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Cochrane Database of Systematic Reviews

Spinal fixation surgery for acute traumatic spinal cord injury


(Review)
Bagnall AM, Jones L, Duffy S, Riemsma RP

Bagnall AM, Jones L, Duffy S, Riemsma RP.


Spinal fixation surgery for acute traumatic spinal cord injury.
Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD004725.
DOI: 10.1002/14651858.CD004725.pub2.

www.cochranelibrary.com

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
PLAIN LANGUAGE SUMMARY .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
RESULTS . . . . . . . . . .
DISCUSSION . . . . . . . .
AUTHORS CONCLUSIONS . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
CHARACTERISTICS OF STUDIES
DATA AND ANALYSES . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
INDEX TERMS
. . . . . . .

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Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Spinal fixation surgery for acute traumatic spinal cord injury


Anne-Marie Bagnall1 , Lisa Jones2 , Steven Duffy3 , Robert P Riemsma3
1 Faculty of Health, Leeds Metropolitan University, Leeds, UK. 2 Centre for Public Health, Liverpool John Moores University, Liverpool,

UK. 3 NHS Centre for Reviews and Dissemination, University of York, York, UK
Contact address: Anne-Marie Bagnall, Faculty of Health, Leeds Metropolitan University, Calverley Street, Leeds, LS1 3HE, UK.
A.Bagnall@leedsmet.ac.uk.
Editorial group: Cochrane Injuries Group.
Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.
Review content assessed as up-to-date: 9 October 2007.
Citation: Bagnall AM, Jones L, Duffy S, Riemsma RP. Spinal fixation surgery for acute traumatic spinal cord injury. Cochrane Database
of Systematic Reviews 2008, Issue 1. Art. No.: CD004725. DOI: 10.1002/14651858.CD004725.pub2.
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
If the spine is unstable following traumatic spinal cord injury (SCI), surgical fusion and bracing may be necessary to obtain vertical
stability and prevent re-injury of the spinal cord from repeated movement of the unstable bony elements. It has been suggested that
this spinal fixation surgery may promote early rehabilitation and mobilisation.
Objectives
To answer the question: is there a difference in functional outcome and other commonly measured outcomes between people who have
a spinal cord injury and have had spinal fixation surgery and those who have not?
Search methods
The following databases were searched: AMED, CCTR, CINAHL, DARE, EMBASE, HEED, HMIC, MEDLINE, NRR, NHS EED.
Searches were updated in May 2003 and MEDLINE was searched again in May 2007. The reference lists of retrieved articles were
checked.
Selection criteria
Randomised controlled trials and controlled trials that compared surgical spinal fixation, with or without decompression, to any other
treatment, in patients with a traumatic SCI.
Data collection and analysis
Two reviewers independently selected studies. One reviewer assessed the quality of the studies and extracted data.
Main results
No randomised controlled trials or controlled trials were identified that compared surgical spinal fixation surgery to other treatments
in patients with a traumatic SCI. All of the studies identified were retrospective observational studies and of poor quality.
Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Authors conclusions
The current evidence does not enable conclusions to be drawn about the benefits or harms of spinal fixation surgery in patients with
traumatic SCI. Well-designed, prospective experimental studies with appropriately matched controls are needed.

PLAIN LANGUAGE SUMMARY


The benefits and harms of spinal fixation surgery for people with spinal cord injury due to trauma are not known at the moment
This review found no controlled trials of spinal fixation surgery for the patient group. The quality of the existing evidence is too poor
to include in the review, as it is likely to be unreliable. Good quality controlled trials are needed to answer this question.

BACKGROUND
There is no accepted figure for the incidence of new cases of acute
spinal cord injury (SCI) globally; estimates range from 10 to 83
cases per million population annually (Wyndaele 2006). It is estimated that between 500 and 700 people sustain a traumatic SCI
in the UK each year (Harrison 2000), and that there are approximately 10,000 new cases per year in the USA (McDonald 2002).
SCI can occur at any age. The effects are usually permanent and
currently there is no cure (Smith 1999). The modal age of SCI
is 19 years, most people with SCI then live a relatively normal
lifespan, so the lifetime cost of care may be quite high. The average lifetime cost of treating a person with SCI has been estimated at between US$500,000 and US$2 million, depending on
the extent and location of injury (McDonald 2002). The most
common mechanism of injury is a sudden unexpected impact or
deceleration (e.g. road traffic injury, domestic falls). Further neurological deterioration, resulting from lesion extension after the
initial injury, can occur naturally in about 5% of cases (Harrison
2000) and complications associated with the systemic effects of
SCI can lead to respiratory compromise. Significant delays and
complications - sometimes leading to admission to an intensive
therapy unit (ITU) can also arise as a result of inappropriate or
poorly informed management.
If the spine is unstable following injury, surgical fusion and bracing
may be necessary to obtain vertical stability and prevent re-injury
of the spinal cord from repeated movement of the unstable bony
elements (Geisler 1988). It has been suggested that spinal fixation
surgery may enable early rehabilitation and mobilisation. There
does not seem to be an accepted protocol with regard to what type
of surgery is used: whether surgical stabilisation or surgical decompression are required, and what type of approach, instrumentation
and procedure should be chosen. In some cases the procedure in-

