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Journal of Clinical Neuroscience 17 (2010) 219–224
Contents lists available at ScienceDirect Journal of Clinical Neuroscience journal homepage: www.elsevier.com/locate/jocn
Clinical Study
Clinical and radiographic results of balloon kyphoplasty for treatment of vertebral body metastases and multiple myelomas
Sedat Dalbayrak a, Mehmet Reßsid Önen a, Mesut Yılmaz a, Sait Naderi b,* a Department of Neurosurgery, Lutfu Kirdar Teaching and Research Hospital, Istanbul, Turkey
b Department of Neurosurgery, Umraniye Teaching and Research Hospital, 1 Adem Yavuz Cd, Umraniye, 34766 Istanbul, Turkey
article info
Article history:
Received 13 January 2009 Accepted 23 April 2009
Keywords:
Kyphoplasty Metastasis Multiple myeloma Tumor
abstract
Kyphoplasty is a minimally invasive procedure that is used to augment vertebral body strength. This technique has been commonly used to treat osteoporotic, vertebral body compression fractures. The technique was also used to augment painful metastatic vertebral fractures. The objective of this study was to review the clinical and radiological results after kyphoplasty in patients with vertebral body com- pression fractures due to spinal metastasis and multiple myeloma and to determine factors that may affect outcome. Thirty-one patients had 41 vertebral body fractures secondary to spinal metastasis or multiple myeloma. A kyphoplasty procedure was performed on 39 levels. The pain and neurological sta- tus were evaluated using the visual analogue scale (VAS) score and the American Spinal Injury Associa- tion classification scale scores, respectively. Radiological evaluations were used to measure vertebral body height loss (VBHL) and the segmental kyphosis angle before and after surgery. The major symptoms that patients presented with included pain (25 patients); and neurological deficit (four patients). Two patients presented with no symptoms because the metastases were found during cancer screening. The mean (±standard deviation [SD]) VAS score was 7.2 ± 2.2 before surgery and 1.6 ± 1.3 after surgery. The mean preoperative VBHL was 27.8 ± 11.3% for the thoracic spine and 27.7 ± 12.5% for the lumbar spine. VBHL values were reduced to 22.4 ± 10.0% and 18.4 ± 10.4% for the thoracic and lumbar spine after surgery, respectively. The segmental kyphosis angles decreased from 21.2 ± 11.4° to 17.0 ± 9.8° for the thoracic spine and from 15.3 ± 8.8° to 10.4 ± 7.2° for the lumbar spine after surgery. There was a correla- tion between the symptom duration and VBH restoration rate. There was no correlation between the amount of injected polymethylmethacrylate and pain relief. We concluded that kyphoplasty is a safe and effective procedure for treating painful vertebral body fractures caused by metastasis and multiple myeloma. It can restore VBH and correct the kyphosis angle. While the increased amount of the injected PMMA led to its leakage, it did not contribute to restoration of the VBH or kyphosis correction. Therefore, one should avoid injection of excessive amounts of PMMA.
1. Introduction
One-third of all cancer patients develop spinal metastases,1 of which 70% are located in the thoracic spine, 20% in the lumbar spine and 10% in the cervical spine. In 85% of patients, the metas- tases involve the vertebral body. Multiple spinal metastases are seen in 10% to 40% of patients. Breast, lung and prostate cancer rep- resent about 50% of the primary sources for spinal metastases. The survival rate after diagnosis of spinal metastasis is high for patients with hormonally dependent cancers.1–3
Pain is the major symptom for patients with spinal metastases. Progression of a spinal metastasis may result in vertebral body compression fracture, with a risk of spinal cord compression.
* Corresponding author. Tel.: +90 216 632 18 18; fax: +90 216 6327124. E-mail address: saitnaderi@yahoo.com (S. Naderi).
0967-5868/$ - see front matter Ó 2009 Elsevier Ltd. All rights reserved. doi:10.1016/j.jocn.2009.04.007
Ó 2009 Elsevier Ltd. All rights reserved.
