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ORIGINAL ARTICLE
a
Academic Orthopaedics and Trauma Surgery Unit, Michallon Hospital, 38043 Grenoble Cedex 09, France
b
Neurosurgical Academic Unit, Salengro Hospital, boulevard Professeur-Emile-Leyne, 59037 Lille, France
c
Orthopaedic and Traumatology Academic Department, Bictre Hospital, rue du General-Leclerc, 94275 Le Kremlin Bictre,
France
KEYWORDS Summary
Spine fractures; Background: Osteoporotic spine fractures induce a heavy burden in terms of both general health
Osteoporosis; and healthcare costs. The objective of this multicentre study by the French Society for Spine
Vertebroplasty; Surgery (SFCR) was to compare outcomes after vertebroplasty and kyphoplasty in the treatment
Kyphoplasty of osteoporotic thoracolumbar vertebral fractures.
Hypothesis: We hypothesised that differences existed between vertebroplasty and kyphoplasty,
notably regarding operative time and reduction efcacy, from which criteria for patient selec-
tion might be inferred.
Material and methods: We conducted a retrospective multicentre review of 127 patients with
Magerl Type A low-energy fractures after a fall from standing height between 2007 and 2010; 85
were managed with vertebroplasty and 42 with kyphoplasty. Age was not a selection criterion.
We recorded pain intensity, time to management, operative time, kyphosis angle, wedge angle,
cement leakage rate, and degree of cement lling.
Results: Operative time was 43 minutes with kyphoplasty and 24 minutes with vertebroplasty
(P = 0.0002). Both techniques relieved pain, with no signicant difference. Kyphoplasty signi-
cantly improved the wedge angle, by +6 , versus +2 with vertebroplasty (P = 0.002). With
kyphoplasty, the volume injected was larger and cement distribution was less favourable.
Leakage rates were similar.
Corresponding author.
E-mail address: LGarnier1@chu-grenoble.fr (L. Garnier).
1 94, rue Bobillot, 75013 Paris.
Discussion: Despite the heterogeneity of our study, our data conrm the effectiveness of kypho-
plasty in alleviating pain and decreasing deformities due to osteoporotic vertebral fractures.
Vertebroplasty is a faster and less costly procedure that remains useful; no detectable clinical
complications occur with vertebroplasty, which ensures better anchoring of the cement in the
cancellous bone.
Level of evidence: Level 4, retrospective cohort study.
2012 Published by Elsevier Masson SAS.
Introduction
45
40
Over 100 million individuals are at risk for new osteoporotic
35
spinal fractures worldwide [1,2]. Osteoporotic vertebral
30
fractures may occur in 20% of individuals older than 70 years
25
of age and 16% of postmenopausal women [3]. The main
20
manifestations are pain and a kyphotic deformity of the
15
spine. Kyphosis negatively impacts lung vital capacity, bowel
transit, quality of life, self-sufciency, and mood, ultimately 10
Number of patients 85 42
Number of treated levels 95 43
Mean age, years (range) 71 (4392) 59 (3294) P = 0.00001
Women (%) 74 46 P = 0.0131
Magerl A1 fracture 44 14 P = 0.129
Magerl A2 fracture 17 3 P = 0.091
Magerl A3 fracture 34 24 P = 0.045
angle (bKA) was the angle between the lines along the upper
endplate of the suprajacent vertebra and the lower endplate
of the infrajacent vertebra. Angles indicating kyphosis were
positive and those indicating lordosis were negative.
The following perioperative data were recorded: time to
operative management in days, volume of cement injected
in millilitres, operative time in minutes, and hospital stay
length in days. A neurological evaluation was performed
and the VAS pain score was determined immediately after
the procedure, before patient discharge. Anteroposterior
and lateral radiographs were obtained to measure the post-
operative wedge angle (poWA) and postoperative kyphosis
angle (poKA) and to evaluate the degree of cement lling
(Fig. 3). The volume injected is not sufcient to evaluate
Figure 2 Distribution of the fractured levels.
the technical quality of the procedure and we therefore
recorded the sites of cement leakage (Fig. 4). When leakage
rior uoroscopic guidance. The injection was stopped when was detected, computed tomography (CT) was performed to
lling was considered sufcient or cement leaked outside determine the exact location of the leak.