volves posterior decompression and fusion with a bone graft and


with hardware consisting of wires or rods.
Different techniques are used for cervical spine surgery and for
thoracolumbar spine surgery (Donovan 1994). In the cervical region, several stabilising options exist: the soft cervical collar, the
Philadelphia collar, the sternal-occipital-mandibular immobiliser
(SOMI), Yale types of cervical-post brace, the halo vest, and the
thermoplastic Minerva body jacket (Amar 1999). The procedure
may vary between surgeons; for example, surgeons in a specialist
spinal injuries unit (SIU) may be more likely to use bone grafts.
Surgical reduction and stabilisation of the spine at the immediate/early stage is done to prevent secondary spinal cord injury
(McDonald 2002), but can cause further oedema at the lesion site
with a resulting extension of ischaemia. Early internal stabilisation surgery is reported to have substantial pragmatic advantages
in later rehabilitation phases compared with external (halo) stabilisation devices alone (McDonald 2002). Indications for both
surgical stabilisation and surgical decompression are subjective.
Arguments for spinal fixation, or stabilisation, surgery tend to focus on perceived advantages, such as shorter hospital stays, assurance of stability, correction of deformity and enhancement of
neurological recovery. The strength of the case for spinal fixation
surgery can depend on factors such as the patients general medical
condition, spinal instability, deformity and completeness and level
of the lesion (Donovan 1994). Benefits of stabilisation surgery have
been agreed in the UK (by the British Association of Spinal Cord
Injuries Specialists, the British Association of Spinal Surgeons and
the British Cervical Spine Society) to be protection of the neural
tissues, reduction of pain, easier patient handling, earlier mobilisation within physiological restrictions, reduction of respiratory
complications and reduction in late deformity with better posture
and balance (British Orthopaedic).

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

On the other hand, surgery is considered by some to potentially


lead to hypoxia, hypotension, further mechanical damage and
post-operative complications such as bleeding, chest or urinary
infection and infection at the wound site (El Masri 2006).
A systematic review (Bagnall 2003) was commissioned by the
Health Technology Assessment Programme on the effectiveness
and cost-effectiveness of acute hospital-based services for spinal
cord injuries. The HTA review aimed to answer five research questions. One of those questions, the effectiveness and cost-effectiveness of spinal fixation surgery, will be addressed in this review in
greater detail.

OBJECTIVES
The objective of this review is to answer the following research
questions:
1. Is there a difference in rate or completeness of neurological
recovery between those who have had spinal fixation surgery and
those who have not?
2. Does spinal fixation surgery have an effect on time to
mobilisation, acute recovery from trauma, pain, posture, spinal
deformity, surgical complications, post traumatic syrinx and
other generally measured outcomes?

Types of outcome measures


The following outcome measures were eligible for inclusion in the
review:
Neurological improvement.
Functional ability.
Mobility.
Posture.
Activities of daily living.
Discharge venue and associated costs.
Time to mobilisation.
Acute recovery from trauma.
Pain.
Psychological and social outcomes (including employment).
Revisions/removals.
Infections (especially methicillin-resistant staphylococcus
aureus (MRSA)).
Incidence of secondary complications (such as pressure
sores).
Other adverse events e.g. spinal deformity, post traumatic
syrinx, time spent in intensive care, on ventilation etc.
Death.

Search methods for identification of studies

Published and unpublished randomised or non-randomised controlled trials (RCTs or CCTs).

