3. radiographic predictors of clinical outcomes following operative or non-operative treatment of...
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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.