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Operative Versus Non-Operative Treatment For Thoracolumbar Burst Fractures Without Neurological Deficit (Review)
Operative Versus Non-Operative Treatment For Thoracolumbar Burst Fractures Without Neurological Deficit (Review)
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2006, Issue 4
http://www.thecochranelibrary.com
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) i
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]
Liao Yi1 , Bai Jingping2 , Jin Gele3, Taixiang Wu4 , XiLin Baoleri5
1 Department of Orthopaedics, The Kelamayi City Central Hospital of Xin Jiang, Kelamayi, China. 2 Department of Orthopaedics,
The Third Affiliated Hospital of Xin Jiang Medical University, Urumqi, China. 3 Department of Orthopaedics, The First Affiliated
Hospital of Xin Jiang Medical University, Urumqi, China. 4 Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital,
Sichuan University, Chengdu, China. 5 Department of Orthopaedics, The Second Affiliated Hospital of Xin Jiang Medical University,
Urumqi, China
Contact address: Liao Yi, Department of Orthopaedics, The Kelamayi City Central Hospital of Xin Jiang, Kelamayi, Xin Jiang, 834000,
China. liaoyi6233005@yahoo.com.cn. liaoyi6233005@hotmail.com.
Citation: Yi L, Jingping B, Gele J, Wu T, Baoleri X. Operative versus non-operative treatment for thoracolumbar burst
fractures without neurological deficit. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD005079. DOI:
10.1002/14651858.CD005079.pub2.
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Spinal burst fractures result from the failure of both the anterior and the middle columns of the spine under axial compression loads.
Conservative management is through bed rest, and immobilization with a brace once the acute symptoms have settled. Surgical treatment
involves either anterior or posterior stabilization of the fracture with screws, often with decompression, an operation to remove bone
fragments which have intruded into the vertebral canal.
Objectives
To compare operative with non-operative treatment for thoracolumbar burst fractures without neurological deficit.
Search methods
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialized Register (May 2005), the Cochrane Central Register of
Controlled Trials (The Cochrane Library Issue 2, 2005), MEDLINE (January 1966 to April 2005), EMBASE (January 1988 to April
2005), and the Chinese Biomedical Literature Database (CBM) available at http://cbm.imicams.ac.cn (January 1978 to April 2005).
We also searched reference lists of articles, handsearched journals and conference proceedings, and contacted authors where necessary.
Selection criteria
Randomized controlled trials (RCTs) comparing operative with non-operative treatment of thoracolumbar burst fractures without
neurological deficit.
Data collection and analysis
Two review authors assessed trial quality and extracted data independently. Pooling of data was not carried out as only one small, poor
quality trial was included.
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 1
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
We included one trial comparing operative with non-operative treatment (53 participants).
There was no statistically significant difference in pain and function-related outcomes, rates of return to work, radiographic findings
or average length of hospitalization at final follow up. The rate of complications was higher for the patients treated operatively. The
degree of kyphosis or the percentage of correction lost did not correlate with any clinical symptoms at the time of the final follow up.
Average costs related to hospitalization and treatment in the operative group appeared to be more than in the non-operative group.
Authors’ conclusions
There was no statistically significant difference on the functional outcome two years or more after therapy between operative and non-
operative treatment for thoracolumbar burst fractures without neurological deficit. However, this review was able to include only one
randomized controlled trial with a small sample size and poor quality, which precluded firm conclusions. More research with high
quality trials is needed.
