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CLINICAL INVESTIGATION
Incidence of Symptomatic Vertebral Fractures in Patients AfterPercutaneous Vertebroplasty
Johannes Hierholzer Æ Heiko Fuchs Æ Kerstin Westphalen Æ Clemens Baumann ÆChristine Slotosch Æ Rudolf Schulz
Received: 30 January 2008 / Accepted: 27 May 2008 / Published online: 1 July 2008
� Springer Science+Business Media, LLC 2008
Abstract The aim of this study was to evaluate the inci-
dence of secondary symptomatic vertebral compression
fractures (VCFs) in patients previously treated by percuta-
neous vertebroplasty (VTP). Three hundred sixteen patients
with 486 treated VCFs were included in the study according
to the inclusion criteria. Patients were kept in regular fol-
low-up using a standardized questionairre before, 1 day,
7 days, 6 months, and 1 year after, and, further on, on a
yearly basis after VTP. The incidence of secondary symp-
tomatic VCF was calculated, and anatomical distribution
with respect to previous fractures characterized. Mean fol-
low-up was 8 months (6–56 months) after VTP. Fifty-two
of 316 (16.4 %) patients (45 female, 7 male) returned for
treatment of 69 secondary VCFs adjacent to (35/69; 51%) or
distant from (34/69; 49%) previously treated levels. Adja-
cent secondary VCF occurred significantly more often
compared to distant secondary VCF. Of the total 69
secondary VCFs, 35 of 69 occurred below and 27 of 69
above pretreated VCFs. Of the 65 sandwich levels gener-
ated, in 7 of 65 (11%) secondary VCFs were observed.
Secondary VCF below pretreated VCF occurred signifi-
cantly earlier in time compared to VCF above and
compared to sandwich body fractures. No major compli-
cation occurred during initial or follow-up intervention. We
conclude that secondary VCFs do occur in individuals after
VTP but the rate found in our study remains below the level
expected from epidemiologic studies. Adjacent fractures
occur more often and follow the cluster distribution of VCF
as expected from the natural history of the underlying
osteoporosis. No increased rate of secondary VCF after
VTP was observed in this retrospective analysis. In accor-
dance with the pertinent literature, short-term and also
midterm clinical results are encouraging and provide further
support for the usefulness and the low complication rate of
this procedure as an adjunct to the spectrum of pain man-
agement in patients with severe midline back pain due to
osteoporotic spine fractures.
Keywords Vertebroplasty � Osteoporosis �Pain palliation � Back pain � Follow-up
Introduction
Patients with severe osteoporosis typically suffer from
vertebral compression fractures (VCFs), which often cause
severe back pain. Such patients carry a significant risk of
increased morbidity including back pain, decreased activity,
bed rest, and even increased mortality [1, 2]. Osteoporotic
VCFs, in addition, are associated with an increased risk of
further painful VCF, resulting in height loss, kyphosis, and
increased risk of nonvertebral fractures [3, 4].
Minimal invasive vertebral augmentation techniques
such as percutaneous vertebroplasty (VTP) have proven to
be effective in treating the pain associated with VCF;
patients typically report rapid, significant, and durable pain
relieve and improvement in daily life performance after
VTP [5–8]. However, as in untreated patients, in patients
treated by VTP, the risk of new symptomatic vertebral
J. Hierholzer (&) � H. Fuchs � K. Westphalen � C. Baumann �C. Slotosch
Diagnostic and Interventional Radiology, Klinikum Ernst von
Bergmann gGmbH, Academic Teaching Hospital, Charite,
University Medicine Berlin, Charlottenstrasse 72, 14467
Potsdam, Germany
e-mail: [email protected]
R. Schulz
Musculoskeletal Surgery, Klinikum Ernst von Bergmann,
Potsdam, Germany
123
Cardiovasc Intervent Radiol (2008) 31:1178–1183
DOI 10.1007/s00270-008-9376-7
fractures has been reported to increase significantly with
the number of initial fractures [9]. The main discussion is
about whether these secondary fractures are to be consid-
ered a consequence and, therefore, complications of VTP,
or whether they represent the ongoing underlying disease
and would have occurred regardless of the presence of
bone cement in other levels [10–12]. A reduced incidence
of future VCF in patients after VTP could even suggest a
protective effect of VTP; however, no conclusive data have
been reported to date.
