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144 J Neurosurg: Spine / Volume 13 / August 2010
The incidence of complications in spinal surgery remains unclear. Authors of previous reports have surmised that between 10 and 20% of patients un-
dergoing surgical spinal procedures suffer adverse events or complications.29,51,53 Most spinal literature consists of retrospective analyses that are assumed to underestimate the complication incidence. In the present study we as-sessed the different rates of complications reported in prospective and retrospective analyses of spine surgery complications through a systematic review of the spine surgery literature.
Many factors may contribute to this divergence in complication incidence. The very definition of a com-plication in spine surgery is unclear, as is the relevance of purely medical perioperative adverse events to any discussion of complication incidence.75 Medical comor-bidities, advanced patient age, and body mass index can contribute to complication incidence, although authors have presented conflicting data.38,80 Ragab et al.80 report-
Complications in spine surgery
A reviewRani nasseR, B.s.,1 sanjay yadla, M.d.,2 Mitchell G. MaltenfoRt, Ph.d.,2 jaMes s. haRRoP, M.d.,2 d. GReG andeRson, M.d.,3 alexandeR R. VaccaRo, M.d., Ph.d.,3 ashwini d. shaRan, M.d.,2 and john K. Ratliff, M.d.2
1Temple University School of Medicine; and Departments of 2Neurosurgery and 3Orthopedic Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania
Object. The overall incidence of complications or adverse events in spinal surgery is unknown. Both prospec-tive and retrospective analyses have been performed, but the results have not been critically assessed. Procedures for different regions of the spine (cervical and thoracolumbar) and the incidence of complications for each have been re-ported but not compared. Authors of previous reports have concentrated on complications in terms of their incidence relevant to healthcare providers: medical versus surgical etiology and the relevance of perioperative complications to perioperative events. Few authors have assessed complication incidence from the patient’s perspective. In this report the authors summarize the spine surgery complications literature and address the effect of study design on reported complication incidence.
Methods. A systematic evidence-based review was completed to identify within the published literature com-plication rates in spinal surgery. The MEDLINE database was queried using the key words “spine surgery” and “complications.” This initial search revealed more than 700 articles, which were further limited through an exclusion process. Each abstract was reviewed and papers were obtained. The authors gathered 105 relevant articles detailing 80 thoracolumbar and 25 cervical studies. Among the 105 articles were 84 retrospective studies and 21 prospective studies. The authors evaluated the study designs and compared cervical, thoracolumbar, prospective, and retrospec-tive studies as well as the durations of follow-up for each study.
Results. In the 105 articles reviewed, there were 79,471 patients with 13,067 reported complications for an overall complication incidence of 16.4% per patient. Complications were more common in thoracolumbar (17.8%) than cervical procedures (8.9%; p < 0.0001, OR 2.23). Prospective studies yielded a higher incidence of complica-tions (19.9%) than retrospective studies (16.1%; p < 0.0001, OR 1.3). The complication incidence for prospective thoracolumbar studies (20.4%) was greater than that for retrospective series (17.5%; p < 0.0001). This difference between prospective and retrospective reviews was not found in the cervical studies. The year of study publication did not correlate with the complication incidence, although the duration of follow-up did correlate with the complica-tion incidence (p = 0.001).
Conclusions. Retrospective reviews significantly underestimate the overall incidence of complications in spine surgery. This analysis is the first to critically assess differing complication incidences reported in prospective and retrospective cervical and thoracolumbar spine surgery studies. (DOI: 10.3171/2010.3.SPINE09369)
Key woRds • spine surgery • complication • outcomes reporting • study methodology
This article contains some figures that are displayed in color on line but in black and white in the print edition.
J Neurosurg Spine 13:144–157, 2010See the corresponding editorial in this issue, pp 141–143.
J Neurosurg: Spine / Volume 13 / August 2010
Complications literature review
145
ed that comorbidities and advanced age did not increase morbidity or death. However, Glassman et al.38 noted that the incidence of complications after lumbar instrumenta-tion and fusion in patients with diabetes mellitus corre-lates with patient age. A retrospective review by Patel et al.75 documented a linear correlation between body mass index and complication incidence, although these obser-vations have not been confirmed by prospective studies.
Unfortunately, there are no accepted standards for outcome assessment in spine surgery, and thus relating the incidence of complications to overall operative outcomes is challenging.2,24,25 A better understanding of complica-tion incidence will aid in counseling patients and choos-ing an operative intervention.
Considerable interest in defining and limiting com-plication incidence has been expressed by federal agen-cies and third party payers. Rising healthcare costs pose significant concerns to system viability. Present reform efforts focus on improving outcomes while restricting costs. Recent federal healthcare policies restrict hospital reimbursements for certain preventable hospital-acquired conditions termed “never events.” These restrictions limit hospital reimbursement on diagnosis-related groups of pa-tients with select hospital-acquired conditions, including perioperative wound infections, deep venous thromboses, and falls. Further financial penalties aimed at limiting complications have been speculated to affect physician reimbursement.20,21
A systematic review of the spine surgery literature was performed to chronicle the incidence of complica-tions, to relate complication incidence to procedures performed (thoracolumbar versus cervical), to assess the impact of the year of study publication and follow-up duration on complication incidence, and to determine whether study design (prospective versus retrospective) affected the reported complication incidence. In addition, an assessment of the complication definitions used by the various studies was undertaken to find a consensus re-garding a definition of “complication.” A greater under-standing of complications incidence will aid in improving patient outcomes.
MethodsThe key words “spine surgery” and “complications”
were chosen, and a MEDLINE search was performed for the years from 1992 to 2008. Our initial search revealed approximately 780 articles focusing on spine surgery com-plications. We restricted our review by using only English language articles, concentrating on clinical studies that offered significant discussions of spine surgery complica-tions, and focusing on articles in which larger series were reported. We excluded all case reports, all small series (< 20 patients reported), all non–English language literature, and all series in which complication incidence and as-sessment were not clearly documented.
The assessment was restricted to 105 representative articles. We did not attempt to review all articles on spine surgery or all articles presenting a complication during the survey period. Generally, we limited our analysis to reviews with > 25 patients and to prospective studies of-
fering summations of complication data. We attempted to obtain articles featuring a wide spectrum of patient ages.
Eighty representative articles on complications of thoracolumbar procedures and 25 articles on complica-tions of cervical procedures met our inclusion criteria and were reviewed. In each article we noted the site of surgery (cervical or thoracolumbar), study design (prospective or retrospective), year of study publication, and duration of follow-up. When recorded, each study’s definition of an operative complication as well as the general approach to complication reporting was noted.
Statistical significance was assessed using t-tests for study variables and complication incidence. A p value was set at 0.05. The mean follow-up duration values were obtained from the individual reports. When study values were unclear or missing, they were omitted from our as-sessment. Logistic regressions were used to assess the im-pact of the year of study and study duration on the overall complication incidence. All analyses were performed us-ing JMP, version 7.0.2 (SAS Institute).
ResultsThe 105 studies contained 79,471 patients and 13,067
reported complications, yielding an overall complication incidence of 16.4%. Reviewed studies are summarized in Tables 1 and 2. Authors, study design, sample size, dura-tion of follow-up, and complications assessed are present-ed in the respective tables for thoracolumbar and cervical procedures.
Eighty thoracolumbar and 25 cervical studies were incorporated into our review. Prospective cervical and thoracolumbar studies comprised 20% of the assessed studies (16 of 80 thoracolumbar studies and 5 of 25 cer-vical studies). Sample sizes for the prospective cervical studies were smaller. Sample size and duration of follow-up varied widely (Tables 1 and 2).
