complications in spine surgery - semantic scholar...retrospective cervical and thoracolumbar spine...

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.

http://thejns.org/doi/full/10.3171/2009.11.SPINE09758

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.


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

)



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.


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

)



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.


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.



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.


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

.



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.


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].

complications in spine surgery - semantic scholar...retrospective cervical and thoracolumbar spine...

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