The purpose of this retrospective study was to evaluate
the incidence of new symptomatic VCF in patients treated
by VTP for osteoporotic VCF in a large single-center
cohort.
Materials and Methods
Patient Inclusion
After teaching of and training in percutaneous vertebropl-
asty by Claude Depriester at the University Hospital
Amiens, our spine augmentation program started in 2001
and a total of 865 symptomatic VCFs were treated in 581
patients until the initiation of this paper.
For the present analysis, the following patients were
excluded: malignant cause of fractures (85 patients), ver-
tebral hemangioma (2 patients), lesions treated by
kyphoplasty (76 patients), and patients treated by verteb-
roplasty in combination with surgery (2 patients). Nineteen
patients were lost to follow-up and therefore not included.
Since we found that the majority of additional fractures
occur within 6 month after the initial treatment, patients
with a follow-up of \6 months were also excluded (81
patients) [13]. Primary fractures treated were denoted
prevalent and secondary fractures were denoted incident
fractures for the present analysis.
Of the 316 patients with 486 prevalent fractures inclu-
ded, 52 experienced symptomatic incidental fractures
during follow-up and were subsequently retreated at our
institution. Demographic data on all included patients are
listed in Table 1.
Vertebroplasty Procedure
Prevalent and incident fractures were identified and treated
as outlined elsewhere [13]. Symptomatic patients under-
went MRI. A high signal on STIR sequences within
symptomatic vertebral bodies was regarded as sufficient
evidence for initial as well as follow-up treatment by VTP.
All patients recieved local anesthesia and intravenous
conscious sedation during treatment. Through the bilateral
transpedicular approach, two 11-G needles were advanced
into the vertebral body under fluoroscopic guidance in all
cases. A core biopsy through the VTP needle prior to
cement injection is standard procedure in our department to
exclude or prove malignancy. In addition, osseous phle-
bography by means of injection of iodine contrast medium
into the vertebral body to assure correct final needle posi-
tion is standard procedure in our department [14]. A
dedicated delivery system (Dual-Histo or CIS, Somatex,
Germany) was used to inject the bone cement (polymeth-
ylmethacrylate [PMMA]; Somatex) into the vertebral body.
We injected a mean volume of 2.5 ml of PMMA per
hemivertebra (2–6 ml per vertebra) and stopped injection
when cement reached the posterior fourth of the vertebral
body or when vascular or discoid leakages were observed.
According to the guidelines of the German Interdisci-
plinary Consensus Conference on Vertebroplasty and
Kyphoplasty, only symptomatic fractures were treated, and
only after unsuccessful conservative treatment [15]. In the
case of ‘‘sandwich bodies’’ (f.i. L2 and L4 to be treated),
the intermediate vertebral body was not prophylactically
treated. Postinterventionally all patients were kept in a
follow-up regime by regular telephone interview 1 day,
1 week, 1 month, 6 months, and then on a yearly basis
after treatment to assess future symptomatic fractures. In
the case of new onset or unsatisfactory relief of back pain,
patients were reinvited and clinical (physical examination)
as well as radiological (MRI using STIR sequences)
workup was repeated to prove or exclude symptomatic
incident fractures. Treatment of incidental fractures
occurred within 1 week after clinical and radiological
confirmation. Asymptomatic incidental fractures were not
considered in this analysis and were not treated.
Data Analysis
For the purpose of this study, the following data were
acquired: (a) frequency of symptomatic incidental fractures
during the follow-up period; (b) time interval between pre-
valent and incidental fracture treatments (considered as the
time lapse between the fractures themselves); (c) anatomic
distribution of secondary as well as incidental fractures; and
(d) anatomical distance between prevalent and incidental
fractures. Incidental fractures were designated above or
Table 1 Demographic data for patients included in the study
Patients N Female Male Age,
min
Age,
max
Mean
age
SD
Total 316 257 59 33 97 73 10
Without incidental
fractures
264 212 52 33 97 73 10
With incidental
fractures
52 45 7 53 87 72 8
J. Hierholzer et al.: Incidence of Symptomatic Vertebral Fractures in Patients After Percutaneous Vertebroplasty 1179
123
below and adjacent or distant to treated prevalent fractures,
respectively.