Thoracolumbar procedures had a higher reported complication incidence than cervical procedures: 17.8% versus 8.9% (Fig. 1). A prospective study design yielded a higher incidence of complications (19.9% vs 16.1% in retrospective studies; Fig. 2). Study design predicted com-plication incidence in the surgical thoracolumbar studies (Fig. 3). Each of these differences was statistically signifi-cant (p < 0.001). Among cervical studies alone, the differ-ence between prospective and retrospective reviews did not reach statistical significance, probably because of the smaller number of patients in prospective cervical stud-ies in our analysis. The date of study publication failed to correlate with complication incidence (Fig. 4). Figure 5 shows that the follow-up duration correlated with compli-cation incidence, with longer follow-up studies evidencing higher complication incidences (p = 0.001, OR 0.987).
Approach methodology was available in 82 of the re-viewed articles. We did not find a correlation between ap-proach and complication incidence in the thoracolumbar studies, with a 19% complication rate noted in anterior procedures and an 18% complication rate in posterior approaches. There was a trend toward a higher compli-cation incidence in posterior cervical approaches, with an incidence of 9% in anterior procedures and 10.8% in
R. Nasser et al.
146 J Neurosurg: Spine / Volume 13 / August 2010
TABL
E 1:
Lite
ratu
re re
view
of t
hora
colu
mba
r stu
dies
*
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pa
tients
Dura
tion o
f St
udy/F
UIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d†Al
i et a
l., 20
03
retro
spec
tive r
eview
2838
mos
over
all, 1
7.8%
3.5%
intra
op co
mplic
ation
s; 14
.3% po
stop c
ompli
catio
ns: s
uper
ficial
wou
nd in
fectio
n (1),
dislo
dged
femo
ral
ring i
nterb
ody g
raft
(1), d
istal
juncti
onal
dege
nera
tion (
2)Ap
felba
um et
al.,
2000
re
trosp
ectiv
e rev
iew14
718
.2 m
osov
erall
, 13%
10%
hard
ware
failu
res,
2% ot
her c
ompli
catio
ns, 1
% de
aths
Barra
gán-
Camp
os
et al.
, 200
6 re
trosp
ectiv
e rev
iew11
730
days
over
all, 6
.8%1.7
% pu
nctur
e site
hema
toma,
3.4%
radic
ular p
ain, 1
.7% ce
ment
PE
Benz
et al
., 200
1 re
trosp
ectiv
e rev
iew68
42 m
osov
erall
, 40%
12%
serio
us co
mplic
ation
s, 1.4
% ea
rly m
orta
lity ra
teBe
rtagn
oli et
al.,
2005
pr
ospe
ctive
stud
y25
31 m
os
over
all, 8
%4%
subs
idenc
e of in
ferior
endp
late o
f L4–
5 seg
ment,
4% an
t extr
usion
of po
lyethy
lene c
ompo
nent
Bian
chi e
t al.,
2003
re
trosp
ectiv
e rev
iew72
12 m
osov
erall
, 12.
5%1.4
% sm
all bo
wel e
ntero
tomy,
1.4%
iliac
vein
lacer
ation
, 2.8%
erec
tile dy
sfunc
tion,
1.4%
lowe
r extr
emity
pare
-sis
, 1.4%
acute
chole
cysti
tis, 1
.4% fe
mora
l vein
thro
mbos
is, 1.
4% pn
eumo
nia, 1
.4% ac
ute M
I/CHF
Blum
enth
al et
al.,
2005
pr
ospe
ctive
, mult
i-ce
nter c
linica
l trial
30
424
mos
over
all, 5
3.5%
18.2
% pa
in at
bone
graf
t don
or si
te; de
vice f
ailur
es ne
cess
itatin
g reo
p, re
vision
, or r
emov
al in
5.4%
of in
vesti
-ga
tiona
l gro
up &
9.1%
of co
ntrols
; app
roac
h-re
lated
comp
licati
ons i
n 9.8%
of in
vesti
gatio
nal g
roup
& 10
.1%
of co
ntrols
Br
au, 2
002
retro
spec
tive r
eview
686
6 mos
over
all, 4
.8%0.
8% ar
terial
comp
licati
ons,
0.8%
veno
us in
juries
, 1%
DVT
, 0.1%
retro
grad
e ejac
ulatio
n, 0.6
% ile
us, 0
.4%
woun
d infe
ction
, 0.3%
hern
ia, 0.
6% ab
orted
case
s, 0.1
% M
I, 0.1%
death
Bridw
ell et
al.,
2003
retro
spec
tive r
eview
333.
5 yrs
over
all, 3
9%18
% th
orac
ic ps
euda
rthro
sis, 1
5% tr
ansie
nt ne
urolo
gical
defic
its (r
esolv
ed af
ter ce
ntral
cana
l enla
rgem
ent),
6%
acute
angu
lar ky
phos
is at
thor
acolu
mbar
junc
tion a
t pro
ximal
end o
f con
struc
tBu
tt et
al., 2
007
retro
spec
tive r
eview
5059
mos
over
all, 6
6%16
% sc
rew
loose
ned,
14%
bent
scre
ws, 1
0% br
oken
scre
ws, 6
% gr
aft s
ite in
fectio
n, 4%
supe
rficia
l wou
nd
infec
tion,
2% de
ep w
ound
infec
tion,
14%
UTI
Butto
n et a
l., 20
05
retro
spec
tive c
ohor
t stu
dy46
6 yrs
over
all, 3
0%13
% m
ajor p
eriop
comp
licati
ons:
lower
extre
mity
weak
ness
(2),
lower
extre
mity
numb
ness
(1),
pers
isten
t dys
-es
thes
ias in
lowe
r extr
emity
(1),
intra
ctable
pain
requ
iring h
ospit
al re
admi
ssion
(1),
avuls
ed an
t long
itudin
al lig
amen
t (1);
17%
mino
r per
iop co
mplic
ation
s: ile
us (5
), de
layed
wou
nd he
aling
(2),
urina
ry re
tentio
n (1)
Carb
one e
t al.,
2003
re
trosp
ectiv
e rev
iew41
15 m
osov
erall
, 9.7%
2.4%
instr
umen
tatio
n fail
ure,
2.4%
deep
infec
tion,
4.9%
supe
rficia
l infec
tion
Carre
on et
al.,
2003
re
trosp
ectiv
e rev
iew98
9.7
days
over
all, 7
0%
21%
majo
r com
plica
tions
, 50%
>1 co
mplic
ation
, 10%
wou
nd in
fecti
on, 3
4% U
TI
Cass
inelli
et al.
, 20
07
retro
spec
tive r
eview
166
3 mos
over
all, 3
3.1%
3%
majo
r com
plica
tions
(PE,
MI, r
etrop
erito
neal
hema
toma,
uros
epsis
, & ep
idura
l hem
atoma
), 30
% m
inor
comp
licati
ons
Dai e
t al.,
2004
re
trosp
ectiv
e rev
iew91
5.2 y
rsov
erall
, 56%
23%
pulm
onar
y, 1%
DVT
, 2%
pres
sure
sore
, 30%
UTI
Daub
s et a
l., 20
07re
trosp
ectiv
e rev
iew46
4.2 y
rsov
erall
, 37%
20%
majo
r com
plica
tion r
ate, 8
.6% ne
urolo
gical
defic
its, 4
.3% de
ep w
ound
infe
ction
, 2%
MI, P
E, &
pneu
monia
Dear
born
et al
., 19
99
retro
spec
tive r
eview
318
2 yrs
over
all, 2
.5%2.