Conventional therapies for painful spinal metastases include bed- rest, bracing and radiation therapy. Radiotherapy may relieve pain; however, it cannot correct spinal deformity. Open surgical ap- proaches can decompress and stabilize the spine and are associ- ated with significant rates of morbidity and mortality. Vertebroplasty and kyphoplasty have been popular techniques used to relieve pain, restore the vertebral body height (VBH), and correct kyphosis.4–8
Vertebroplasty was introduced in the mid-1980s, and kyphopl- asty in the 1990s. Galibert et al. first introduced vertebroplasty using injections of a local anesthetic in 1987.9 Although verteb- roplasty was primarily used in the treatment of vertebral angioma, it has become popular for treating painful osteoporotic vertebral body compression fractures.10,11 The publication of successful application of vertebroplasty and kyphoplasty for the treatment of osteoporotic vertebral body compression fractures allowed
spine health care specialists to apply these techniques to other pathologies.11–13 Lapras et al. were the first to publish the results of vertebroplasty for painful lumbar metastatic lesions.14 Kaemm- erlen et al. later reported 80% pain relief in 20 patients in a similar study.15 Recently Fourney et al. reported 84% pain relief in cancer patients after vertebroplasty and kyphoplasty.16
The publication of reports on the effectiveness and safety of ver- tebroplasty and kyphoplasty radically changed the management of painful spinal metastases.17–20 Nevertheless, questions remain regarding the indications, techniques, biomaterials, optimum dos- age of cement, cement leakage-related complications, and factors affecting outcome.21–25
The aims of this study were: (i) to assess the safety and effec- tiveness of kyphoplasty in the management of patients with spinal tumors; (ii) to examine the radiological results of kyphoplasty; and (iii) to determine the effects of preoperative clinical and radiolog- ical parameters on postoperative outcome.
2. Materials and methods
The charts of 31 patients with spinal metastasis (41 fractures and 49 metastases) were reviewed. A kyphoplasty procedure was performed under sedoanalgesia on 39 fractures from the 31 patients.
Preoperative and postoperative clinical and radiological param- eters were reviewed (Table 1). All patients were contacted before completion of the study.
Pain severity was assessed using a visual analogue scale (VAS) score. The neurological status was evaluated using the American Spinal Injury Association (ASIA) scale.
Radiological evaluations were carried out on plain thoracic and lumbosacral radiographs and MRI. Postoperative imaging was per- formed using plain radiographs and thoracic and lumbar CT scans. The number of metastases was determined by MRI using T1- weighted, T2-weighted and diffusion MRI.
In order to detect the vertebral body height loss (VBHL), the ex- pected height of the fractured vertebra was determined. The ex- pected height of the fractured vertebra (D) was accepted as the average of the height of the vertebral bodies above (A) and below (B) the fractured vertebra:
D1⁄4ðAþBÞ=2 ð1Þ The height of the fractured vertebra (C) was then measured and the
VBHL was calculated using the following formula:
VBHL 1⁄4 ðD ? C=DÞ ? 100 ð2Þ The restoration rate of VBH was determined by:
100 ? ðpostoperative VBHL ? 100Þ=preoperative VBHL26;27 ð3Þ
The segmental kyphosis angle, the angle formed by the intersec- tion of lines parallel to the superior endplate of the upper vertebra and the inferior endplate of the lower vertebra, was determined from plain radiographs.26,27
Table 1
The studied clinical and radiological parameters in patients with vertebral body metastasis
The fracture types, vertebral body posterior wall integrity and evidence of epidural tumor extension were evaluated by MRI and CT scans. Vertebral body fractures were classified as wedge or biconcave.28
For statistical analysis using the Statistical Package for the So- cial Sciences for Windows version 16.0 software (SPSS, Chicago, IL, USA), the non-parametric test, and Wilcoxon signed rank tests were used. Significance was determined by p values 6 0.05.
3. Results
There were 17 female and 14 male patients, aged 35 to 78 years (mean: 62.0 years) who had 41 fractures: 22 patients with single level (54.8%); eight with 2 level (25.8%); and one patient with a 3 level fracture (9.6%). There were 49 levels of metastases including: single level in 19 patients (61.2%); 2 level in nine patients (29.0%), and one patient each with 3, 4 and 5 level metastases (3.2%).
The primary pathology was gastric cancer in seven patients (22.5%), breast cancer in six (19.3%), lung cancer in four (12.9%), multiple myeloma in six (19.3%), mesothelioma, lymphoma and colorectal cancer in two patients each (6.4%), and pancreatic cancer and seminoma in one patient each (3.2%).
3.1. Clinical parameters
The major symptoms observed included pain in 25 patients (80.6%) and neurological deficits in four patients (12.9%). Two pa- tients had no symptoms because their metastases were found dur- ing cancer screening. The mean symptom duration was 64.5 days (range: 30–180 days) in 29 symptomatic patients. The mean pre- operative VAS score was 7.2 ± .2 (range: 1–10).
There was no correlation between symptom duration and the VAS score (p > 0.05; Table 2), or between the preoperative VAS score and preoperative VBHL (p > 0.05; Table 3).
Complete pain relief was attained in all patients. The mean postoperative VAS score was reduced to 1.6±1.3 (range: 0–3; p < 0.001). The postoperative VAS score was 3 in nine patients (29.0%), 2 in seven patients (22.5%), 1 in five patients (16.1%) and 0 in 10 patients (32.2%).