Comparing conservative treatment with surgery for people with fractures of the spine where fragments of fractured thoracolum-
bar vertebral bodies have protruded into the vertebral canal but not caused any obvious nerve damage
The thoracolumbar vertebral column (T11 to L2) is a common site of spinal injury. Motor vehicle accidents are the commonest cause of
injury, followed by falls and sports-related injuries. Fractures can be associated with acute back pain, limited motion, and swelling at the
fracture site. Pain may not be felt immediately but may begin hours later. If the nerve root or spinal cord is damaged, partial or complete
loss of sensory and motor function in the legs, urinary and fecal incontinence may result. Although many injuries do not cause paralysis
they may leave an unstable spinal segment and later paralysis. People are treated in hospital either conservatively by being placed in
a lying position that reduces strain on that part of the spine followed by fitting a cast or brace and moving around or by surgically
placing instrumentation with screws to stabilize the affected part of the spine. The review authors found only one trial from the US in
which 53 adults with stable thoracolumbar burst fracture were randomized to either wearing a body cast or undergoing surgery. The
people treated conservatively had less pain one to two years later at the last follow-up examination. There was no difference between the
two treatment strategies in the number of people returning to work or with respect to a hunching deformity of the back. The average
duration of hospitalization was not significantly different between groups although the average charges related to hospitalization and
treatment was more in the surgery group and rate of complications was higher. This review was limited by only one small trial being
available for stable burst fractures.
BACKGROUND L2) is a common site of spinal injury (Denis 1983; McEvoy 1985).
Spinal burst fractures result from failure of both the anterior and It forms a transition zone between the relatively fixed and kyphotic
the middle columns of the spine under axial compression loads, thoracic spine above, and the relatively mobile and lordotic lum-
frequently associated with flexion loading. In the three column bar spine below, which causes stress force to concentrate upon the
theory of spinal stability (Denis 1983), the anterior column is thoracolumbar vertebral column, and predisposes this area to in-
composed of the anterior half of the vertebral body and its adjacent jury (Gertzbein 1992). Motor vehicle accidents are the commonest
soft tissue complex; the middle column consists of the posterior cause of injury, followed by falls and sports-related injuries (Price
half of the vertebral body and soft tissue complex; and the poste- 1994). Thoracolumbar burst fractures account for up to 17% of
rior column is formed by the osseous and ligamentous structures major spinal fractures (Denis 1983). Males are at four times higher
posterior to the vertebral body. risk than females. Other organ system injuries occur in up to 50%
of thoracolumbar trauma patients (Purcell 1981; Weinstein 1988).
The thoracolumbar region, which comprises the eleventh and High-energy injuries associated with paraplegia have a 7% first-
twelfth thoracic, and first and second lumbar vertebrae (T11 to
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 2
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
year mortality rate (Shikata 1990). The incidence of neurological Non-operative treatments include recumbent bed rest and pos-
deficit resulting from thoracolumbar burst fractures is estimated tural reduction, followed by casting/bracing with early ambula-
to be 50% to 60% (Denis 1983; McEvoy 1985). tion. In the traditional conservative management of unstable tho-
racolumbar injuries the patient was confined to bed with great
The clinical features of thoracolumbar fracture include acute back
attention paid to lordotic posture for as long as six to eight weeks
pain, limited motion, and swelling at the fracture site. Pain may
followed by gradual mobilization (Bedbrook 1975). However, this
not be felt immediately, and may begin hours after the injury.
regimen resulted in mortality rates as high as 90% (Bedbrook
Damage to the nerve root and/or spinal cord from protruding
1975). Holdsworth 1970 recommended postural reduction of the
fragments of vertebral body may result in partial loss of sensory
deformity which resulted from the burst fracture, followed by hy-
and motor function in the lower extremity, or in cases of severe
perextension casting and patient mobilization. This brought on
disruption, may produce full paralysis, urinary and fecal inconti-
significantly improved morbidity and mortality rates. Postural re-
nence and permanent neurological injury. Characteristic radiolog-
duction can produce an indirect decompression of the spinal canal,
ical findings of the fractures include moderate to marked anterior
and a well-fitted cast or orthosis also may maintain reduction and
wedging of the vertebral body, an increased interpedicular distance
prevent deformity, while late neurologic deterioration is uncom-
and narrowing of the spinal canal as a result of displacement of
mon (Cantor 1993; Chow 1996).
vertebral body fragments. Although many thoracolumbar spinal
Two surgical approaches, posterior and anterior, have been em-
injuries do not result in paralysis, they may leave an unstable spinal
ployed to reduce and stabilize thoracolumbar fractures. Two tech-
segment due to disruption of bony elements and soft tissues. Late
niques have utilized the posterior approach. Isolated posterior re-
paralysis may result from the residual instability (Denis 1983).