2% sy
mptom
atic P
E, 0.
3% as
ympto
matic
iliac
vein
thro
mbos
is
Deyo
et al
., 199
2re
trosp
ectiv
e rev
iew18
,122
6 day
s18
% in
patie
nts
≥75 y
rsam
ong 1
8% w
/ com
plica
tions
: 10%
hemo
rrhag
e or h
emato
ma, 8
.9%
gastr
ointes
tinal
comp
licati
ons,
8.3%
ur
inary
trac
t com
plica
tions
, 8.4%
resp
irator
y com
plica
tions
, 4.8%
card
iac co
mplic
ation
s, 3.
6% po
stop i
nfec-
tions
(cont
inued
)
J Neurosurg: Spine / Volume 13 / August 2010
Complications literature review
147
TABL
E 1:
Lite
ratu
re re
view
of t
hora
colu
mba
r stu
dies
* (co
ntin
ued)
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pa
tients
Dura
tion o
f St
udy/F
UIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d†De
Wald
et al
., 20
06
retro
spec
tive r
eview
3830
mos
over
all, 3
9%
13%
pedic
le fra
cture
s or c
ompr
essio
n fra
cture
s, 26
% pr
ogre
ssive
junc
tiona
l kyp
hosis
at ce
phala
d exte
nt of
cons
truct
Eck e
t al.,
2001
re
trosp
ectiv
e rev
iew58
5 yrs
over
all, 2
7%
16%
posto
p dist
al sp
inal d
egen
erati
on, 5
% ps
euda
rthro
sis, 3
% de
ep w
ound
infec
tion,
3% cr
ossli
nk br
eaka
geEd
ward
s et a
l., 20
03re
trosp
ectiv
e rev
iew34
5.6 y
rsov
erall
, 32.
3%11
.8% ps
euda
rthro
sis, 2
.9%
loss
of fix
ation
, 11.8
% C
SJD
requ
iring a
rthro
desis
, 2.9
% L-
5 defi
cit, 2
.9%
supr
aja-
cent
trans
ition s
yndr
ome
Edwa
rds e
t al.,
2004
match
ed co
hort
analy
sisL-5
coho
rt:
28;
sacr
um
coho
rt:
12
4 yrs
L-5 co
hort:
ov
erall
, 22%
; sa
crum
co-
hort:
over
all,
75%
L-5 co
hort:
15%
dista
l tran
sition
synd
rome
, 4%
loss
fixati
on, 4
% ra
diculo
pathy
, 4%
supr
ajace
nt tra
nsitio
n sy
ndro
me, 4
% ps
euda
rthro
sis; s
acru
m co
hort:
42%
pseu
darth
rosis
, 33%
med
ical m
orbid
ity, 1
7% w
ound
inf
ectio
n, 8%
prox
imal
trans
ition s
yndr
ome
Emam
i et a
l., 20
02
retro
spec
tive r
eview
5457
mos
over
all, 4
8%
18.5%
pseu
darth
rosis
Ep
stein,
2001
retro
spec
tive r
eview
48 no
n-pla
ted
patie
nts,
35 pa
-tie
nts w
/ pla
ted
1-lev
el AC
F
nonp
lated
pa
tients
: 82
mos
; pla
ted
patie
nts:
21 m
os
nonp
lated
pa
tients
: ov
erall
, 10
.5%;
plated
pa
tients
: ov
erall
, 11
.5%
nonp
lated
patie
nts: 6
.3% im
media
te gr
aft e
xtrus
ions,
4.2%
symp
tomati
c pse
udar
thro
sis; p
lated
patie
nts: 2
.9%
pla
te dis
place
ment,
8.6%
symp
tomati
c pse
udar
thro
sis
Fritz
ell et
al., 2
002
pros
pecti
ve, m
ulti-
cente
r ran
dom
-ize
d tria
l
211
2 yrs
over
all, 2
4%
6% ne
w leg
pain
imme
diatel
y afte
r sur
gery
; 1.4%
deep
early
wou
nd in
fectio
n
Glas
sman
et al
., 20
03
retro
spec
tive c
ase-
contr
ol stu
dy94
2 yrs
over
all, 5
3%
in pa
tients
w/
NID
DM,
56%
in
patie
nts w
/ ID
DM, 2
1%
in pa
tients
w/
o DM
signifi
cantl
y gre
ater n
onun
ion ra
te in
NIDD
M (2
2%) &
IDDM
(26%
) gro
ups c
ompa
red w
/ con
trols
(5%)
Goule
t et a
l., 19
97
retro
spec
tive r
eview
170
56 m
osov
erall
, 24.
2%0.6
% ili
ac cr
est a
bsce
ss, 1
.8% su
perfi
cial in
fectio
ns, 1
6.5%
pain
in ilia
c cre
st, 3.
5% su
perfi
cial w
ound
prob
-lem
s, 1.2
% ke
loids
, 0.6%
numb
ness
Guigu
i et a
l., 20
05
pros
pecti
ve, m
ulti-
cente
r obs
erva
-tio
nal s
tudy
3311
1 yr
over
all, 2
1.3%
5.7
% ge
nera
l, 4.7%
infec
tious
, 11.5
% m
echa
nical,
1.8%
neur
ologic
al
Gumb
s et a
l., 20
05
retro
spec
tive r
eview
644 d
ays
over
all, 2
5%3%
inab
ility t
o com
plete
proc
edur
e, 3%
intra
op va
scula
r injur
y, 1%
urete
ral in
jury,
14%
posto
p fev
er, 3%
spina
l he
adac
hes,
1% C
lostri
um d
ifficil
e infe
ction
(cont
inued
)
R. Nasser et al.
148 J Neurosurg: Spine / Volume 13 / August 2010
TABL
E 1:
Lite
ratu
re re
view
of t
hora
colu
mba
r stu
dies
* (co
ntin
ued)
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pa
tients
Dura
tion o
f St
udy/F
UIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d†Ju
les-E
lysee
et al
., 20
04
retro
spec
tive r
eview
60
2 yrs
64
% in
ciden
ce
roen
tgen-
o gra
phic
pulm
onar
y co
mplic
ation
pulm
onar
y com
plica
tions
: 66%
effu
sion,
21%
infilt
rates
, 13%
parti
al or
comp
lete l
obar
colla
pse
Kallm
es et
al., 2
002
retro
spec
tive r
eview
4128
days
over
all, 4
.8%2.4
% S
taph
yloco
ccus
epid
erm
idis i
nfecti
on, 2
.4% pe
dicle
fractu
re
Kara
dimas
et al
., 20
08re
trosp
ectiv
e rev
iew16
31 y
rov
erall
, 23.
5%1.8
% di
ed, 1
.2%
PE,
1.2%
atele
ctasis
, 1.2
% po
stop h
emato
ma, 0
.6% pa
ralys
is of
diaph
ragm
, 2.5%
card
io-log
ical p
roble
ms, 0
.6% ce
rebr
al th
romb
osis,
1.8%
resid
ual p
soas
absc
ess,
1.2%
panc
reati
c abs
cess
, 0.6
% ce
rebe
llar a
bsce
ss, 1
.8% pu
lmon
ary i
nfecti
on, 9
% re
admi
tted t
o hos
pital
for f
urth
er su
rger
yKa
tonis
et al.