The search strategy was devised to find papers about spinal fixation surgery for spinal cord injuries. This strategy combined terms
for spinal cord injury with terms for fixation and fusion. The
strategy also used specific search terms for spinal cord surgery,
but not broader search terms for spinal surgery in order to narrow
the search. The terms used in the search strategy were identified
through discussion with the research team involved in the HTA
review, by scanning background literature and by browsing the
MEDLINE thesaurus (MeSH).
Full details of the search strategies are available from the authors
and from Bagnall 2003 in electronic format.
Searches were conducted for the HTA review in October 2001.
The searches were updated for this Cochrane review in May 2003
and the MEDLINE search was updated in May 2007.

Types of participants

Electronic searches

People of any age with a complete or partial interruption of spinal


cord function resulting from trauma.

The following databases were searched:


Allied and Complementary Medicine (AMED, to May
2003),
Cochrane Controlled Trials Register (CCTR, to May
2003),
Cumulative Index to Nursing and Allied Health Literature
(CINAHL, to May 2003),
Database of Abstracts of Reviews of Effectiveness (DARE,
to May 2003),
EMBASE (to May 2003),

METHODS

Criteria for considering studies for this review

Types of studies

Types of interventions
Surgical spinal fixation (with or without surgical decompression)
compared to any other treatment. Studies which compared different types of surgical spinal fixation were not included. Studies
which included postoperative external bracing were eligible for inclusion in the review.

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Health Economic Evaluations Databases (HEED, to May


2003),
Health Management Information Consortium (HMIC, to
May 2003),
MEDLINE (to May 2007),
National Research Register (NRR, to May 2003),
NHS Economic Evaluation Database (NHS EED, to May
2003).
In addition, the following searches were also carried out on
the Internet using OMNI (http://omni.ac.uk), Copernic (http:
//www.copernic.com/), Alta Vista (http://www.altavista.com/)
and Google (http://www.google.com/). Specialist spinal cord injury and spinal injury related web sites were searched, specifically: Spinal Injuries Association (http://www.spinal.co.uk/), the
British Association of Spinal Cord Injury Specialists (http://
www.bascis.pwp.blueyonder.co.uk/) and the National Spinal Cord
Injury Association (http://www.spinalcord.org/).
Searching other resources
The reference lists of all retrieved studies were also scanned for
additional studies.

Data collection and analysis


Two authors independently screened all study citations for inclusion. Any discrepancies were resolved by discussion with reference
to the original papers and, if necessary, by discussion with a third
reviewer. As no studies were found, there was no data to review.
It was intended to extract data onto forms developed for different
study designs on a Microsoft Access database. One reviewer was
to have extracted the data and a second to check the forms for
accuracy. Disagreements were to be resolved by discussion or, when
necessary, through discussion with a third reviewer.
The quality of studies that were included were to be assessed according to established criteria (NHS CRD 2001). Briefly, these
are as follows:
for RCTs, method of randomisation, method of allocation
concealment, blinding, handling of withdrawals, similarity of
groups at baseline, specified eligibility criteria, presentation of
results;
for non-randomised controlled studies, as above but
without the randomisation and allocation concealment
questions.
Quality assessment was to be carried out by one reviewer on to
predefined and piloted forms on a Microsoft Access database, and
checked by the second reviewer for accuracy. Any disagreements
were to be resolved by discussion or, when necessary, through discussion with a third reviewer. Quality scores would not be assigned
to studies, but the results of quality assessment were to be discussed
in the report.

As no RCTs or controlled studies were identified, meta-analysis


was not possible.

RESULTS

Description of studies
See: Characteristics of excluded studies.
In the HTA review (Bagnall 2003), 68 studies were identified that
addressed the question of spinal fixation surgery for acute traumatic SCI. All studies included a control group, in that a group receiving spinal fixation surgery was compared to a group not receiving spinal fixation surgery. However, all studies were retrospective
observational studies and of poor quality. There was some doubt
over the comparability of groups and/or on confounding factors
in many of the studies. Often, the decision on whether to treat
surgically or not was made based on the severity of the patients
injuries (more severe injuries led to non-operative treatment in
some units and to operative treatment in others). In many studies, results of surgery with and without fixation were reported together. In a number of other studies, few details of baseline severity
or patient demographics were reported. A full discussion of these
studies, including full data extraction and quality assessment tables, is available in the HTA review.
Update searches, conducted for this review in May 2003 and May
2007, located a further 3106 records. Of these, 10 were retrieved
for full inspection. No relevant RCTs or controlled trials were
identified. The majority of the identified studies were retrospective case series and did not directly investigate whether spinal fixation surgery resulted in better outcomes than no spinal fixation
surgery. One study (Brodke 2003) compared anterior and posterior surgical approaches in a RCT. Another study (Kerwin 2005)
was a retrospective review of the effects of spinal fixation within
3 days. One literature review (Kishan 2005) and one systematic
review (Fehlings 2006) were also found. Both suggested that early
decompression surgery may be beneficial, but did not find strong
evidence about the effects of spinal fixation surgery.

