Surgical treatment for cervical spondylotic myelopathy. Initial 6

advertisement
International Variations in the Clinical Presentation
and Management of Cervical Spondylotic Myelopathy.
One Year Outcomes of the AOSpine Multi-Center Prospective Study.
Giuseppe Barbagallo, MD
University of Catania, Catania, Italy
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
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
North America
Asia / Pacific
Latin America
Europe
City
Primary
Investigator
Toronto
Dr. M. Fehlings
Kansas City
Dr. P. Arnold
ChongQing
Dr. Q. Zhou
New Dehli
Dr. S. Kale
Singapore
Dr. G. Tan
Ribeirao Preto
Dr. H. Defino
Sao Paulo
Dr. O. Moraes
Caracas
Dr. M. Alvarado
Nijmegen
Dr. R. Bartels
Izmir
Dr. M. Zileli
Dublin
Dr. C. Bolger
Catania
Dr. G. Barbagallo
Ancona
Dr. M. Scerrati
125
121
81
52
Demographics
Variable
Age
Anterior (N=224)
Posterior (N=144)
Circumferential (N=9)
P-value
54.0±12.1
59.8±12.2
55.5±9.2
<.01
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
Male Gender
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
16
P<.01
14
12
mJOA
10
8
6
4
2
0
mJOA
Baseline
12 Months
12.5
15.1
Regional Differences in Demographics
Variable
Age
Male Gender
Surgery
Anterior
Posterior
Circumferential
Number of levels
North
America
(N =113)
Latin America
(N =43)
Europe
(N =123)
Asia pacific
(N =57)
P value
59.7±11.6
57.0%
54.6±10.2
71.1%
57.4±12.1
59.3%
50.5±13.2
70.3%
<.001
<.001
<.001
56.7%
39.2%
4.1%
4.2±1.3
23.1%
76.9%
0%
4.1±1.1
72%
24.8%
3.2%
3.2±1.0
67.5%
32.5%
0%
3.3±1.2
<.001
Regional Differences in Baseline Variables
Variable
North America
Latin America
Europe
Asia Pacific
P Value
MJOA
NDI
12.2±2.3
37.6±21.7
12.4±3.5
39.1±20.6
13.1±2.9
37±20.7
12.3±3.2
41.9±20.3
n.s.
n.s.
Nurick
PCS
MCS
4.2±1.0
35.3±9.8
39.2±10.4
4.4±1.6
35.4±8.8
41.8±11.2
4.2±1.2
34.8±7.8
37.9±8.8
4.6±1.4
35.0±8.2
37.8±9.4
n.s.
n.s.
n.s.
Regional Differences in Outcomes
Variable
North America
Latin America
Europe
Asia Pacific
P value
mJOA
NDI
2.76(0.29)
7.21(2.42)
2.07(0.38)
10.24(3.20)
1.30(0.28)
8.23(2.28)
2.92(0.39)
12.42(4.31)
0.0006
0.7345
Nurick
PCS
MCS
1.56(0.17)
6.06(1.22)
5.04(1.30)
0.62(0.23)
10.53(1.52)
8.91(1.63)
1.18(0.16)
4.58(1.12)
3.17(1.19)
1.45(0.23)
12.35(1.55)
9.77(1.66)
0.0087
0.0002
0.0036
*Values in table show changes in outcome between baseline and 12 months adjusted for baseline
predictors. Numbers in parenthesis are standard error.
Discussion
• 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
Acknowledgements
• Study is funded by AOSpine International, a non-for-profit
organization for excellence in spine.
Download