duction and stabilization (Dickson 1978), using the Harrington
Denis 1983 proposed a classification of thoracolumbar fractures distraction rod system, demonstrated that this technique produced
into four types, based on the three column theory. restoration of vertebral height at the injured level, reduction of
the kyphosis, and spinal canal clearance to some degree. However,
(1) Simple anterior wedge/compression fracture.
the instrumentation had some drawbacks. It required fixation two
(2) Burst fracture. levels caudal (lower) and three levels cephalad (higher) than the
fracture. In addition, it offered only semirigid fixation, thus sup-
(3) Flexion-distraction injury/seat belt injury. plemental external support was often necessary. Over the past ten
(4) Fracture-dislocation. and more years, pedicle screw systems have become popular as a
treatment for thoracolumbar burst fractures. They provide rigid,
Burst fractures were sub-divided into five fracture patterns. three-column fixation, and only apply instrumentation to one or
(1) Fracture of both end plates. two motion segments. Short segment fixation reduces operative
time and the bulk of internal fixation material, and preserves max-
(2) Fracture of the superior end plate (the most common). imal motion of the vertebral column (McKinley 1997). However,
(3) Fracture of the inferior end plate (rare). short-segment transpedicular fixation of thoracolumbar burst frac-
tures has been associated with an unacceptable rate of failure, in-
(4) Burst rotation. cluding progressive kyphosis, and screw breakage (McLain 1993).
(5) Burst lateral flexion. Since it is the anterior and middle columns of the vertebrae which
are mainly involved in thoracolumbar burst fractures, others (Esses
In addition, Denis 1983 defined three patterns of instability: first 1990; Gertzbein 1992; Okuyama 1996) have argued that anterior
degree (mechanical), second degree (neurological), or third degree surgery could produce a more complete and reliable decompres-
(mechanical and neurological). sion of the canal, and a biomechanically sound reconstruction,
with rigid stabilization that allows early rehabilitation, return to
work, and gainful employment. However, the anterior approach
Management options requires more sophisticated surgical technique. Compared with
the posterior approach, there may be additional adverse effects
The goals of treatment for thoracolumbar burst fractures are to
such as increased blood loss, prolonged operative and anaesthetic
obtain early patient mobilization and a painless, balanced, stable
time, and surgically-induced disturbance of urinary function.
vertebral column with maximum spine mobility and optimal neu-
In the last two decades, surgical intervention has largely replaced
rological function (Eskenazi 2000). Basing on the mode and grade
conservative treatment in cases of thoracolumbar burst fractures
of injury associated with the clinical manifestation, management
with neurological deficit. However, there is controversy regarding
strategies include, but are not limited to, the following: (1) con-
treatment for thoracolumbar burst fracture without neurological
servative (non-operative) therapy, (2) isolated posterior stabiliza-
deficit (Okuyama 1996). Advocates of conservative treatment cite
tion (with or without decompression), and (3) isolated anterior
cohort studies demonstrating good outcomes, low progression of
decompression and stabilization (Resnick 1998).
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 3
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
deformity, less back pain, satisfactory work status, low incidence Types of outcome measures
of neurological deterioration, progressive bony remodeling and
diminution of canal compromise (Cantor 1993; Chow 1996;
Weinstein 1988). Although some studies argue that the degree Primary outcomes
of kyphosis does not correlate to clinical outcomes, others have
• Proportion of patients who recovered according to self and/
demonstrated a relationship between significant deformity (> 30
or a clinician’s assessment (e.g. pain assessed by visual analogue
degrees) and increased pain (Gertzbein 1992; Weinstein 1988).
scale (VAS)).
Although in one study of nonsurgical treatment with poor follow
• Proportion of patients who had an improvement in
up, the incidence of late neurological deterioration was 17% (
function measured on a disability or quality of life scale (e.g.
Denis 1984), others have reported much lower rates between 0%
Oswestry Disability Scale and/or Roland Disability Scale).
and 3% (Cantor 1993; Chow 1996; Weinstein 1988).
• Return to work.