To calculate the incidence of adjacent and distant frac-
tures, two separate approaches were chosen: in the patient-
related incidence approach, the absolute figures were
compared (adjacent versus distant VCF); and in the ver-
tebral level-related incidence approach, we compared the
total number of vertebrae in every patient (counting from
TH4 to L5: 14 vertebrae) and separated all adjacent from
all distant vertebrae with respect to the treated level.
C1–TH3 were excluded since no fractures at this site ever
occurred in our osteoporotic population. From these data
we were able to calculate more specifically the refracture
rate for adjacent versus distant vertebrae. In order to ana-
lyze fracture occurrence in clusters as proposed by Trout
et al., we defined clusters of vertebral bodies as follows:
cluster 1, TH3–TH6; cluster 2, TH7–TH10; cluster 3,
TH11–L2; and cluster 4, L3–L5 [12].
In patients with multiple prevalent fractures and/or
multiple incidental fractures, the closest distance between
the prevalent level and the incidental fracture was regis-
tered, respectively. For patients with more than one event
of incidental fracture, only the first event was included, and
the remainder were not considered. Incidental fractures
occurring between two pretreated prevalent fractures
(sandwich fracture) were counted as adjacent-below levels.
For the purpose of comparison with other published data, a
subgroup of patients with postoperative follow-up of exactly
1 year at the time of this analysis was identified and data were
collected. A similar statistical approach as published by Trout
et al. was used for the present study [12]. Using SPSS for
Windows, chi-square test was used to compare the anatomical
distribution of fractures, while logrank Mantel-Cox analysis
was used to analyze the temporal course of incidental frac-
tures. A p-value of \0.05 was considered statistically
significant. Asymptomatic incidental fractures were not con-
sidered for this analysis and were not treated.
Results
Three hundred sixteen patients with symptomatic osteopo-
rotic VCFs were successfully treated by VTP. Pain improved
significantly in 294 of the 316 (93%) patients. Malignancy
was excluded in all individuals by bone biopsy. No major
complications occurred during initial or follow-up inter-
ventions. None of the patients treated returned with pain
within the previously treated vertebral body.
Frequency of Incidental Fractures
Four hundred eighty-six prevalent osteoporotic VCFs
treated in 316 patients by VTP (mean, 1.5 fractures per
patient; range, 1–5; see Table 2) and with a clinical follow-
up of C6 months (mean follow-up, 8 months; range,
6–56 months) were included in this analysis.
Excluding the cervical spine as well as TH1–TH3 in
every patient because of lack of osteoporotic fractures in
this anatomical region in our population, 14 vertebral
bodies (from TH4 to L5) can potentially fracture. Of these
4424 vertebrae (316 patients 9 14 vertebrae), 486 were
treated as prevalent fractures. Therefore, 3938 vertebral
bodies were potentially at risk to undergo incidental frac-
ture. Of these 3938 vertebral bodies, 745 (19%) were
adjacent to pretreated prevalent fractures, while 3193 ver-
tebral bodies (81%) were distant.
During our follow-up period, 52 of 316 patients (16.4%)
returned with 69 symptomatic incidental fractures. All 69
fractures were successfully treated by repeated VTP. If we
exclude the 7 sandwich fractures, which are addressed sep-
arately (see below), 62 of the 3938 possible vertebral bodies
(1.6%) suffered from incidental VCF during follow-up.
