2. predominant leg pain is associated with better surgical outcomes in degenerative...

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Wednesday, October 15, 2008 7:30–8:30 AM General Session: Best Papers 1. Clinical Instinct vs. Standardized Questionnaire: The Spine Specialists Ability to Detect Psychological Distress Michael Daubs, MD, Alpesh Patel, MD, Stewart Willick, MD, Kendall Richard, DO, Pamela Hansen, MD, David Petron, MD, Darrel S. Brodke, MD; University of Utah, Department of Orthopaedic Surgery, Salt Lake City, UT, USA BACKGROUND CONTEXT: The significant impact of psychosocial factors on treatment outcomes is well known. Psychological distress has been shown to be a predictor for poor surgical outcomes with spinal sur- gery. A majority of spine specialists do not use a validated patient reported (PR) screening questionnaire to assess psychological distress, but instead rely on their clinical instincts when evaluating patients. The Distress Risk Assessment Method (DRAM) is a well validated PR questionnaire used to assess levels of psychological distress. PURPOSE: To evaluate the Spine Specialists ability to accurately assess psychological distress. STUDY DESIGN/ SETTING: Prospective, blinded. PATIENT SAMPLE: 400 patients presenting for initial clinical evaluation at a comprehensive University Spine Center. OUTCOME MEASURES: DRAM (Distress Risk Assessment Method). METHODS: A prospective, blinded study consisting of 400 patients pre- senting to a University Spine Center for the evaluation of a spinal disorder and 8 physicians (4 spinal surgeons, 4 physiatrists) was performed to eval- uate spine specialists ability to assess levels of psychological distress. All new patients completed a DRAM questionnaire prior to being clinically evaluated. The physicians, blinded from the results of the DRAM, per- formed their routine clinical evaluation and categorized the patients level of psychological distress into one of the four DRAM categories: N, Nor- mal; AR, At-risk; DD, Distressed Depressive; and DS, Distressed Somatic. The spine specialists ability to correctly assess psychological distress as compared to the DRAM score was recorded. Comparison in accuracy of assessments between surgeons, non-operative spine specialists, less expe- rienced surgeons ( !2 years) and more experienced surgeons ( O10 years) were made. RESULTS: Thirty-seven percent (146/400) of the new patients were cat- egorized as Normal; 42% (167/400) At-Risk; 13% (51/400) Distressed Depressed; and 9%(36/400) Distressed Somatic. As a group, physicians correctly assessed patients 44% of the time (kappa .15). Surgeons were correct 40% of the time and non-op specialists 49% (p50.08). Non-op spine specialists were better at discerning patients who were AR(p50.004) and DS(p50.006) compared to surgeons. Surgeon experience was not a signif- icant factor (p O0.05). If grouped into 2 categories, (N-AR) and (DD-DS), the physicians as a group were correct 77% of the time (Kappa .23), sur- geons 76% and non-op 80% (p5.30). Non-op specialists were better at de- tecting patients in the more distressed categories (DD-DS), 42% agreement versus the surgeons 20% (p50.03). CONCLUSIONS: A large number of patients with spinal disorders have significant psychological distress. Spine specialists as a group are poor at clinically assessing psychological distress. Psychological distress is a pre- dictor for poor treatment outcomes. Validated PR questionnaires, such as the DRAM, that assess psychological distress should be used routinely. The results of these questionnaires should be one of the factors considered when making operative and non-operative treatment decisions. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi:10.1016/j.spinee.2008.06.002 2. Predominant Leg Pain is Associated with Better Surgical Outcomes in Degenerative Spondylolisthesis and Spinal Stenosis Adam Pearson, MD 1 , Emily Blood, MS 1 , Jon Lurie, MD 1 , Dilip Sengupta, MD 1 , William Abdu, MD 1 , Serena Hu, MD 2 , Michael Longley, MD 3 , Lawrence Lenke, MD 4 , James Weinstein, DO 1 ; 1 Dartmouth College, Lebanon, NH, USA; 2 University of California San Francisco, San Francisco, CA, USA; 3 Nebraska Foundation for Spinal Research, Omaha, NE, USA; 4 Washington University in St. Louis, Saint Louis, MO, USA BACKGROUND CONTEXT: Anecdotal evidence suggests that degener- ative spondylolisthesis (DS) and spinal stenosis (SpS) patients with pre- dominant leg pain have better surgical outcomes than patients with predominant back symptoms. PURPOSE: To compare baseline characteristics and surgical and non- operative outcomes in DS and SpS patients stratified by location of predominant pain (leg vs. back). STUDY DESIGN/ SETTING: The Spine Patient Outcomes Research Trial (SPORT) included randomized and observational cohorts, with 13 participating institutions in 11 states. PATIENT SAMPLE: 591 DS and 615 SpS patients. OUTCOME MEASURES: SF-36 Bodily Pain (BP) and Physical Func- tion (PF) scores, Oswestry Disability Index (ODI), and Stenosis Bother- someness Index (SBI). METHODS: All patients had neurogenic claudication and/or radicular symptoms. Patients with leg pain more severe than back pain (0–6 point scale) were classified as leg pain predominant, those with back pain more severe than leg pain as back pain predominant, and those with equivalent leg and back pain as equal pain. Baseline characteristics were compared between the three groups within each diagnostic category, and changes in surgical and non-operative outcome scores were compared at 2 years. Longitudinal regression models including baseline covariates were used to control for confounders in an as-treated analysis. RESULTS: Among DS patients at baseline, 34% had predominant leg pain, 40% had equal pain, and 26% had predominant back pain. Similarly, 32% of SpS patients had predominant leg pain, 42% equal pain, and 26% predominant back pain. Compared to patients with predominant back pain and equal pain, DS patients with predominant leg pain had baseline scores indicative of less severe symptoms: BP (33.6 leg, 27.9 equal, 32.2 back; p !0.001), PF (39.0 leg, 30.2 equal, 33.8 back; p !0.001), and ODI (38.7 leg, 44.0 equal, 42.4 back; p50.002). Among SpS patients, those with pre- dominant leg pain also had baseline scores indicative of less severe symp- toms compared to those with equal or predominant back pain: PF (37.9 leg, 31.8 equal, 35.1 back; p50.02) and ODI (38.1 leg, 45.8 equal, 42.8 back; p !0.001). Leg pain predominant DS patients treated surgically improved significantly more than back pain predominant patients at 2 years: BP (+37.0 leg, +29.6 equal, +23.6 back; p ! 0.01), PF (+33.5 leg, +25.2 equal, +20.8 back; p !0.01), ODI (29.6 leg, 23.1 equal, 20.3 back; p ! 0.01) and SBI (11.1 leg, 8.6 equal, 6.9 back; p !0.01). A similar pattern was seen for SpS patients at 2 years: BP (+32.4 leg, +26.8 equal, +19.4 back; p ! 0.01), PF (+29.6 leg, +20.7 equal, +17.4 back; p ! 0.01), ODI (25.4 leg, 18.9 equal, 16.4 back; p ! 0.01) and SBI (9.1 leg, 7.4 equal, 7.2 back; p50.04). Surgical outcomes for the equal pain groups were intermediate to those of the predominant leg and predominant back The Spine Journal 8 (2008) 1S–191S