In conclusion, the decision to treat thoracolumbar burst frac-
• Economic data as available.
tures without neurological deficit operatively or non-operatively
• Rate of subsequent surgery.
remains controversial. Thus, a systematic review of randomized
• The rate of complications: (1) fatal, (2) life threatening, (3)
controlled trials comparing different methods of treatment for
neurological deterioration, (4) decubitus ulcers, (5) infection, (6)
patients with thoracolumbar burst fractures without neurological
implant failure.
deficit is justified.
Secondary outcomes
• Sagittal plane kyphosis.
OBJECTIVES • The sagittal balance of the patient.
To compare the outcomes of non-operative compared with oper- • The degree of canal compromise.
ative treatment for thoracolumbar burst fractures without neuro- • Correlation between the final amount of kyphosis/canal
logical deficit. compromise and the pain reported or disability.
• The mean duration of hospitalization.
METHODS
Search methods for identification of studies
We searched the Cochrane Bone, Joint and Muscle Trauma Group
Criteria for considering studies for this review Specialized Register of trials (May 2005), the Cochrane Cen-
tral Register of Controlled Trials (The Cochrane Library Issue 2,
2005), MEDLINE (January 1966 to April 2005), EMBASE (Jan-
uary 1988 to April 2005), and the Chinese Biomedical Literature
Types of studies
Database (CBM) available at http://cbm.imicams.ac.cn (January
Randomized controlled trials and quasi-randomized trials com- 1978 to April 2005), and references lists of articles. No language
paring non-operative with operative treatment of thoracolumbar restrictions was applied. The search concluded in May 2005.
burst fractures without neurological deficit. In MEDLINE (OVID) a subject-specific search was combined
with the optimal trial search strategy (Higgins 2005a) (see
Appendix 1), and modified for use in The Cochrane Library
Types of participants
(see Appendix 2), EMBASE (see Appendix 3), and the Chinese
Any adult, aged 18 or over, with a radiologically confirmed, re- Biomedical Literature database (see Appendix 4).
cent (less than three weeks) thoracolumbar burst fracture without We handsearched the following conference proceedings: the Amer-
neurological deficit. ican Orthopaedic Association Annual Meeting (from 1999 to
2004), North American Spine Society Annual Meeting (from 2000
to 2004), Orthopaedic Trauma Association Annual Meeting (from
Types of interventions 1999 to 2004), American Academy of Orthopaedic Surgeons An-
Known conservative treatments including recumbency, postural nual Meeting (from 1999 to 2004), final programmes of SICOT
reduction followed by casting or bracing, and early ambulation. (1996, 1999 and 2002), the British Orthopaedic Association An-
The comparators were operative treatment, which was either iso- nual Congress (from 2002 to 2004), The International Society
lated posterior stabilization (with or without decompression), or for the Study of the Lumbar Spine and The Spine Society of Aus-
isolated anterior decompression and stabilization. tralia 2004 to 2005: http://abstracts.spinejournal.com (accessed
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 4
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
08 June 2006). We also handsearched the following Chinese jour- number randomized and the numbers analyzed were inconsistent,
nals: Chinese Journal of Traumatology (from 1985 to May 2005), we would calculate the percentage lost to follow up and reported
the Journal of Cervicodynia & Lumbodynia (from 1980 to May this information in an additional table. For binary outcomes, we
2005), and the China Journal of Orthopaedics and Traumatology would record the number of participants experiencing the event in
(from 1987 to May 2005). each group of the trial. For continuous outcomes, for each group
We tried to identify ongoing and unpublished trials by searching we would extract the arithmetic means and standard deviations.
the following databases: Current Controlled Trials (http://con-
trolled-trials.com), the UK National Research Register (Issue 2,
2005 at http://www.update-software.com/national/search.htm), Data analysis
Clinical Trials.gov (http://clinicaltrials.gov), and by contact with We planned to pool data from trials if they were sufficiently simi-
authors of relevant trials. lar i.e. we would not combine results of trials with different com-
parator operative treatments. However, as only one RCT met the
criteria we provide a descriptive summary only.
Data collection and analysis If enough suitable trials for meta-analysis become available in the
future, we will use the following approach:
We will analyze the data using Review Manager (RevMan). We
will compare outcome measures for binary data using relative risks
Study selection
and we will use the weighted mean difference for continuous data.