Risk of bias in included studies


No studies were included.

Effects of interventions
No studies were included.

DISCUSSION

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

No RCTs or controlled trials were identified that answered the


question whether there is a difference in functional ability or other
commonly measured outcomes for those who have had spinal fixation surgery and those who have not. All of the studies identified
in the original and update searches were retrospective and of poor
quality. The limitations of this type of study design meant that all
of the identified studies suffered from a number of methodological
flaws. The validity of the studies may be affected by confounding
and other biases, but often important variables that could affect the
study results are not reported in sufficient detail to allow the reader
to make a judgement. In the future, studies of any design should
report more details of participants and outcomes (for example, the
Injury Severity Score (ISS) or similar standardised measure, and
the level of SCI should be reported). Data could then be stratified
according to injury level. This is important because conservative
treatment for SCI differs according to the level of injury (conservative treatment for cervical fractures is quite different from conservative treatment of thoracic or lumbar fractures). Patient characteristics should be reported as these may also differ according
to injury level (for example cervical fractures are predominantly
seen in the elderly). MRI findings should also be reported, where
applicable, along with details of all treatments given, including
whether post operative external bracing was used. It should also
be noted that in retrospective studies the severity of injury will
impact the decision whether to treat surgically or not: more severe
injuries will lead to non-operative treatment in some studies and
operative treatment in others. Studies with historical controls have
additional biases in that aspects of care other than the decision to
treat surgically or not will differ between treatment and control
groups.

Well-designed, prospective randomised controlled trials with ap-

propriately matched controls are needed. If this is not possible, at


the very least well-designed prospective cohort studies with concurrent and appropriate controls are required. Outcomes should
be reported in a standardised way, giving as much information
as possible for treatment and control groups, and outcomes that
are important to patients, their families and carers, as well as clinicians, should be measured and reported. People with SCI, and
their representatives, should be involved in the design of future
research studies to ensure the research is relevant and useful.

AUTHORS CONCLUSIONS
Implications for practice
The current evidence is insufficient to enable the author to comment on the benefits or harms of spinal fixation surgery in patients
with traumatic SCI.

Implications for research


Well-designed, prospecive experimental studies with appropriately
matched controls are required to assess the benefits or harms that
may be associated with spinal fixation surgery. All future research
should be planned in association with people with SCI and their
carers to ensure that appropriate and relevant research is carried
out.

ACKNOWLEDGEMENTS
We wish to thank Steven Duffy for conducting the initial and
2003 update searches for this review.

REFERENCES

References to studies excluded from this review


Brodke 2003 {published data only}
Brodke DS, Anderson PA, Newell DW, Grady MS,
Chapman JR. Comparison of anterior and posterior
approaches in cervical spinal cord injuries. Journal of Spinal
Disorders and Techniques 2003;16:22935.
Fehlings 2006 {published data only}
Fehlings MG, Perrin RG. The timing of surgical
intervention in the treatment of spinal cord injury: a
systematic review of recent clinical evidence. Spine 2006;
31:S2835.
Kerwin 2005 {published data only}
Kerwin AJ, Frykberg ER, Schinco MA, Griffen MM,
Murphy T, Tepas JJ. The effect of early spine fixation on
non-neurologic outcome. Journal of Trauma 2005;58(1521).

Kishan 2005 {published data only}


Kishan S, Vives MJ, reiter MF. Timing of surgery following
spinal cord injury. Journal of Spinal Cord Medicine 2005;28:
119.
La Rosa {published data only}
La Rosa G, Conti A, Cardali S, Cacciola F, Tomasello F.
Does early decompression improve neurological outcome of
spinal cord injured patients? Appraisal of the literature using
a meta-analytical approach. Spinal Cord 2004;42:50312.
McKinley {published data only}
McKinley W, Meade MA, Kirshblum S, Barnard B.
Outcomes of early surgical management versus late or no
surgical intervention after acute spinal cord injury. Arch
Phys Med Rehabil 2004;85:181825.
Moon {published data only}
Moon MS, Choi WT, Moon YW, Kim YS, Moon JL.