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Page 1: 2. Predominant Leg Pain is Associated with Better Surgical Outcomes in Degenerative Spondylolisthesis and Spinal Stenosis

The Spine Journal 8 (2008) 1S–191S

Wednesday, October 15, 20087:30–8:30 AM

General Session: Best Papers

1. Clinical Instinct vs. Standardized Questionnaire: The Spine

Specialists Ability to Detect Psychological Distress

Michael Daubs, MD, Alpesh Patel, MD, Stewart Willick, MD,

Kendall Richard, DO, Pamela Hansen, MD, David Petron, MD, Darrel

S. Brodke, MD; University of Utah, Department of Orthopaedic Surgery,

Salt Lake City, UT, USA

BACKGROUND CONTEXT: The significant impact of psychosocial

factors on treatment outcomes is well known. Psychological distress has

been shown to be a predictor for poor surgical outcomes with spinal sur-

gery. A majority of spine specialists do not use a validated patient reported

(PR) screening questionnaire to assess psychological distress, but instead

rely on their clinical instincts when evaluating patients. The Distress Risk

Assessment Method (DRAM) is a well validated PR questionnaire used to

assess levels of psychological distress.

PURPOSE: To evaluate the Spine Specialists ability to accurately assess

psychological distress.

STUDY DESIGN/ SETTING: Prospective, blinded.

PATIENT SAMPLE: 400 patients presenting for initial clinical evaluation

at a comprehensive University Spine Center.

OUTCOME MEASURES: DRAM (Distress Risk Assessment Method).

METHODS: A prospective, blinded study consisting of 400 patients pre-

senting to a University Spine Center for the evaluation of a spinal disorder

and 8 physicians (4 spinal surgeons, 4 physiatrists) was performed to eval-

uate spine specialists ability to assess levels of psychological distress. All

new patients completed a DRAM questionnaire prior to being clinically

evaluated. The physicians, blinded from the results of the DRAM, per-

formed their routine clinical evaluation and categorized the patients level

of psychological distress into one of the four DRAM categories: N, Nor-

mal; AR, At-risk; DD, Distressed Depressive; and DS, Distressed Somatic.

The spine specialists ability to correctly assess psychological distress as

compared to the DRAM score was recorded. Comparison in accuracy of

assessments between surgeons, non-operative spine specialists, less expe-

rienced surgeons (!2 years) and more experienced surgeons (O10 years)

were made.