Liao Yi (LY) scanned the results of the search, and retrieved the Heterogeneity will be tested for using the chi squared statistic, with
full articles, for all potentially relevant trials. LY and Bai Jingping significance being set at P < 0.10, and the I2 statistic where a value
(BJ) independently assessed each of these trials for inclusion and greater than 50% may be considered substantial heterogeneity
scrutinized each trial report for multiple publications from the (Higgins 2003).
same data set. We resolved any disagreement through discussion. Where it is appropriate to pool data but heterogeneity is detected,
We excluded studies that did not meet the inclusion criteria and we will use the random-effects model. We will explore the potential
stated the reason in the ’Characteristics of excluded studies’ table. sources of heterogeneity using subgroup and sensitivity analyses
as described below. Potential bias will be tested for using the fun-
nel plot or other corrective analytical methods depending on the
Assessment of methodological quality
number of clinical trials included in the systematic review (Egger
LY, BJ, WT, JG and XL assessed the methodological quality of 1997).
each trial in terms of generation of allocation sequence, allocation
concealment, blinding, and loss to follow up. For each trial, we
classed each quality components as ’adequate’, ’inadequate’, or Subgroup analyses
’unclear’ according to Juni 2001. Based on these criteria, studies We would aim to perform subgroup analyses in order to explore
were subdivided into one of the following three categories: effect size differences in relation to the the type of intervention
A (low risk of bias) - all quality criteria met adequately. and timing.
B (moderate risk of bias) - one or more of the quality criteria partly Reasons for heterogeneity in studies would be explored and, if
met. necessary, sensitivity analyses would examine the effects of exclud-
C (high risk of bias) - one or more of the criteria met inadequately ing study subgroups, e.g. those studies with lower methodological
or not used. quality.
We have displayed this information in an Additional Table (see
Table 1).
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 5
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
remaining two reports related to the same trial (Wood 2003) which Proportion of patients who had an improvement in function
was included. This trial compared operative (posterior or ante- measured on a disability or quality of life scale (Oswestry
rior arthrodesis and instrumentation) with non-operative treat- Disability Scale and/or Roland Disability Scale)
ment (application of a body cast or orthosis) (53 participants) (see
The proportion of patients who had an improvement in function
’Characteristics of included studies’ table for details).
measured on a disability or quality of life scale were not described.
The average score on the Oswestry questionnaire at the final fol-
low-up evaluation was 20.8 points (0 to 48 points) for the oper-
ative group and 10.7 points (0 to 52 points) for the conservative
Risk of bias in included studies group (where the lower score represents better function).
The randomization method in Wood 2003 is described as a “com- The average Roland and Morris pre-injury functional disability
puter-generated randomization process”. Allocation concealment scores was 1.9 points (0 to 9 points) for the operative group and
and blinding was unclear. Loss to follow up was described in detail, 0.7 point (0 to 7 points) for the conservative group. At the time of
and the rate was 11% (6/53). However, intention-to-treat analysis the last follow-up examination, the average score was 8.2 points
was not used. The methodological quality of the study is therefore (0 to 19 points) for the operative group and 3.9 points (0 to 24
at moderate risk of bias (Higgins 2005b). points) for the conservative group. The conservative group was
found to have significantly lower pain scores than the operative
group (P = 0.02).
Effects of interventions
The included trial contained 53 participants assigned randomly Return to work
to the operative or non-operative group; 26 received surgical treat-
Seventeen of the twenty-three patients treated non-operatively
ment and 27 were managed conservatively. The operative group
were able to resume work within six months and two returned
were treated with posterior or anterior arthrodesis and instrumen-
between six and twenty four months. Fifteen of them returned to
tation, while the non-operative intervention involved the applica-
a similar job, and four returned to a light job.
tion of a body cast or orthosis.
Ten of the twenty-four patients treated operatively returned to
The average duration of follow up was 44 months (minimum 24
work within six months after discharge, and four returned to work
months). Four patients (two from each group) were lost to follow
between six and twenty four months. Eight of them returned to
up because they could not be contacted. Two additional patients,
a similar job, and seven worked at a less physically demanding
who both came from the non-operative group, died from other
occupation (this included one patient who returned to work more
causes unrelated with injuries and interventions before the final
than twenty four months postoperatively).
follow up could be performed. Most of outcome measures were
narrated, but a few numerical data could not be provided, such
as tables showing demographic and radiographic data, and de-
tailed patient-reported outcomes and precise complications were Economic data
unavailable.