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Stabilisation of fractured thoracic and lumbar spine with


Cotrel-Dubousset instrument. Journal of Orthopaedic
Surgery 2003;11:5966.

Geisler 1988
Geisler FH. Acute management of cervical spinal cord
injury. Maryland Medical Journal 1988;37(7):52530.

Sustic {published data only}


Sustic A, Krstulovic B, Eskinja M, Zelic N, Ledic D, Turina
D. Surgical thracheostomy versus percutaneous dilational
tracheostomy in patients with anterior cervical spine
fixation: preliminary report. Spine 2002;27:19425.

Harrison 2000
Harrison P. Managing spinal injury: critical care. the initial
management of people with actual or suspected spinal cord
injury in high dependency and intensive care units. Spinal
Injuries Association. London, 2000.

Wang {published data only}


Wang D, Teddy PJ, Henderson NJ, Shine BS, Gardner BP.
Mobilization of patients after spinal surgery for acute spinal
injury. Spine 2001;26:227882.

McDonald 2002
McDonald JW, Sadowsky C. Spinal-cord injury. Lancet
2002;359(9304):41725.

Wang (b) {published data only}


Wang D, Bergstrom E, Clarke M, Henderson N, Gardner
B. Mobility of the spine after spinal surgery in acute spinal
cord injury. Spinal Cord 2003;41:5939.

Additional references
Amar 1999
Amar AP, Levy ML. Surgical controversies in the
management of spinal cord injury. Journal of the American
College of Surgeons 1999;188(5):55066.
British Orthopaedic
British Orthopaedic Association. The Initial Care and
Transfer of Patients with Spinal Cord Injuries. British
Orthopaedic Association, 2006.
Donovan 1994
Donovan WH. Operative and nonoperative management of
spinal cord injury: a review. Paraplegia 1994;32(6):37588.
El Masri 2006
El Masri WS. Traumatic spinal cord injury: the relationship
between pathology and clinical implications. Trauma 2006;
8:2946.

NHS CRD 2001


NHS CRD. Undertaking Systematic Reviews of Research
on Effectiveness. CRD, University of York. 2. York, 2001.
Smith 1999
Smith M. Making the difference: efficacy of specialist versus
non-specialist management of spinal cord injury. Spinal
Injuries Association. London, 1999.
Wyndaele 2006
Wyndaele M, Wyndaele JJ. Incidence, prevalence and
epidemiology of spinal cord injury: what learns a worldwide
literature survey?. Spinal Cord 2006;44:5239.

References to other published versions of this review


Bagnall 2003
Bagnall AM, Jones L, Duffy S, Richardson G, Riemsma R.
Effectiveness and cost-effectiveness of acute hospital-based
spinal cord inuries (SCI) services: a systematic review. NHS
R&D HTA Programme. Southampton, 2003; Vol. 01/28/
01.

Indicates the major publication for the study

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

CHARACTERISTICS OF STUDIES

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Brodke 2003

No non-fixation surgery control group.

Fehlings 2006

Systematic review.

Kerwin 2005

Retrospective observational study.

Kishan 2005

Literature review.

La Rosa

Literature review.

McKinley

Retrospective observational study.

Moon

RCT but no non-fixation surgery control group.

Sustic

RCT but no non-fixation surgery control group.

Wang

Retrospective observational study.

Wang (b)

Retrospective observational study.

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

DATA AND ANALYSES


This review has no analyses.

WHATS NEW
Last assessed as up-to-date: 9 October 2007.

Date

Event

Description

11 September 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 2, 2004
Review first published: Issue 1, 2008

CONTRIBUTIONS OF AUTHORS
AM Bagnall - wrote protocol
L Jones - wrote protocol
S Duffy - designed and carried out search strategy
R Riemsma - oversaw project, provided comments and input at all stages

DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT
Internal sources
Centre for Reviews and Dissemination, University of York, UK.

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

External sources
Health Technology Assessment (HTA) Programme, NHS, UK.

INDEX TERMS
Medical Subject Headings (MeSH)
Randomized Controlled Trials as Topic; Spinal Cord Injuries [ surgery]; Spinal Fusion [ methods]

MeSH check words


Humans

Spinal fixation surgery for acute traumatic spinal cord injury (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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