International Variations in the Clinical Presentation and Management of Cervical Spondylotic Myelopathy. One Year Outcomes of the AOSpine Multi-Center.

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.