Anatomical Distribution
The anatomical distribution of prevalent and incidental
VCFs resembles the typical predominance within the tho-
racolumbar spine. There was no statistically significant
difference in the anatomical distribution of prevalent
versus incidental VCFs (p = 0.24, v2 test). Incidental
VCFs were adjacent in 35 of 69 (51%) versus distant to
prevalent in 34 of 69 (49%) cases, with no statistically
significant difference. However, taking into account the
total number of vertebrae after VTP (745 adjacent versus
3193 distant vertebrae), an incidence of 4.7% (35 of 745)
for adjacent versus 1.1% (34 of 3193) for distant incidental
VCFs was calculated within the follow-up period
(p \ 0.001).
Of the total 69 incidental VCFs, fractures below
occurred more often than fractures above prevalent VCFs
(35 of 69 versus 27 of 69); this trend, however, did not
reach statistical significance (p = 0.31, v2 test). The
remaining 7 of 69 incidental fractures (10%) were found in
between two pretreated levels and were therefore classified
Table 2 Number of patients and number of levels treated for
prevalent vertebral compression fracture (VCF)
No. pts
Total 316
No. prevalent VCFs
1 183
2 94
3 26
4 8
5 1
1180 J. Hierholzer et al.: Incidence of Symptomatic Vertebral Fractures in Patients After Percutaneous Vertebroplasty
123
as sandwich fractures. In the 316 patients, a total of 65
sandwich levels were generated in 65 patients (i.e., two
levels treated, with one untreated level in between). Of
these 65 individuals 7 patients (11%) suffered from sand-
wich-body fractures during follow-up.
Analyzing the distribution of prevalent and incidental
VCFs within clusters, we found the majority of fractures to
occur in cluster 3 (Table 3); this was statistically signifi-
cant for prevalent (p\ 0.02) as well as for incidental
(p \ 0.05, v2 test) VCFs over the other clusters. However,
we did not find a statistically significant difference in the
fracture localization in clusters between prevalent and
incidental fractures (p = 0.22; Table 3).
Time Interval Between Prevalent and Incidental
Fractures
The time interval between prevalent and incidental frac-
tures ranged from 7 to 1165 days (mean, 223 days; median,
70 days; SD, 311 days). Seventy-five percent of incidental
fractures (52 of 69) occurred within the first 6 months after
initial treatment. Two hundred sixty-four of the 316
patients had a postoperative follow-up of exactly 1 year at
the time of this analysis. Of these 264 patients, 33 patients
(12.5%) experienced 35 incidental fractures. Adjacent
incidental fractures occurred earlier compared to distant
incidental fractures; however, the difference trended
toward, but did not reach statistical significance (p = 0.06,
logrank Mantel-Cox analysis; Table 4). Incidental VCFs
below prevalent fracture sites occurred significantly earlier
compared to incidental VCFs above and compared to
sandwich bodies (p = 0.01). Sandwich fractures did not
occur significantly earlier or later compared to other
adjacent or distant incidental VCFs (p = 0.34 and
p = 0.19; Table 5).
Discussion
Vertebral fractures are the most common of all osteopo-
rotic fractures, and are often considered a serious and
irreversible local complication of a systemic disease.
Existing fractures are strong and independent predictors of
future vertebral fractures in untreated as well as in treated
patients with osteoporosis [16].
Percutaneous vertebroplasty (VTP) was first described
by Deramond et al. in 1987 and has been established to
treat painful vertebral compression fractures secondary to
osteoporosis or tumor [5]. The complication rate associated
with VTP is reported to be 1–3% [17] and includes
embolism, cement extravasation with subsequent neuro-
logic disorders, and allergic reactions [8]. In addition, some
authors have indicated that there could be an increased risk
of collapse of vertebral bodies in patients treated by VTP
[12, 17, 18]. These observations are supported by experi-
mental data of Baroud and Rohlmann, who found altered
biomechanical properties with increased intradiscoid pres-
sure after VTP, suggesting increased mechanical stress to
the endplates of adjacent vertebral bodies [19, 20].
The clinical data, however, are contradictory [21, 22].
The controversy is whether vertebroplasty facilitates or
even induces subsequent VCF or whether future VCFs are
to be considered part of the natural course of osteoporosis.
Frequency of Incidental Fractures
Several groups conducted mostly retrospective studies to
ascertain the incidence of new fractures following VTP.
