pa-
tients attending 7 clinics specifically trained to use a LBP classification
system that emphasizes mechanical assessment, pattern of pain recognition
and appropriate treatment direction.
OUTCOME MEASURES: Primary outcomes assessed were: 1) subjec-
tive global pain rating, 2) change in reported medication usage from as-
sessment to discharge, 3) change in Visual Analogue Scale (VAS) pain
rating from assessment to discharge, 4) change in perceived function from
assessment to discharge, based on score change from a modified version of
the Low Back Outcome Score (LBOS) and 5) total number of treatment
days.
METHODS: The classification system is purposely as inclusive as possi-
ble to include more than those who may get labelled with NSLBP; thus,
very little study exclusion criteria were necessary. Those over 65 years
of age and those with neurological, reflex or strength deficits were included
because there are specific categories for those where age or signs of nerve
root compromise contribute to their condition. Only minors, those with
previous spine surgery and those with suspected systemic disease or cases
resulting from trauma sufficient to produce severe bony injury or major
neurological sequelae were excluded. Patients were either self-referred
to the clinics or referred via general practice, family physicians or ortho-
paedic surgeons. All clinics involved in this study are primary access, con-
servative care, rehabilitation facilities.
RESULTS: For both Comparison and Classification Groups, the mean
age was 44.7 years (SD513.3, range518–89,), with 55.1% males. The
mean lagtime from symptom onset to treatment was 110.7 days
(SD5201.5), indicating a somewhat chronic sample; however, this vari-
able did not follow a normal distribution. Median values (32 days, inter-
quartile range59.5, 121.5 days) suggest a more subacute sample.
Treatment based on this classification system resulted in more pain reduc-
tion (p!0.001), higher functional improvement (p!0.001), less medica-
tion use (p!0.001) and fewer treatment days (p!0.001), compared to
a generic approach.
CONCLUSIONS: Outcome differences between the five classified
groups suggest that LBP is heterogeneous, and recognizable by clinical
patterns of patient characteristics. The results support the effectiveness
of a classification system that matches treatment to patient presentation
and pattern of pain. Classification-based treatment had a positive impact
on outcomes.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi:10.1016/j.spinee.2008.06.007
7. Spinal Stenosis vs. Degenerative Spondylolisthesis: Comparison of
Baseline Characteristics and Outcomes
Adam Pearson, MD1, Emily Blood, MS2, Jon Lurie, MD1, Tor Tosteson,
PhD1, Alan Hillibrand, MD3, Keith Bridwell, MD4, James Weinstein, DO2;1Dartmouth College, Lebanon, NH, USA; 2Lebanon, NH, USA; 3Rothman
Institute, Philadelphia, PA, USA; 4Washington University in St. Louis, St.
Louis, MO, USA
BACKGROUND CONTEXT: Spinal stenosis (SpS) and degenerative
spondylolisthesis (DS) patients are often combined in clinical studies. This
study contrasts these two distinct cohorts from the Spine Patient Outcomes
Research Trial (SPORT).
PURPOSE: To compare baseline characteristics and surgical and non-op-
erative outcomes between SpS and DS patients.
STUDY DESIGN/ SETTING: The Spine Patient Outcomes Research
Trial (SPORT) included randomized and observational cohorts, with 13
participating institutions in 11 states.
PATIENT SAMPLE: 615 SpS and 591 DS patients.
OUTCOME MEASURES: SF-36 Bodily Pain and Physical Function
scores, Oswestry Disability Index , Sciatica Bothersomeness Index, and
Back Pain Bothersomeness.
METHODS: The SPORT SpS cohort included 634 patients (394
underwent surgery within two years), and the DS cohort included 601
patients (369 underwent surgery within two years). Baseline characteris-
tics were compared between the two groups. Changes from baseline for
surgical and non-operative outcomes were estimated using longitudinal
regression models including baseline covariates to control for
confounders.
RESULTS: The SpS patients included a higher proportion of males
(61% vs. 31%, p!0.001); were younger (64.6 years vs. 66.1 years,
p50.021); were less likely to report depression (11% vs. 16%,
p50.009); more likely to report heart (26% vs. 20%, p50.021) or gastro-
intestinal (14% vs. 7%, p!0.001) problems; and were more likely to
have stenosis at multiple levels (61% vs. 35%, p!0.001) compared to
the DS patients. There were no significant baseline differences on any
of the main outcome measures between the SpS and DS patients. SpS
patients undergoing surgery were less likely to be fused than DS patients
(11% vs 95%, p!0.001). SpS patients improved less with surgery than
DS patients on SF-36 physical function (+25.1 vs. +30.5, p50.002 at
1 yr; +25.9 vs. +31.2, p50.001 at 2 yrs) and bodily pain (+27.2 vs.
+32.5, p50.002 at 1 yr; +21.2 vs. +28.4, p!0.001 at 2 yrs) scores, Os-
westry Disability Index (�20.8 vs. �26.1, p!0.001 at 1 yr; �20.1 vs.
�24.8, p!0.001 at 2 yrs), and Sciatica Bothersomeness Index (�8.4
vs. �9.4, p50.05 at 1 yr; �7.9 vs. �8.9, p50.031 at 2 yrs). Back Pain
Bothersomeness improved less in SpS patients at 1 yr (�2.0 vs. �2.4,
p50.012), though the difference was no longer significant at 2 yrs
(�2.0 vs. �2–2, p50.21). In both cohorts, patients treated non-opera-
tively improved less than those treated surgically, and there were no sig-
nificant differences in non-operative outcomes between the two cohorts at
one or two years.
CONCLUSIONS: Overall, SpS and DS patients had similar baseline
characteristics. However, SpS patients improved less with surgery than
DS patients. These differences in surgical outcomes may be related to
different underlying disease processes, different operative treatments or
both. Future studies should not combine these heterogeneous patient
populations.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi:10.1016/j.spinee.2008.06.008