Among the patients who had an isolated thoracolumbar burst frac-
ture without other substantial trauma requiring specific treatment
during the initial hospitalization, the average charge for hospital-
Primary outcomes ization and cast or brace treatment for those treated non-opera-
tively was $11,264 ($4686 to $20,891), while the average charge
per injury for the group treated operatively was approximately
$49,063 ($26,517 to $102,583).
Proportion of patients who had recovered according to self
and/or a clinician’s assessment
The proportion of patients who recovered according to self and/ Rate of complications
or a clinician’s assessment could not be reported.
The average pain score using a visual analogue scale before treat- Adverse events were reported in sixteen participants in the oper-
ment of the injury was 6 cm (3 to 9 cm) for the operative group ative group compared with three in the non-operative treatment
and 5.8 cm (0 to 9 cm) for the non-operative group. At the last group. However, specific complications were not described.
follow-up examination, the average pain scores were 3.3 cm (0 to There was no neurological deterioration regardless of treatment
7.5 cm) and 1.9 cm (0 to 9 cm) respectively with no statistically approach, and neurological examination of all patients was normal
significant difference found between groups (P = 0.18) . at the time of the final follow up.
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 6
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Secondary outcomes With the numbers available for the pain and function-related out-
comes, it appears that the non-operative group were performing
better than the operative group with respect to pain either at the
Sagittal plane kyphosis time of presentation or at the final follow up. However, these dif-
In the group managed surgically, the average amount of kyphosis ferences were not statistically significant. The rates at which the
was 10.1 degrees (-10 degrees to 32 degrees) on admission and 5 patients returned to work were not found to be different between
degrees (-10 degrees to 25 degrees) at the time of discharge from the groups.
the hospital. However, average kyphosis was 13 degrees (-3 degrees Radiographically, sagittal plane kyphosis showed no statistically
to 42 degrees) at the time of the final follow up. significant difference between the two groups on admission, af-
ter treatment, or after long-term follow up. Both groups initially
In the non-operative group, the average amount of kyphosis was showed improvement in the kyphosis after treatment, although
11.3 degrees (-12 degrees to 30 degrees) on admission, 8.8 degrees those managed surgically were better; however, much of the cor-
(-5.5 degrees to 22 degrees) on discharge from the hospital, and rection was lost gradually during follow-up. Despite these results,
13.8 degrees (-3 degrees to 28 degrees) at the final follow-up ex- the degree of kyphosis at the time of the final follow up or the
amination. percentage of correction lost did not correlate with any clinical
At the time of final follow up, no statistically significant difference symptoms. The same is true for the degree of canal compromise.
was found between the two groups with respect to the sagittal
plane kyphosis (P = 0.6). Although there was no difference in average duration of hospi-
talization between the two groups, the average charges related to
hospitalization and treatment in the operative group were more
Degree of canal compromise than those in the non-operative group. In addition, the rate of
In the operative group, the average midsagittal diameter of the complications was higher for the patients treated surgically, which
spinal canal at the level of the fracture on presentation was 39% was ascribed to the fact that they had undergone an operative in-
(13% to 63%) less than normal, which improved to 22% (0% tervention. The rate of subsequent surgery and the sagittal balance
to 58%) at the final follow-up examination. In the non-operative of the patient were not stated, but they are common occurrences
group, the diameter was initially 34% (5% to 75%) less than after fractures of this kind, regardless of the method of manage-
normal, which also improved significantly to an average of 19% ment.