, 200
3re
trosp
ectiv
e rev
iew11
235
mos
over
all, 3
6.5%
10
.7% ha
rdwa
re fa
ilure
s, 4.5
% ju
nctio
nal p
roble
ms, 3
4.7%
prob
lems i
n ins
trume
nted s
egme
nts, 4
.5%
prob
lems i
n bala
nce
Koch
et al
., 200
7re
trosp
ectiv
e rev
iew68
takin
g co
rtico
-ste
roids
, 37
9 con
-tro
ls
2 yrs
corti
coste
roids
: ov
erall
, 4.4
%; c
on-
trols:
over
all,
3.4%
corti
coste
roids
: 2.9
% ra
diculo
path
ies, 1
.5% ve
rtebr
al fra
cture
; con
trols:
1% r
ib fra
cture
s, 0.
8% ra
diculo
pa-
thies
, 0.5%
hype
rtens
ive ep
isode
s, 0.
5% r
espir
atory
arre
st, 0.
3% P
E, 0.
3% ur
inary
reten
tion
Kuo e
t al.,
2004
re
trosp
ectiv
e rev
iew32
306 y
rsov
erall
in ci-
denc
e of
post o
p infe
c-tio
n, 0.9
%
posto
p wou
nd in
fectio
n: 1.1
5% of
pst d
ecom
pres
sion w
/ fixa
tion &
fusio
n, 0.
37%
of la
mine
ctomy
& di
scec
t-om
y, 4.4
% of
revis
ion fix
ation
w/ d
ecom
pres
sion,
0.33
% of
impla
nt re
mova
l
Kusli
ch et
al., 2
000
pros
pecti
ve m
ulti-
cente
r tria
l19
64 y
rsov
erall
, 15.
3%2.
6% in
comp
lete r
elief
or ex
acer
batio
n of le
g &/or
back
pain,
8.7%
requ
ired s
econ
dary
surg
ical p
roce
dure
, 3%
need
ed re
op du
e to p
seud
arth
rosis
, 5.6%
disc
dege
nera
tion o
r her
niated
nucle
us pu
lposu
s req
uiring
re
opKu
slich
et al
., 199
8pr
ospe
ctive
mult
i-ce
nter t
rial
947
2 yrs
ov
erall
, 22.
9%2%
majo
r com
plica
tions
, 8.2
% in
traop
(majo
r & m
inor),
9.5%
posto
p (ma
jor &
mino
r), 3.
8% du
ra re
lated
, 2.7
% ne
urolo
gical,
2.4%
supe
rinfec
tion,
1.5%
illeu
s, 1.2
% im
plant
migr
ation
(reo
p), 1.
5% im
plant
migr
a-tio
n (w/
o reo
p), 1.
4% ne
w ra
dicula
r pain
Kusli
ch et
al., 1
998
retro
spec
tive r
eview
118
33 m
osov
erall
, 27.8
%3.
4% du
ral te
ar, 2.
5% ne
rve r
oot in
jury,
7.5%
subo
ptima
l cag
e pos
ition,
2.5%
cage
retro
pulsi
on, 3
.4% ca
ge
subs
idenc
e, 1.7
% po
stlam
inecto
my ar
achn
oiditis
, 5.1%
pseu
darth
rosis
, 1.7%
death
canc
er &
accid
ent
Lapp
et al
., 200
1 re
trosp
ectiv
e rev
iew
4442
mos
over
all, 2
2%
12%
revis
ion pa
tients
and 2
2% pr
imar
y pati
ents
w/ m
ajor c
ompli
catio
nsLa
yton e
t al.,
2007
retro
spec
tive r
eview
552
2 yrs
over
all, 1
.8%1%
rib f
ractu
res,
0.15%
tran
sver
se pr
oces
s fra
cture
, 0.3%
new-
onse
t rad
iculop
athy,
0.15%
ceme
nt PE
, 0.1
5% ce
ntral
spina
l can
al co
mpro
mise
Leon
et al
., 200
5re
trosp
ectiv
e rev
iew
74
11 m
osov
erall
, 31%
DV
T in
31%
Linvil
le et
al., 1
999
retro
spec
tive r
eview
prim
ary:
18,
revis
ion
surg
ery:
26
6 mos
pr
imar
y: ov
erall
, 22
.2%
revi-
sion:
over
all,
22.9
%
prim
ary:
5.6%
ileus
, 5.6%
bacte
remi
a, 11
.1% de
ep w
ound
infec
tion;
revis
ion: 3
.8% ile
us, 3
.8% D
VT, 7
.7%
deep
wou
nd in
fectio
n, 3.
8% in
strum
enta
tion f
ailur
e, 3.
8% ne
urolo
gical
defic
it
(cont
inued
)
J Neurosurg: Spine / Volume 13 / August 2010
Complications literature review
149
TABL
E 1:
Lite
ratu
re re
view
of t
hora
colu
mba
r stu
dies
* (co
ntin
ued)
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pa
tients
Dura
tion o
f St
udy/F
UIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d†Lo
nstei
n et a
l., 19
99re
trosp
ectiv
e rev
iew87
5 3 y
rsov
erall
, 24.5
%
23%
late
-ons
et dis
comf
ort, 1
% ir
ritati
on of
nerv
e roo
t, 0.5%
scre
ws br
oke
Maz
da et
al., 2
009
pros
pecti
ve st
udy
7530
± 5
mos
over
all, 2
5.5%
1.3%
tran
sient
supe
rior m
esen
teric
arter
y syn
drom
e, 2.
6% de
ep w
ound
infec
tion,
14.6%
loss
of co
rrecti
on, 7
%
disab
ling p
ain
McL
ain et
al., 2
001
longit
udina
l pro
spec
-tiv
e stu
dy75
5 yrs
over
all, 3
4.7%
1.3%
inco
mplet
e cor
d inju
ry, 6.
7% ex
cess
ive he
morrh
age,
1.3%
wou
nd in
fectio
n, 4%
UTI
, 1.3%
decu
bitus
ulc
er, 1.
3% A
RDS,
5% ps
eudo
arth
rosis
, 11%
incid
ence
of sa
gitta
l coll
apse
, 2.7%
late
infec
tion
Moh
amad
et al
., 20
07re
trosp
ectiv
e rev
iew17
53 m
osov
erall
perio
p, 33
.1%
19.4%
pulm
onar
y iss
ues,
9.7%
wou
nd &
impla
nt inf
ectio
ns, 4
% ca
rdiov
ascu
lar co
mplic
ation
s, 4.6
% in
traop
ne
urolo
gical
chan
ges,
5.7%
misc
ellan
eous
comp
licati
ons,
3.4%
prob
lemati
c ins
trume
ntati
on
Möll
er et
al., 2
000
pros
pecti
ve ra
ndom
-ize
d stu
dy77
2 yrs
over
all, 2
9%
2.6%
L-5 r
oot in
jury w
/ per
mane
nt se
quela
e, 1.3
% pe
rman
ent b
lindn
ess i
n 1 ey
e
Oerte
l et a
l., 20
06re
trosp
ectiv
e rev
iew13
35.
6 yrs
over
all, 9
.8%6.