RESULTS: Thirty-seven percent (146/400) of the new patients were cat-

egorized as Normal; 42% (167/400) At-Risk; 13% (51/400) Distressed

Depressed; and 9%(36/400) Distressed Somatic. As a group, physicians

correctly assessed patients 44% of the time (kappa .15). Surgeons were

correct 40% of the time and non-op specialists 49% (p50.08). Non-op spine

specialists were better at discerning patients who were AR(p50.004) and

DS(p50.006) compared to surgeons. Surgeon experience was not a signif-

icant factor (pO0.05). If grouped into 2 categories, (N-AR) and (DD-DS),

the physicians as a group were correct 77% of the time (Kappa .23), sur-

geons 76% and non-op 80% (p5.30). Non-op specialists were better at de-

tecting patients in the more distressed categories (DD-DS), 42% agreement

versus the surgeons 20% (p50.03).

CONCLUSIONS: A large number of patients with spinal disorders have

significant psychological distress. Spine specialists as a group are poor at

clinically assessing psychological distress. Psychological distress is a pre-

dictor for poor treatment outcomes. Validated PR questionnaires, such as

the DRAM, that assess psychological distress should be used routinely.

The results of these questionnaires should be one of the factors considered

when making operative and non-operative treatment decisions.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi:10.1016/j.spinee.2008.06.002

2. Predominant Leg Pain is Associated with Better Surgical

Outcomes in Degenerative Spondylolisthesis and Spinal Stenosis

Adam Pearson, MD1, Emily Blood, MS1, Jon Lurie, MD1, Dilip Sengupta,

MD1, William Abdu, MD1, Serena Hu, MD2, Michael Longley, MD3,

Lawrence Lenke, MD4, James Weinstein, DO1; 1Dartmouth College,

Lebanon, NH, USA; 2University of California San Francisco, San

Francisco, CA, USA; 3Nebraska Foundation for Spinal Research, Omaha,

NE, USA; 4Washington University in St. Louis, Saint Louis, MO, USA

BACKGROUND CONTEXT: Anecdotal evidence suggests that degener-

ative spondylolisthesis (DS) and spinal stenosis (SpS) patients with pre-

dominant leg pain have better surgical outcomes than patients with

predominant back symptoms.

PURPOSE: To compare baseline characteristics and surgical and non-

operative outcomes in DS and SpS patients stratified by location of

predominant pain (leg vs. back).

STUDY DESIGN/ SETTING: The Spine Patient Outcomes Research

Trial (SPORT) included randomized and observational cohorts, with 13

participating institutions in 11 states.

PATIENT SAMPLE: 591 DS and 615 SpS patients.

OUTCOME MEASURES: SF-36 Bodily Pain (BP) and Physical Func-

tion (PF) scores, Oswestry Disability Index (ODI), and Stenosis Bother-

someness Index (SBI).

METHODS: All patients had neurogenic claudication and/or radicular

symptoms. Patients with leg pain more severe than back pain (0–6 point

scale) were classified as leg pain predominant, those with back pain more

severe than leg pain as back pain predominant, and those with equivalent

leg and back pain as equal pain. Baseline characteristics were compared

between the three groups within each diagnostic category, and changes

in surgical and non-operative outcome scores were compared at 2 years.

Longitudinal regression models including baseline covariates were used

to control for confounders in an as-treated analysis.

RESULTS: Among DS patients at baseline, 34% had predominant leg

pain, 40% had equal pain, and 26% had predominant back pain. Similarly,

32% of SpS patients had predominant leg pain, 42% equal pain, and 26%

predominant back pain. Compared to patients with predominant back pain

and equal pain, DS patients with predominant leg pain had baseline scores

indicative of less severe symptoms: BP (33.6 leg, 27.9 equal, 32.2 back;

p!0.001), PF (39.0 leg, 30.2 equal, 33.8 back; p!0.001), and ODI (38.7

leg, 44.0 equal, 42.4 back; p50.002). Among SpS patients, those with pre-

dominant leg pain also had baseline scores indicative of less severe symp-

toms compared to those with equal or predominant back pain: PF (37.9 leg,

31.8 equal, 35.1 back; p50.02) and ODI (38.1 leg, 45.8 equal, 42.8 back;

p!0.001). Leg pain predominant DS patients treated surgically improved

significantly more than back pain predominant patients at 2 years: BP

(+37.0 leg, +29.6 equal, +23.6 back; p!0.01), PF (+33.5 leg, +25.2 equal,

+20.8 back; p!0.01), ODI (�29.6 leg, �23.1 equal, �20.3 back; p!0.01)

and SBI (�11.1 leg, �8.6 equal, �6.9 back; p!0.01). A similar pattern

was seen for SpS patients at 2 years: BP (+32.4 leg, +26.8 equal, +19.4

back; p!0.01), PF (+29.6 leg, +20.7 equal, +17.4 back; p!0.01), ODI

(�25.4 leg, �18.9 equal, �16.4 back; p!0.01) and SBI (�9.1 leg, �7.4

equal, �7.2 back; p50.04). Surgical outcomes for the equal pain groups

were intermediate to those of the predominant leg and predominant back

Page 2: 2. Predominant Leg Pain is Associated with Better Surgical Outcomes in Degenerative Spondylolisthesis and Spinal Stenosis

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.