the vertebral body. Patients were seen 3 months after the procedure for
Kyphoplasty was also performed under general anaesthe- a physical evaluation, VAS pain score determination, and
sia. The patient was in the prone position. No particular anteroposterior and lateral radiographs centred on the frac-
position for the supports was specied. The trocars were ture for measurement of the 3-month wedge angle (m3WA)
inserted through the pedicles at the lumbar spine and and 3-month kyphosis angle (m3KA). Wedge reduction was
between the ribs and transverse processes at the thoracic computed as the difference between the baseline and post-
spine. KyphonTM device (Medtronic, Boulogne-Billancourt, operative wedge angles (bWApoWA) and kyphosis reduction
France) and introducer system were used. Under uoro- as the difference between the baseline and postoperative
scopic guidance, two balloons placed within the vertebral
body were lled with saline containing injectable contrast
material. Balloon lling and fracture reduction were mon-
itored by lateral uoroscopy. The cavity left after balloon
removal was lled with cement to stabilise the reduction.
The cement used was either KYPH X HV-RTM (Medtronic) or
a similar high-viscosity radio-opaque cement.
With both techniques, cement injection was preceded
by a manual check of viscosity, 4 minutes on average after
mixing started. The volume injected was recorded. After
the procedure, early sitting was allowed as possible without
pain, and ambulation was started on day 1. Braces were
not used.
Follow-up
Results
16
n 118 86 32
X1 2 2 0 NS
Y1 0 0 0 NS
Z1 5 3 2 NS
Grade 1 7 5 2 NS
X2 2 2 0 NS
Y2 16 12 4 NS
X3 1 0 1 NS
Grade 2 19 14 5 NS
Y3 6 3 3 NS
Z2 12 5 7 NS
Z3 74 59 15 0.03
Grade 3 92 67 25 0.98
X1, X2, X3, Y1, Y2, Y3, Z1, Z2, Z3: see Fig. 3. NS: not signicant.
Discussion the leak rates. In our study, anterior leaks were more com-
mon with vertebroplasty, although the difference was not
Study limitations statistically signicant. Complications were not signicantly
different between our two groups. In contrast, Taylor et al.
reported higher rates of pulmonary embolism and neurolog-
Our study has multiple biases related to the retrospective
ical complications after vertebroplasty [21]. We recorded
multicentre design. In addition, the kyphoplasty patients
no new fractures, but follow-up was brief in our study. The
were recruited at several centres, whereas nearly all the
treated level had no inuence on the quality of reduction in
vertebroplasty patients came from a single centre. Mean
either group. In contrast, Phillips et al. reported a mean KA
age was older in the vertebroplasty than in the kyphoplasty
improvement of 8.8 with larger gains at the thoracic lev-
group, despite the use of low-energy trauma as an inclusion
els than at the lumbar levels [30]. Finally, the WA improved
criterion. The practice habits in each centre seem to play
signicantly with both techniques. After 3 months, mean
a major role. Early vertebroplasty or kyphoplasty, as per-
KA was 12 after vertebroplasty and 14 after kyphoplasty,
formed in this case-series, was not considered in patients
with no clinical differences, suggesting that restoring a WA
older than 80 years. However, in neither group did we nd a
greater than 10 may be benecial. However, no target
correlation between age and WA improvement. The choice
WA value has been published to date. The KA improve-
between cement injection and initial bracing was at the dis-
ments noted in our study were not statistically signicant
cretion of each centre instead of being based on specic
(1 on average in both groups). The correlation between the
criteria, given the absence of published recommendations.
improvements in KA and WA was weak (correlation coef-
Thus, in some centres cement injection was performed only
cient, 0.39). Thus, correcting the wedge deformity does
in patients with persistent pain despite bracing. Further-
not reduce the kyphotic deformity. It seems that the WA
more, each centre used its own denition of low-energy
improvement is consumed in the adjacent disks. Shin
trauma, which may explain the age difference and broad
et al. reported a 7 improvement in the KA immediately
indications for kyphoplasty in some centres.
after the procedure [31] and Teng et al. a KA improvement
The lack of accuracy inherent in manual measurement
of 4.5 to 5 [32]. The quality of reduction is consistently
of angles and heights is another limitation of our study. In
better in Magerl A3 fractures. Therefore, the higher preva-
addition, the double concavity of the upper endplate may
lence of these fractures in the kyphoplasty group introduced
impair the ability to accurately position the upper endplate.