8% in
ciden
tal d
uroto
my, 1
.5% su
perfi
cial d
istur
banc
e of w
ound
heali
ng, 0
.75%
deep
wou
nd in
fectio
n, 0.7
5%
spon
dylod
iscitis
Okuy
ama e
t al.,
1999
retro
spec
tive r
eview
148
3 yrs
over
all, 2
1.4%
8% tr
ansie
nt ne
ural
palsy
, 4%
dura
l tear,
4% pa
rtial
scre
w mi
splac
emen
t, 2.7%
scre
w loo
senin
g, 0.7
% sc
rew
brea
kage
, 0.7%
loss
of co
rrecti
on, 1
.3% de
ep in
fectio
nPa
o et a
l., 20
09
pros
pecti
ve st
udy
6015
.7 mo
sov
erall
, 18.
3%8.
3% du
ral te
ar, 3.
3% w
rong
leve
l ope
ratio
n, 6.7
% tr
ansie
nt ne
uralg
iaPa
rk et
al., 2
008
retro
spec
tive r
eview
5630
days
over
all, 1
4.3%
duro
tomy (
5), D
VT (1
), re
spira
tory d
istre
ss (1
), na
usea
(1),
UTI (1
), ur
inary
reten
tion (
1), tr
ansie
nt ra
diculo
pathy
(1)
Pated
er et
al.,
2008
retro
spec
tive r
eview
361
7 yrs
over
all, 3
.1%2.4
% pu
lmon
ary e
mboli
, 0.4
8% ep
idura
l hem
atoma
s, 0.
24%
wou
nd he
matom
a
Patel
et al
., 200
7re
trosp
ectiv
e rev
iew84
36 m
osov
erall
, 36.
9%20
.2%
sign
ifican
t com
plica
tions
, 9.5%
incid
enta
l dur
otomy
/CSF
leak
age,
9.5%
genit
ourin
ary i
nfecti
on, 3
.6%
woun
dPa
til et
al., 2
007
retro
spec
tive r
eview
26,2
3312
days
over
all, 2
1.9%
6.7%
pulm
onar
y, 5.
9% po
stop h
emor
rhag
e/he
matom
a, 3%
thro
mboe
mboli
c (DV
T +
PE),
2.2%
urina
ry or
rena
l, 1.9
% ca
rdiac
, 1.6%
infe
ctiou
s, 0.6
% ne
urolo
gical
Pflug
mach
er et
al.,
2008
pros
pecti
ve ev
alu-
ation
652 y
rsov
erall
, 20%
12%
ceme
nt lea
kage
, 8%
verte
bral
fractu
re
Raffo
et al
., 200
6 re
trosp
ectiv
e cas
e se
ries
20
2.57
yrs
over
all, 3
5%
15%
new-
onse
t atri
al fib
rillati
on/ar
rhyth
mia
Raga
b et a
l., 20
03re
trosp
ectiv
e rev
iew11
87 y
rsov
erall
, 20%
8%
diso
rient
ation
& co
nfus
ion, 9
% du
ral te
ars,
3% w
ound
infec
tion
Rajar
aman
et al
., 19
99
retro
spec
tive r
eview
6012
mos
over
all, 3
8.3%
10
% sy
mpath
etic d
ysfu
nctio
n, 6.
6% va
scula
r injur
y, 5%
soma
tic ne
ural
injur
y & pr
olong
ed ile
us, 5
% se
xual
dysfu
nctio
n, 1.6
% D
VT, a
cute
panc
reati
tis, &
bowe
l injur
yRa
mper
saud
et al
., 20
06pr
ospe
ctive
obse
r-va
tiona
l stu
dy70
06 m
osov
erall
, 14%
8.3%
dura
l tear
s, 1.7
% sp
inal in
strum
enta
tion–
relat
ed ev
ents,
1.4%
bloo
d los
s exc
eedin
g 500
0 ml, 0
.6% an
-es
thes
ia/me
dical,
0.4%
verte
bral
arter
y inju
ry, 0.
4% ap
proa
ch-re
lated
even
ts, 0.
3% es
opha
geal/
phar
ynge
al inj
ury,
0.9%
misc
ellan
eous
Rhee
et al
., 200
3re
trosp
ectiv
e rev
iew42
24 m
osov
erall
, 59.6
%9.5
% w
ound
comp
licati
ons,
2.4%
PVC
, 2.4%
pleu
ral e
ffusio
n, 7%
othe
r med
ical, 7
% ne
urolo
gical,
17%
im
plant
relat
ed, 9
.5% lin
e rela
ted, 4
.8% m
iscell
aneo
us
(cont
inued
)
R. Nasser et al.
150 J Neurosurg: Spine / Volume 13 / August 2010
TABL
E 1:
Lite
ratu
re re
view
of t
hora
colu
mba
r stu
dies
* (co
ntin
ued)
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pa
tients
Dura
tion o
f St
udy/F
UIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d†Ri
nella
et al
., 200
4re
trosp
ectiv
e rev
iew67
7.8 yr
s ov
erall
, 15%
9% ps
euda
rthro
sis, 3
% tr
ansit
ion sy
ndro
me, 1
.5% co
mplet
e sym
ptoma
tic in
strum
enta
tion r
emov
al, 1.
5%
instru
ment
ation
dislo
dgem
ent
Schiz
as et
al.,
2008
pr
ospe
ctive
coho
rt27
02 y
rsov
erall
, 2.9
%2.
2% sy
mptom
atic P
E, 0.
7% po
stop h
emato
mas
Shaik
h et a
l., 20
03
retro
spec
tive r
eview
106
75 m
insov
erall
, 11%
4% du
ral te
ar in
4 pa
tients
, 6%
redo
disc
ectom
y in 6
patie
nts, 1
% ro
ot sle
eve t
ear
Sing
hal e
t al.,
2002
pros
pecti
ve st
udy
122
4 hrs
over
all, 4
.9%
1.6%
dura
l tear
s, 3.
3% an
esth
etic s
ide ef
fects
Skag
gs et
al.,
2000
retro
spec
tive s
tudy
214
55 m
osov
erall
, 3.9
%0.
5% ar
terial
injur
y, 1%
infe
ction
, 0.5%
sacr
oiliac
joint
pene
tratio
n, 1.4
% co
ntinu
ed pa
in, 0.
5% nu
mbne
ss
Suk e
t al.,
2001
retro
spec
tive r
eview
462
2 yrs
over
all, 2
3.5%
10.4%
scre
w ma
lposit
ions,
0.8%
neur
ologic
al co
mplic
ation
s, 2.4
% in
traop
pedic
le fra
cture
s, 7.8
% sc
rew
loose
ned,
1.9%
posto
p infe
ction
s, 0.
2% pn
eumo
thor
axSw
eet e
t al.,
2001
pros
pecti
ve ca
se
serie
s90
2 yrs
over
all, 7
.5%5.
5% ps
euda
rthro
sis, 1
% in
fectio
n rate
, 1%
scre
w pu
ll-bac
k
Taka
hash
i et a
l., 20
02
retro
spec
tive r
eview
584.5
yrs
over
all, 2
9%va
riety,
inclu
ding 1
.7% sy
mptom
atic p
seud
oarth
rosis
, 1.7%
late
-ons
et de
ep in
fectio
n, 1.7
% ho
ok di
slodg
emen
t, 3.
4% tr
ansv
erse
trac
tion d
evice
brea
kage
, 1.7%
late
-ons
et de
ep in
fectio
n Th
uet e
t al.,
2005
retro
spec
tive r
eview
4310
1 mo
0.77%
posto
p ne
urolo
gical
defic
it
0.19%
glob
al, 0.