Table 3 Cluster analysis of prevalent versus incidental fractures
Cluster no. Prevalent fractures % Incidental fractures %
1 (TH3–TH6) 29 6 3 4
2 (TH7–TH10) 101 21 20 29
3 (TH11–L2) 267 55 30 44
4 (L3–L5) 89 18 16 23
Total 486 100 69 100
Note: The majority of prevalent and incidental fractures occur in
cluster 3 (p \ 0.05, v2 test). No significant difference in fracture
localization in cluster was found between prevalent and incidental
fractures (p \ 0.05)
Table 4 Time interval between prevalent and incidental fractures:
days after initial treatment
Incidental
fractures
N Days,
min
Days,
max
Mean
days
Median
days
SD,
days
All 69 7 1165 223 70 311
Adjacent 34 7 1165 151 35 265
Distant 35 7 1112 293 112 339
Note: Adjacent incidental fractures occurred earlier than distant
incidental fractures; however, the difference trended toward, but did
not reach, statistical significance (p = 0.06, logrank Mantel-Cox
analysis)
Table 5 Time interval between prevalent and incidental fractures:
days after initial treatment
Incidental
fractures
N Days,
min
Days,
max
Mean
days
Median
days
SD,
days
All 69 7 1165 223 70 311
Below 35 7 632 118 61 148
Above 27 12 1165 323 112 380
Sandwich 7 28 1165 365 70 460
Note: Incidental VCFs below prevalent fracture sites occur signifi-
cantly earlier than incidental VCFs above prevalent fracture sites and
sandwich bodies (p = 0.01, logrank Mantel-Cox analysis). Sandwich
fractures did not occur significantly earlier or later compared to other
adjacent or distant incidental VCFs (p = 0.34 or p = 0.19,
respectively)
J. Hierholzer et al.: Incidence of Symptomatic Vertebral Fractures in Patients After Percutaneous Vertebroplasty 1181
123
Fracture frequencies on a patient basis vary between 8%
and 27% in these publications [9, 17, 18, 23]. Syed et al.
observed a 1-year incidence of new fractures in 22% of
individuals after vertebroplasty [9]. A 20% overall risk of
incidental fractures was reported in the Trout et al. study.
However, no data are given for the incidence of new
fractures within the first year after initial treatment. Tan-
igawa et al. reported an overall occurrence of incidental
fractures in 28 of 76 (37%) pretreated patients. The diag-
nosis, however, was based on radiological and clinical
features and included eight patients with asymptomatic
fractures; excluding these eight individuals, the incidence
of symptomatic incidental fractures was 26%.
In our population, only symptomatic fractures were
considered; this might explain the difference in fracture
rate between the two studies. Symptomatic incidental
VCFs occurred in 52 of 316 (16%) patients, with a follow-
up ranging between 7 and 1165 days (median, 70 days;
mean, 223 days). During follow-up 69 of all 3938 (1.6%)
previously untreated vertebral bodies underwent incidental
fractures.
At 1 year of treatment incidental fractures occurred in
33 of 316 patients, indicating a 12.5% incidence of new
fractures within the first year after VTP on a patient basis.
This result is in contrast with what Syed et al. observed in
their study (22% within the first year). All of our patients
are transferred to a dedicated medical specialist for treat-
ment of the underlying osteoporosis as soon as they are
discharged from our service. Following the published
guidelines for medical treatment, substantial benefit can be
expected for patients, with a significantly reduced future
fracture rate. In addition, the study design differs signifi-
cantly from ours. We considered only symptomatic
fractures for treatment and Syed et al. included also
asymptomatic but radiologically proven incidental VCFs in
their protocol. These differences in study design might
explain why in our population the 1-year fracture incidence
was lower than in the Syed et al. study [9].