(0% to 46%) at the last follow-up examination. There were limitations in the review. As mentioned before, we
could include only one randomized controlled trial and the sample
size was small, which meant we could not draw satisfying and
Correlation between the final amount of kyphosis/canal
powerful conclusions. In addition, the small numbers involved
compromise and the reported pain or disability
made it impossible to answer some questions; for those managed
There was no correlation between the final amount of kyphosis surgically, it could not be determined whether an anterior or a
and the pain reported (r = 0.22; P = 0.29) or disability according posterior approach was superior. In the non-operative group, we
to the Roland and Morris questionnaire (r = 0.19; P = 0.39) or could not determine whether there is any difference between the
the Oswestry questionnaire (r = 0.25; P = 0.27) in the operative use of a cast and the use of a brace, the length of time that each
group, or the non-operative group, which was (r = 0.05; P = 0.8), should be worn or when and how to begin immobilisation.
(r = 0.05; P = 0.8) and (r = 0.3; P = 0.14) respectively.
Assessor blinding was unclear, and there was 11% loss of follow
up in the trial; these could allow detection and attrition biases.
Mean duration of hospitalization
Participants in the trial had suffered ’stable’ fractures (without pos-
The mean duration of hospitalization was 7.9 days (range 2 to 17 terior osteoligamentous complex injury). These are more com-
days) in the non-operative group and 10.7 days (range 6 to 27 mon in the population in which non-operative treatment yielded
days) in the operative group. acceptable outcomes and the additional benefits of surgery were
questionable.
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 7
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ment for stable thoracolumbar burst fractures without neurolog- deficit, which assures high internal validity. These studies should
ical deficit. The complications rate and overall costs in the oper- be conducted as randomized controlled trials with adequate ran-
ative group were higher. However, this review involves only one domization procedure, allocation concealment, blinding of out-
randomized controlled trial with a small sample size, so the conclu- come assessors and adequate handling of any attrition (by means
sion is short of stringency and its clinical use cannot be supported of reporting any losses to follow up and by performing intention-
on the basis of the trial. The nature of the surgical interventions to-treat analyses).
made double blinding impossible and there was loss to follow up,
which caused the trial involved to have a moderate risk of bias.
Its randomization procedure was adequate, however, so the results
had still some relevance. ACKNOWLEDGEMENTS
We thank Janet Wale, Peter Herbison, Rajan Madhok and Jeremy
Implications for research Fairbank for their comments on the review. We also thank Marc
There is a need for well reported, high quality RCTs using a Swiontkowski for helpful comments on the protocol. We are also
study design to assess the effect of operative versus non-operative grateful to Lesley Gillespie and Lindsey Shaw of the Cochrane
treatment for thoracolumbar burst fractures without neurological Bone, Joint and Muscle Trauma Group.
REFERENCES
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 9
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CHARACTERISTICS OF STUDIES
Wood 2003
Notes
Risk of bias
Shen 2001 Seven participants assigned to the operative group refused surgery and were reassigned to the non-operative group.
Three participants in the non-operative group did not complete the two-year study period and were excluded. This
study was excluded as the randomisation of patients was inadequate
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 10
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES
This review has no analyses.
ADDITIONAL TABLES
Table 1. Methodological quality of included studies
Blinding: Unclear
adequate or unclear or inadequate
Loss to follow up: There is loss to follow-up but intention-to-treat analysis is not
adequate or unclear or inadequate used at the time of statistics management
Scales: B
APPENDICES
MEDLINE (OVID)
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 11
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 12
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
#9. ((burst near fract*) or (burst near injur*) or (compression near fract*))
#10. (#8 and #9)
#11. (#7 or #10)
EMBASE (OVID)
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 13
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Appendix 4. Search strategy for the Chinese Biomedical Literature database
CBM Database
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 14
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
WHAT’S NEW
Last assessed as up-to-date: 10 August 2006.
HISTORY
Protocol first published: Issue 1, 2005
Review first published: Issue 4, 2006
CONTRIBUTIONS OF AUTHORS
Liao Yi: protocol development, searching for trials, quality assessment of trials, data extraction, data analysis, review development.
Bai Jingping: searching for trials, quality assessment of trials, data extraction, data analysis.
Wu Taixiang: quality assessment of trials, statistical advice.
Jin Gele: quality assessment of trials.
XiLin Baoleri: quality assessment of trials.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• Xin Jiang Medical University, China.
External sources
• No sources of support supplied
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 15
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
INDEX TERMS
Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (Review) 16
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.