058%
nerv
e roo
t defi
cits
Tsuc
hiya e
t al.,
2006
retro
spec
tive r
eview
676 y
rs
over
all, 2
4%6%
iliac
scre
w ba
ck-o
ut, 10
% ili
ac sc
rew
brea
kage
, 8%
nonu
nion a
t L5–
S1
Voos
et al
., 200
1 re
trosp
ectiv
e rev
iew27
21 m
osov
erall
, 34%
11
% ps
euda
rthro
sis, 1
9% ha
rdwa
re fa
ilure
s, 4%
tran
sient
neur
ologic
al de
ficit
Weis
et al
., 199
7re
trosp
ectiv
e rev
iew98
6 yrs
over
all, 2
6.5%
1%
majo
r com
plica
tions
(pelv
ic DV
T), 2
5.5%
mino
r com
plica
tions
Zdeb
lick e
t al.,
2000
pros
pecti
ve st
udy
503 m
osov
erall
, 24%
20%
comp
licati
on ra
te in
lapar
osco
pic gr
oup:
posto
p disc
hern
iation
(1),
urete
r injur
y (1),
iliac
vein
lacer
ation
(1)
, tran
sient
retro
grad
e ejac
ulatio
n (1),
DVT
(1);
4% co
mplic
ation
rate
in op
en gr
oup:
ileus
(1)
Zhan
g et a
l., 20
05
retro
spec
tive r
eview
29
872
hrs
posto
p FU
over
all, 1
2.32
%pu
lmon
ary c
ompli
catio
ns: d
yspn
ea 2%
, hyd
roth
orax
1.3%
, pne
umoth
orax
1%, p
neum
onia
1%; 5
.22%
patie
nts
w/ no
rmal
PFTs
; 7.10
% in
patie
nts w
/ abn
orma
l PFT
s
Zigle
r et a
l., 20
07pr
ospe
ctive
, ra
ndom
ized
multic
enter
268
24 m
osov
erall
, 1.8
6%re
trogr
ade e
jacula
tion i
n 2 pa
tients
in in
vesti
gatio
nal g
roup
, DVT
after
surg
ery i
n 2 pa
tients
in in
vesti
gatio
nal
grou
p & 1
patie
nt in
contr
ols
* AC
F = a
nterio
r cer
vical
fusio
n; an
t = an
terior
; ARD
S = a
cute
resp
irator
y dist
ress
synd
rome
; CHF
= co
nges
tive h
eart
failu
re; C
SJD
= clin
ically
sign
ifican
t juxta
fusio
nal d
iseas
e; DM
= dia
betes
mell
itus;
DVT
= dee
p ven
ous t
hrom
bosis
; FU
= foll
ow-u
p; ID
DM =
insuli
n-de
pend
ent D
M; M
I = m
yoca
rdial
infa
rctio
n; NI
DDM
= non
–insu
lin-d
epen
dent
DM; P
E = p
ulmon
ary e
mboli
sm; P
FT =
pulm
onar
y fun
ction
tes
t; pst
= po
sterio
r; PV
C =
paro
xysm
al ve
ntricu
lar co
ntrac
tions
; UTI
= ur
inary
trac
t infe
ction
.†
Who
le nu
mber
s in p
aren
thes
es re
pres
ent th
e num
ber o
f cas
es.
J Neurosurg: Spine / Volume 13 / August 2010
Complications literature review
151
TABL
E 2:
Lite
ratu
re re
view
of c
ervic
al st
udie
s
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pati
ents
Dura
tion o
f St
udy/F
UIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d*
Abum
i et a
l., 20
00re
trosp
ectiv
e rev
iew18
02 y
rsov
erall
, 3.7%
1.7%
nerv
e roo
t injur
y, 0.
5% ve
rtebr
al ar
tery i
njury,
1% in
fecti
on, 0
.5% ps
euda
rthro
sisBa
rnes
et al
., 200
2re
trosp
ectiv
e rev
iew77
15.3
3 mos
over
all, 6
.5%1.3
% an
t wou
nd, 1
.3% w
ound
infec
tion,
2.6%
ant s
crew
back
-out
&/or
brea
kage
, 1.3%
die
d of u
nrela
ted ca
uses
Ca
o et a
l., 20
08re
trosp
ectiv
e rev
iew83
3 yrs
9 mo
sov
erall
, 14.4
%1.2
% in
terna
l fixa
tor lo
osen
ess &
esop
hagu
s fistu
la, 4.
8% tit
anium
mes
h sub
siden
ce, 6
%
tempo
rary
recu
rrent
laryn
geal
nerv
e inju
ry, 2.
4% su
perfi
cial in
fectio
nCl
oyd e
t al.,
2008
retro
spec
tive r
eview
58 pa
tients
≥6
5 yrs
, 58
patie
nts
<65 y
rs
contr
ols: 3
4.2
mos,
elder
ly:
32.3
mos
≥65 y
rs: ov
erall
, 48.
3%;
<65 y
rs: ov
erall
, 39
.6%; b
oth gr
oups
: ov
erall
, 44%
≥65 y
ears:
12.1%
pneu
monia
, 10.
3% re
spira
tory,
1.7%
MI, 1
.7% ne
urolo
gical
defic
it, 1.7
%
intra
cran
ial he
morrh
age,
12.1%
dysp
hagia
, 5.2
% co
nfus
ion, 5
.2%
arrh
ythmi
a, 3.
4%
dysp
honia
, 6.9
% ot
her;
<65 y
ears:
5.2%
pneu
monia
, 3.4%
resp
irator
y dist
ress
, 6.9
%
woun
d infe
ction
, 1.7%
MI, 1
.7% ne
urolo
gical
defic
it, 1.7
% m
ening
itis, 6
.9%
dysp
hagia
, 6.
9% co
nfus
ion, 1
.7% U
TI, 6
.9%
othe
rDa
ubs,
2005
retro
spec
tive r
eview
2328
mos
over
all, 5
1.6%
30%
cata
strop
hic fa
ilure
of fix
ation
, 4.3%
hema
toma,
8.7%
seve
re dy
spha
gia, 4
.3% re
quir-
ing te
mpor
ary g
astri
c fee
ding t
ube,
4.3%
C-5
nerv
e pals
yDe
en et
al., 2
006
pros
pecti
ve st
udy
100
16.7
mos
over
all, 1
6%4%
radic
ulopa
thy, 4
% in
fecti
on &
othe
r wou
nd-h
ealin
g pro
blems
, 2%
scre
w ma
lposit
ion,
1% lo
ss of
align
ment,
1% C
SF le
akag
e, 2%
pseu
darth
rosis
, 2%
scre
w br
eaka
geEp
stein
2003
retro
spec
tive
analy
sis42
34 m
osov
erall
, 16.7
%9.5
% po
stop p
late-
or gr
aft-r
elated
comp
licati
ons,
2.4%
delay
ed ili
ac cr
est s
trut f
ractu
re,
4.8%
pseu
darth
rosis
Haid
et al.
, 200
1re
trosp
ectiv
e rev
iew75
2.4 yr
sov
erall
, 12%
4% ps
euda
rthro
sis, 2
.7% w
ound
infe
ction
s, 5.