The observed fracture rate for incidental VCF within
1 year after prevalent VCF must be discussed in light of the
data published by Lindsay et al., where a large study
population of postmenopausal women was randomized to a
placebo group during medical treatment of osteoporosis. In
this group, the overall incidence of new vertebral fractures
within 1 year of an initial vertebral fracture was 20%,
again on a patient basis. Looking at the subgroups defined,
besides a low bone mineral density (BMD), the number of
preexisting fractures (i.e., prevalent fractures) had a sig-
nificant impact on future fractures, ranging from 4% (no
preexisting fractures) to 19% for one and, finally, 24% for
two or more preexisting fractures within 1 year following
the first VCF [3]. Again, the fracture rate in our population
was lower than expected, especially in light of the
substantial number of patients with more than one pre-
valent VCF (129 of 316 patients).
The first results of the ongoing VERTOS study, which
compares conservative medical treatment with vertebropl-
asty in patients with painful osteoporotic VCF in a
prospective nonrandomized trial, indicate that the biggest
benefit for the patient is found within the first weeks after
VCF [24]. This is in accordance with the clinical experi-
ence that the majority of osteoporotic VCFs eventually heal
even without interventional treatment. Therefore, clinical
benefit must be expected to be greatest in the early phase
after symptoms commence.
The issue of increased risk of incidental fractures after
cement leakage into the discoid space during VTP has been
raised by Komemushi [10]. However, in our study these
data were not collected and therefore cannot be compared.
Location of Incidental Fractures
In our study, distant VCFs occurred in 1.1%, adjacent VCFs
in 4.7%, and sandwich -fractures in 11% of all possible
distant, adjacent, or sandwich bodies, respectively. These
data suggest a higher fracture risk for adjacent versus dis-
tant vertebrae and might suggest a higher susceptibility to
future fractures induced by percutaneous vertebroplasty.
This issue has been subject to debate in the literature [9, 23].
It is well known that osteoporotic VCFs occur with
varying frequencies in different parts of the spine, with a
marked propensity within the midthoracic and thoraco-
lumbar spine [16]. Following the concept of anatomical
clustering of osteoporotic VCFs, it seems predictable that if
the prevalent fractures occur within the thoracolumbar
spine, incidental fractures occur at an increased probability
within the same cluster. In other words, vertebral bodies in
the vicinity of pretreated levels, especially within the tho-
racolumbar spine, carry an inherent increased risk for
future fractures compared to vertebral bodies in distant
areas. Infact, Lunt et al. reported a significantly increased
risk of incidental fractures within three levels above or
below prevalent fractures compared to more than three
levels away from prevalent fractures [25].
Our data support this interpretation, showing that inci-
dental fractures occur just like prevalent fractures in
clusters. The overall higher incidence of sandwich fractures
in our group also supports this cluster-oriented risk
assessment. In fact, all sandwich fractures occurred within
the thoracolumbar junction (cluster 3, TH11–L2), which
inherently carries the highest risk for future VCF. In
addition, sandwich fractures did not occur at an earlier time
compared to the other incidental VCFs. Therefore, sand-
wich bodies undergo fracture not because the adjacent
levels have been treated by vertebroplasty, but because
they occur at the cluster of inherent highest fracture risk.
1182 J. Hierholzer et al.: Incidence of Symptomatic Vertebral Fractures in Patients After Percutaneous Vertebroplasty
123
This again could be consistent with the data of Komemushi
[10].
Interestingly, in our study 75% of incidental fractures
occurred within the first 6 months after VTP, and only 25%
in the years thereafter. This is in contrast to what we would
expect from the epidemiologic data [3]. Again, the fol-
lowing medical treatment of osteoporosis could protect
patients against additional VCFs. In fact, our data could
suggest that VTP in combination with adequate medical
treatment reduces the future fracture rate.
We consider this finding as a possible indicator of
decreased fracture susceptibility in patients after VTP.
However, this interpretation is provocative and needs fur-
ther confirmation in future studies.
Conclusion
In conclusion, from the data reported in the literature and
from our data, it cannot be concluded that the incidence of
new VCF is increased after VTP. Given our data, specu-
lation might arise that in fact the fracture incidence is lower
than would be expected from the epidemiologic data,
suggesting a protective effect against future fractures by
the combination of medical treatment and VTP.
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