a bias that should be taken into account when interpreting
The analysis of impaction and reduction at the centre of the
the results. For Magerl A1 fractures, which are more dif-
endplate, which is the only means of effectively improv-
cult to reduce, we found no evidence that one technique
ing mechanical support to the intervertebral disc, would be
was superior over the other.
more accurate if performed on routine computed tomog-
raphy images. Finally, the clinical evaluation in our study
patients was limited to the VAS pain score. Determining a
Technique
functional score is difcult in the oldest patients. We there-
fore focused on short-term structural improvements and
We noted a number of technical differences between ver-
pain relief.
tebroplasty and kyphoplasty. With vertebroplasty, patient
positioning under general anaesthesia to increase spinal
Outcomes lordosis is the main method used to reduce the defor-
mity [3234]. Carlier et al. reported better reduction in
Vertebroplasty and kyphoplasty produced similar outcomes cases with intravertebral clefts [3335]. Tropiano et al.
in terms of pain, cement leaks, complications, and reduc- obtained good outcomes with closed reduction using a Cotrel
tion of the deformity. Our data on pain are consistent with frame followed by casting [36]. In our study, hyperlordo-
earlier reports [15,2124]. We did not evaluate function sis ensured a 2 improvement in the WA immediately after
at last follow-up. The consensus at present is that early surgery. Cement injection during vertebroplasty stabilises
vertebroplasty or kyphoplasty to treat vertebral fractures the fracture by lling the spaces created in the cancellous
improves survival and quality of life and allows an earlier bone during reduction. Reinforced trocars have been devel-
return to work [2426]. A 7% increase in survival has been oped to ensure lifting of the upper endplate during cement
reported with kyphoplasty compared to vertebroplasty. The injection; however, no comparative studies establishing the
better reduction achieved using kyphoplasty has not been efcacy of this method are available. The use of balloon
proven to result in short-term benets. In our study, the tamps was suggested to better reduce the deformity by lift-
leak rate and topographic distribution of the leaks (with a ing the upper endplate [21,24,30,3743]. Our data conrm
predominance of lateral and cranial leaks) were comparable that kyphoplasty produces greater WA gains, although there
in the two groups. Leaks had no adverse clinical effects in is no evidence that these translate into clinical benets.
our patients. Kyphoplasty has been reported to decrease the Other methods for achieving reduction via intracorporeal
number of leaks [19,2729]. The high leak rate in our study procedures are being developed. The Spinejack (Vexim SA,
is ascribable to injection of the cement at a low-viscosity Balma, France) is a jack-like device that is introduced via a
stage and in a large volume of 7 mL on average in the kypho- pedicle into the vertebral body before the cement injection.
plasty group. The current trend is to inject at a higher A vertebral body stenting system has also been introduced
viscosity stage, after a longer mixing time. Since the early (VBS, Synthes, Issy-les-Moulineaux France). These promis-
studies, in addition to changes in available cements, tech- ing methods need to be evaluated in clinical and economic
nical progress made by surgeons has contributed to diminish studies.
S118 L. Garnier et al.
Table 5 Review of the literature. Improvements in pain, angles, and vertebral heights across methods.
In our case-series, the differences in operative tech- the company THIEBAUD MDICAL. A. Bodin: no nancial
niques explain the differences in operative time, lling, relationship with industy. H. Vouaillat: consultant com-
and impact of time to treatment. The operative time for pany Medtronic. R. Assaker: consultant company Medtronic.
vertebroplasty was half that for kyphoplasty. This point C. Court: consultant company Medtronic. P. Merloz: no con-
deserves consideration given that patients with compres- icts of interest concerning this article.
sion fractures are often frail. Performance of the procedure
on an ambulatory basis with a brief general anaesthesia
may be possible. We found no previous data on vertebral Acknowledgements
body lling by the cement. In our study, vertebroplasty
was associated with uniform lling (Z3, Fig. 3), both in the We are grateful to Dr T. Aubert, Dr Y.-P. Charles, Dr
cranio-caudal direction and from side to side. With kypho- P. Marinho, Dr J. Michel, Dr M. Saget, Prof. L.-E. Gayet, and
plasty, bone compression during expansion of the balloon Prof P. Tropiano for contributing to collect the data for this
probably hinders the diffusion of the cement. We found a study.
weak correlation between time to operative management
and quality of the reduction. Similarly, Philips et al. reported
that the WA improvement was better when vertebroplasty References
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