3% tr
ansie
nt su
bocc
ipita
l hyp
esth
esia
Houte
n & C
oope
r, 20
03re
trosp
ectiv
e rev
iew38
30.2
mos
over
all, 1
5.7%
comp
licati
ons i
nclud
ed pn
eumo
nia (1
), MI
(1),
trans
ient C
-5 ne
rve r
oot p
alsy (
1), po
stop
uppe
r extr
emity
pain
(1), s
uper
ficial
wou
nd in
fectio
n (1),
& H
IV-re
lated
death
(1)
Lowe
ry &
Mc-
Dono
ugh,
1998
retro
spec
tive r
eview
109
43 m
osov
erall
, 35%
35%
hard
ware
failu
re
Mac
dona
ld et
al.,
1997
re
trosp
ectiv
e rev
iew36
31 ±
20 m
osov
erall
, 51%
3% op
mor
tality
rate,
6% de
ath 2
mos p
ostop
erati
vely,
8% ea
rly gr
aft d
isplac
emen
t, 6%
tra
nsien
t dys
phag
ia, 8%
CSF
leak
age,
6% M
I, 3%
late
graf
t fra
cture
, 3%
tran
sient
wors
ening
of m
yelop
athy,
8% ra
diculo
pathy
Majd
et al
., 199
9 co
hort
study
3432
mos
over
all, 1
1.6%
2.9%
pseu
darth
rosis
, 2.9
% ex
trude
d cag
e, 2.
9% ca
ge in
kyph
osis,
2.9%
radic
ulopa
thyM
ayr e
t al.,
2002
retro
spec
tive r
eview
261
25.7
mos
over
all, 3
8.4%
0.8%
tran
sient
unila
t upp
er-e
xtrem
ity w
eakn
ess,
13.4%
tran
sient
dysp
hagia
, 2.7%
pe
rman
ent d
ysph
agia,
13.4%
tran
sient
hoar
sene
ss, 2
.7% pe
rman
ent h
oars
enes
s, 5.4
%
radio
logica
l evid
ence
of ha
rdwa
re fa
ilure
Mum
mane
ni et
al.,
2002
retro
spec
tive r
eview
326 m
osov
erall
, 12.4
%3.1
% du
ral te
ar, 3.
1% m
alpos
itione
d scr
ew, 6
.2%
wou
nd in
fectio
n
Naka
se et
al., 2
006
retro
spec
tive r
eview
2654
.3 m
osov
erall
, 11.5
%3.
8% dy
spne
a, 7.7
% C
SF le
akag
e Ra
mzi e
t al.,
2008
pr
ospe
ctive
long
itudi-
nal s
tudy
4044
mos
over
all, 1
7.5%
5% dy
spha
gia, 5
% vo
cal c
ord p
ares
is, 5%
wou
nd in
fecti
on, 2
.5% H
orne
r syn
drom
e
Reind
l et a
l., 20
06re
trosp
ectiv
e rev
iew41
14.6
mos
over
all, 2
6.8%
19.5%
dysp
hagia
or od
ynop
hagia
, 7.3%
supe
rficia
l infec
tion
Riew
et al
., 199
9re
trosp
ectiv
e rev
iew18
2.7 yr
sov
erall
, 61%
50%
graf
t-rela
ted co
mplic
ation
s, 11
% re
spira
tory d
istre
ss, 5
.6% du
ral te
ar, 5.
6% tr
ansie
nt dy
spha
gia
(cont
inued
)
R. Nasser et al.
152 J Neurosurg: Spine / Volume 13 / August 2010
posterior procedures. This trend did not reach statistical significance (p = 0.09).
The articles were separately reviewed to determine whether a clear consensus on what constituted an opera-tive complication in spine surgery would emerge. There was no consensus with regard to a definition of “compli-cation” among the different articles. Assessed complica-tion types are reviewed in Tables 1 and 2.
Some perioperative complications were more com-mon in each spinal segment reviewed. Thoracolumbar complications were more often related to the procedure performed, with routine reports of pseudarthrosis and hardware failures. Commonly reported thoracolumbar complications also included postoperative radiculopa-thies, wound infections, and urinary tract infections. Cer-vical complications were more often approach related, including dysphagia and dysphonia. Other common cer-vical complications included postoperative hematoma, C-5 nerve root palsy, increase in axial neck pain, and hardware failures.
Although our review was not specifically restricted to adults, articles on pediatric complications were rare. Only 5 articles focused on pediatric spine procedures (4.7%). Similarly, the majority of articles focused on complica-tions of fusion procedures, with limited recent reports on decompression procedures alone.
DiscussionThe standardization of outcomes reporting will ulti-
mately aid in the identification, management, and avoid-ance of perioperative complications and adverse events. Benzel et al.8 surveyed spinal surgery authors on the subject of complications. Most respondents reported that the quality of both medical practices and the general lit-erature would be improved with a precise definition of perioperative complications. The need for better com-plication incidence reporting is further magnified by the incorporation of clinical outcomes assessments by man-aged care organizations and other payers. These organi-zations are attempting to quantify provider performance by using measurable factors such as complication rates. A poor understanding of complication incidence provides a suboptimal foundation for performance reporting. The successful implementation of reliable clinical outcomes reporting relies on equally reliable complications report-ing. Effective comparisons across different centers and various procedures and within a given center at different time points requires a standardized method of reporting complications.75 There is no consensus in the literature regarding the appropriate assessment of complication in-cidence in spine surgery.
Complication Incidence: Overall ComplicationsThe overall incidence of spinal surgery complications
for the present entire patient cohort was 16.4%. When an-alyzed by the anatomical region treated, the average com-plications incidence was 8.9% for cervical procedures, compared with 17.8% incidence for thoracolumbar pro-cedures. There were significantly more complications in thoracolumbar series than in cervical series (p < 0.0001). TA
BLE
2: L
itera
ture
revi
ew o
f cer
vical
stud
ies (
cont
inue
d)
Auth
ors &
Yea
rSt
udy T
ype
No. o
f Pati
ents
Dura
tion o
f Stu
dy/
FUIn
ciden
ce of
Co
mplic
ation
sCo
mplic
ation
Type
s Ass
esse
d*Ro
mano
et al
., 19
97
retro
spec
tive c
ohor
t stu
dy10
,416
2 yrs
over
all, 6
.7%1.8
% no
ninfec
tious
surg
ical c
ompli
catio
ns, 1
.8% in
fectio
us co
mplic
ation
s, 4.0
% ot
her
medic
al co
mplic
ation
s, 0.
35%
unpla
nned
reop
, 0.13
% de
ath
Sevk
i et a
l., 20
04
retro
spec
tive r
eview
2630
mos
over
all, 3
8.4%
11
.5% tr
ansie
nt C-
5 ner
ve ro
ot inj
ury,
3.8%
early
deep
pst in
fectio
nSt
ulik e
t al.,
2007
pros
pecti
ve, m
ulti-
cente
r ran
domi
zed
contr
olled
stud
y
132
6 mos
over
all, 3
%3%
surg
ical h
ardw
are c
ompli
catio
ns
Thalg
ott e
t al.,
2003
retro
spec
tive r
eview
2624
–64 m
osov
erall
, 22.
9%7.7
% sc
rew
back
-out,
3.8%
temp
orar
y par
alysis
, 3.8%
scre
w br
eaka
ge, 3
.8% pl
ate/
scre
w se
ttling
, 3.8%
sero
maW
ada e
t al.,
2001
retro
spec
tive r
eview
4710
yrs
over
all, 2
5.5%
co
rpec
tomy g
roup
: 15%
axia
l pain
, 30%
graf
t com
plica
tions
; lami
nopla
sty gr
oup:
40%
ax
ial pa
in, 16
% tr
ansie
nt C-
5 roo
t pals
yW
ang e
t al.,
2001
retro
spec
tive r
eview
593.
