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International Variations in the Clinical Presentation and Management of Cervical Spondylotic Myelopathy.
One Year Outcomes of the AOSpine Multi-Center Prospective Study.
On Behalf of the CSM-I Site Investigators : Michael Fehlings, MD, University of Toronto, Toronto, ON, Canada; Branko Kopjar, MD, University of Washington, Seattle, WA; Ronald Bartels, MD, University Nijmegen Medical Centre, Nijmegen, Netherlands; Vincenzo Albanese, PhD, Medical University of
Catania, Catania, Italy; Helton Defino, MD, University of Sao Paulo - Ribeirao Preto, Sao Paulo, Brazil; Paul Arnold, MD, University of Kansas, Kansas City; Qiang Zhou, MD, Southwestern Hospital,
ChongQing, China; Mehmet Zileli, MD, Ege University, Izmir, Turkey; Gamaliel Tan, MD, Tan Tock Seng Hospital, Singapore, Singapore; Osmar Moraes, MD, Hospital Santa Marcelina, Sao Paulo, Brazil;
Shashank Kale, MD, All India Institute of Medical Sciences, New Dehli India; Ciaran Bolger, MD, Beaumont Hospital, Dublin, Ireland; Manuel Alvarado, MD, Hospital San Juan de Dios, Caracas,
Venezuela; Massimo Scerrati, MD, Medical University of Ancona, Ancona, Italy
Giuseppe Barbagallo, MDUniversity of Catania, Catania, Italy
Background
Cervical spondylotic myelopathy (CSM) is the commonest cause of spinal cord impairment.
There is a lack of evidence regarding the long term outcomes of surgical treatment for CSM.
We report on the one year outcomes of a large prospective multicenter study to evaluate the impact of surgery on outcomes of CSM.
Patients
• 379 patients with clinically confirmed CSM and imaging evidence of cord compression (MRI or CT-myelogram) were enrolled in the prospective cohort study. Patients underwent anterior surgery (discectomy/corpectomy and instrumented fusion) or posterior surgery (laminectomy and fusion or laminoplasty) based on the judgment of the operating surgeon.
Subjects accounting
• 379 subjects were enrolled at 13 sites around the world.
• One year follow-up data are currently available for 193
subjects.
• Outcomes evaluations – modified Japanese Orthopaedic Assessment scale (mJOA),
Nurick Score, Neck Disability Index (NDI), Short Form-36v2, and an assessment of treatment complications.
Primary Investigators and Regions
Region City Primary Investigator
North AmericaToronto Dr. M. Fehlings
Kansas City Dr. P. Arnold
Asia / Pacific
ChongQing Dr. Q. Zhou
New Dehli Dr. S. Kale
Singapore Dr. G. Tan
Latin America
Ribeirao Preto Dr. H. Defino
Sao Paulo Dr. O. Moraes
Caracas Dr. M. Alvarado
Europe
Nijmegen Dr. R. Bartels
Izmir Dr. M. Zileli
Dublin Dr. C. Bolger
Catania Dr. G. Barbagallo
Ancona Dr. M. Scerrati
121
52
12581
Demographics
Variable Anterior (N=224) Posterior (N=144) Circumferential (N=9) P-value
Age 54.0±12.1 59.8±12.2 55.5±9.2 <.01
Male Gender 55.3% 73.5% 44.44% <.01
mJOA 12.9±2.1 11.9±2.9 12±2.8 <.01
Nurick 4.1±1.1 4.6±1.4 4.8±1.3 <.01
NDI 38.5±20.3 38.4±21.9 34.9±24.8 .84
SF36 V2 PCS 35.6±8.6 34.4±8.8 34.1±8.6 .30
SF36 V2 MCS 38.7±9.7 39.1±10.3 37.7±7.4 .91
Levels 2.95±.9 4.7±.9 3.9±0.9 <.01
12 months outcomes (N=193)
Variable Baseline 12 Months P value
mJOA 12.5±2.9 15.1±2.7 <.01
Nurick 4.3±1.2 2.9±1.5 <.01
NDI 38.2±20.9 26.7±19.1 <.01
SF36 PCS 35.1±8.6 43.2±10.1 <.01
SF36 MCS 38.8±9.9 45.2±10.6 <.01
12 months outcomes (N=193) - mJOA
Baseline 12 Months
mJOA 12.5 15.1
0
2
4
6
8
10
12
14
16
mJO
A
P<.01
Regional Differences in DemographicsVariable North
America(N =113)
Latin America(N =43)
Europe (N =123)
Asia pacific(N =57)
P value
Age 59.7±11.6 54.6±10.2 57.4±12.1 50.5±13.2 <.001Male Gender 57.0% 71.1% 59.3% 70.3% <.001Surgery <.001 Anterior 56.7% 23.1% 72% 67.5% Posterior 39.2% 76.9% 24.8% 32.5%Circumferential 4.1% 0% 3.2% 0%Number of levels 4.2±1.3 4.1±1.1 3.2±1.0 3.3±1.2 <.001
Variable North America Latin America Europe Asia Pacific P Value
MJOA 12.2±2.3 12.4±3.5 13.1±2.9 12.3±3.2 n.s.
NDI 37.6±21.7 39.1±20.6 37±20.7 41.9±20.3 n.s.
Nurick 4.2±1.0 4.4±1.6 4.2±1.2 4.6±1.4 n.s.
PCS 35.3±9.8 35.4±8.8 34.8±7.8 35.0±8.2 n.s.
MCS 39.2±10.4 41.8±11.2 37.9±8.8 37.8±9.4 n.s.
Regional Differences in Baseline Variables
Regional Differences in Outcomes
Variable North America Latin America Europe Asia Pacific P value
mJOA 2.76(0.29) 2.07(0.38) 1.30(0.28) 2.92(0.39) 0.0006NDI 7.21(2.42) 10.24(3.20) 8.23(2.28) 12.42(4.31) 0.7345
Nurick 1.56(0.17) 0.62(0.23) 1.18(0.16) 1.45(0.23) 0.0087PCS 6.06(1.22) 10.53(1.52) 4.58(1.12) 12.35(1.55) 0.0002MCS 5.04(1.30) 8.91(1.63) 3.17(1.19) 9.77(1.66) 0.0036
*Values in table show changes in outcome between baseline and 12 months adjusted for baseline predictors. Numbers in parenthesis are standard error.
• Surgical treatment for CSM results in sustained improvement in generic and disease HRQOL
• The amount of improvement varied across the regions. – Subjects from Asia & Pacific and Latin America had larger
improvements in outcome than those from North America and Europe.
– The impact of differences in age (much younger in Asia/Pacific) and socio-cultural perceptions of disability and impairment likely play a role in these observations
Discussion
Acknowledgements
• Study is funded by AOSpine International, a non-for-profit
organization for excellence in spine.