2 yrs
over
all, 2
7.1%
23.7%
pseu
darth
rosis
, 1.7%
supe
rficia
l wou
nd in
fectio
n, 1.7
% tr
ansie
nt lar
ynge
al ne
rve
palsy
Wan
g et a
l., 20
07
retro
spec
tive r
eview
932,0
09
(pop
ulatio
n-ba
sed d
ata)
9 day
sov
erall
, 3.9
3%
highe
st inc
idenc
e of c
ompli
catio
ns oc
curre
d in p
atien
ts w/
prim
ary d
iagno
sis of
cerv
ical
spon
dylos
is w/
mye
lopath
y (6.
5%),
most
prev
alent
comp
licati
on w
as ca
rdiac
(1.6
9%)
* W
hole
numb
ers i
n par
enth
eses
repr
esen
t the n
umbe
r of c
ases
.
J Neurosurg: Spine / Volume 13 / August 2010
Complications literature review
153
However, there was significant variability in the defini-tion of a complication and in complications reporting. The range of reported complication incidences was large: cervical incidences ranged from 3% to 61% and thora-columbar incidences ranged from < 1% to approximately 70%.
The duration of follow-up correlated with complica-tion incidence. As expected, the longer periods of follow-up correlated with an increased incidence of operative complications (Fig. 5). Nevertheless, some reports with very short follow-ups documented high complication incidences. Carreon et al.18 reviewed posterior lumbar arthrodesis procedures in the elderly and reported an ap-proximately 70% complication incidence with a follow-up limited to fewer than 10 days.
Definition of an Operative ComplicationThere was no consensus in the reviewed articles with
regard to the definition of an operative complication in spine surgery. Similarly, there was little agreement among the articles as to the relevance of medical complications, particularly in retrospective reports. The most basic grad-ing scheme divided complications into major and minor
or present and absent. There was no general agreement in the reviewed articles as to the definition of complication severity.
Rampersaud et al.82 presented a complication grading system based on the clinical effects of each event and the influence these effects had on the duration of the hospital stay. A complication was defined as “a state, directly or indirectly resulting from a surgical operation that altered the anticipated recovery of the patient.” Complications were further graded as minor, moderate, or major. Minor complications required little (1 day) or no increase in the duration of stay with minimal or no additional treatment required. Moderate complications warranted treatment, increased the duration of stay by 2–7 days, and/or cre-ated no long-term sequelae (≤ 6 months). Major compli-cations required significant levels of treatment, increased the duration of stay by > 7 days, and/or created long-term sequelae (≥ 6 months). In addition, these authors described an adverse event as any unexpected or unde-sirable incident happening as a result of surgery, either directly or indirectly. Thus, a complication can occur as a result of an adverse event, but it is also possible for an adverse event to happen without an associated compli-cation. Rampersaud et al. found that adverse events oc-curred in 14% of the spinal surgeries evaluated, and most
Fig. 1. Bar graph demonstrating a higher complication rate with tho-racolumbar spine surgeries. The cervical surgery complication rate was 8.86%, and the thoracolumbar complication rate was 17.80%. The tho-racolumbar complications group had a higher complication incidence, with an OR of 2.23 (95% CI 2.08–2.38, p < 0.0001).
Fig. 2. Bar graph demonstrating a higher incidence of complica-tions with prospectively designed studies (19.94%). Retrospective stud-ies had a complication rate of 16.10%. The prospective complications group had a higher complication incidence, with an OR of 1.30 (95% CI 1.22–1.38, p < 0.0001).
Fig. 3. Bar graph showing a joint analysis of complication rates for cervical prospective (10.13%), cervical retrospective (8.83%), thora-columbar (TL) prospective (20.38%), and thoracolumbar retrospective (17.50%). The prospective complication group had higher complication incidence, with an OR of 1.21 (95% CI 1.13–1.28).
Fig. 4. Graph demonstrating a logistic fit that showed no statistical significance regarding the year of the study and complication rate.
R. Nasser et al.
154 J Neurosurg: Spine / Volume 13 / August 2010
of these adverse events (76.5%) were not associated with a complication.
Relevance of Study DesignIt is assumed that retrospective analyses are not as re-
liable as prospective studies in assessing the complication incidence and overall outcomes in surgical treatments.105 Similarly, surgeon self-assessments of operative outcomes and complications are less reliable than independent, pro-spective assessments.75 The correlation between surgeon and patient opinions of operative outcomes is poor.36,65
Our results indicate that retrospective reviews under-estimate the incidence of complications in spine surgery. Overall, prospective studies reported a higher incidence of complications (19.9%) than did retrospective studies (16.1%, p < 0.0001, OR 1.3). Study design independently predicted the complication incidence in the entire cohort and in thoracolumbar procedures in isolation (prospective 20.4%, retrospective 17.5%, p < 0.0001; Figs. 2 and 3).
Retrospective reviews add considerable risks of bias in results reporting. Recall bias poses a significant risk to studies utilizing self-reported data.6 Differential recall of complication occurrence and overall patient outcomes can alter results as well.40 Prospective studies seek to lim-it these sources of bias by reducing recall and selection bias. Previous assessments of the spine surgery literature have shown that differential recall bias limits the validity of studies relying on patient recall of preoperative clinical status.77
Previous reviews of the general surgery literature do not reveal a relationship between study methodology, and adverse event and complication incidence. Marang-van de Mheen et al.61 reviewed the general surgery literature, concentrating on hospital deaths and adverse outcomes to determine whether study design affected outcomes re-porting. These authors found no significant difference in their patient cohorts and concluded that study methodol-ogy does not significantly contribute to adverse outcomes reporting. To our knowledge, theirs is the first attempt at a larger systematic review of the impact of study design on adverse outcomes reporting in the spine surgery lit-erature.
Sources of BiasOur review is incomplete in that to maintain a man-
ageable sample size of articles, the study was restricted by certain inclusion criteria. Articles not indexed within the PubMed system were not assessed. Articles outside an arbitrary 16-year time frame were not assessed. Smaller series were also omitted. While our article selection prob-ably offers adequate representation of the overall spine surgery canon, this assumption is impossible to confirm. Incorporating non–English language articles, referencing reports not indexed within the MEDLINE system, in-cluding case reports and smaller series, or broadening the study timeline could alter the final results.
Some of the retrospective articles we considered are large reviews. The review of lumbar spine complications by Deyo et al.29 featured over 18,000 patients, and the retrospective review by Patil et al.76 included more than 26,000 patients.The large patient numbers in these series may bias the overall results through overweighing certain aspects of the review. But any analysis seeking to sum-marize the spine surgery literature must incorporate these studies, regardless of the potential for bias of the results through uneven sample sizes. We included articles with a variety of pathologies, including fractures, neoplasms, and degenerative conditions. We increased the scope of the study by not restricting our analysis to particular age groups, specific diagnoses, or distinct surgical procedures but we introduced an additional source of bias by includ-ing a wide array of disease processes.
ConclusionsThis systematic review of the spine surgery literature
indicates that retrospective studies document a signifi-cantly lower incidence of complications than prospective trials. Complications were reported more often in thora-columbar procedures than in cervical procedures. Longer patient follow-ups correlated with a higher complication incidence. Confirmation of anticipated underreporting of complication incidence in retrospective reviews may con-tribute to future study designs.
Disclosure
The authors report no conflict of interest concerning the mate-rials or methods used in this study or the findings specified in this paper.
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Manuscript submitted April 24, 2009.Accepted March 22, 2010Address correspondence to: John K. Ratliff, M.D., Department of
Neurosurgery, Thomas Jefferson University, 909 Walnut 2nd Floor, Philadelphia, Pennsylvania 19107. email: [email protected].