There was a significant difference between preoperative and postoperative VAS scores (p < 0.05; Table 4).
There was a significant difference between the preoperative and postoperative VAS scores in patients with moderate preoperative pain (VAS score < 7) and severe preoperative pain (VAS score > 7; p < 0.05; Table 5).
The preoperative ASIA scale score was D in 11 patients (35.4%), and E in 20 patients (64.6%). The postoperative ASIA scale score was E in 30 patients (96.8%), and D in one patient (3.2%).
3.2. Radiological parameters
The vertebral body fractures were classified as wedge fractures at 20 levels (48.8%) and biconcave at 21 levels (51.2%).
The vertebral body posterior wall was minimally damaged at 15 levels (38.5%) and was intact at 24 levels (61.5%). Epidural exten- sion was absent from 21 levels (67.7%). Minimal spinal canal inva-
Table 2
The relationship between symptom duration and visual analogue scale (VAS) score
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Clinical parameters Radiological parameters |
Age, gender Symptomatology Symptom duration Pain severity Neurological status Number of metastases |
Symptom duration (days) Preoperative VAS (mean ± SD) |
0–60 (n = 22) 7.0 ± 2.3 >60 (n=9) 7.6±2.1 p > 0.05 |
SD = standard deviation.
Table 3
The relationship between preoperative vertebral body height loss (VBHL) and visual analogue scale (VAS) score
SD = standard deviation.
Table 4
A comparison (mean ± standard deviation) of preoperative (Pre) and postoperative (Post) visual analogue scale (VAS) scores
Table 5
A comparison (mean ± standard deviation) of postoperative (Post) visual analogue scale (VAS) scores between patients with VAS score of less than, and more than, 7
sion was seen at nine levels (29.0%), and moderate spinal canal invasion at one level (3.2%). There was no significant difference in postoperative VAS scores between patients with and without epidural tumor extension (p > 0.05; Table 6).
The mean preoperative VBHL was 27.8 ± 11.3% (range: 14–55%) in the thoracic vertebrae and 27.7 ± 12.5% (range: 5–46%) in the lumbar vertebrae. VBH was increased at 38 out of 39 levels (97.4%). The mean postoperative VBHL was 22.4 ± 10.0% (range: 4–40%) for the thoracic vertebrae and 18.4±10.4% (range: 0– 42%) for the lumbar vertebrae.
The mean VBH restoration rate was 36.7 ± 28.0% in the lumbar spine and 21.5 ± 18.9% in the thoracic spine. The restoration rate was 29.6 ± 25.0 at all levels.
The mean preoperative kyphosis angle in the thoracic and lum- bar vertebrae was measured as 21.2 ± 11.4o (range: 7–48o) and 15.3 ± 8.8o (range: 5–28o), respectively. The mean postoperative angulations of the thoracic and lumbar vertebrae were measured as 17.0 ± 9.8o (range: 5–40o), and 10.4 ± 7.2o (range: 2–22o), respectively.
Table 7 shows significant differences between preoperative and postoperative radiological parameters (p < 0.05).
Patients who had symptoms for less than 60 days had better VBH restoration rates than those with longer symptom duration (p < 0.05; Table 8).
Table 6
A comparison (mean ± standard deviation) of pain relief in patients with and without epidural tumor extension
SD = standard deviation, VAS = visual analogue scale score.
Table 7
A comparison (mean ± standard deviation) of the preoperative (Pre) and postoper- ative (Post) radiological parameters
SD = standard deviation, VBHL = vertebral body height loss.
Table 8
The relationship between symptom duration and vertebral body height (VBH) restoration rate (mean ± standard deviation)
Table 9
The relationship between preoperative (Pre) visual analogue scale (VAS) range and vertebral body height (VBH) restoration rate (mean ± standard deviation)
There was no correlation between preoperative VAS score and the VBH restoration (p > 0.05; Table 9).
In 15 patients, 5 mL of PMMA was injected, and more than 6 mL was injected in 24 patients. There was no correlation between the amount of injected PMMA and pain relief (p > 0.05; Table 10).
There was also no correlation between the amount of PMMA in- jected and VBH restoration rate, or between the amount of injected PMMA and kyphosis correction rate (p > 0.05; Table 11).
3.3. Assessment of cement leakage
Asymptomatic polymethylmethacrylate (PMMA) leakage was observed at 13 levels (33.3%). There was minimal epidural leakage at four levels (12.9%), minimal leakage into the upper interverte- bral disc at two levels (6.4%), minimal leakage into the lower inter- vertebral disc at four levels (12.9%), and leakage into the paravertebral muscles at three levels (9.6%).
There was a correlation between the amount of injected PMMA and cement leakage in the thoracic vertebrae (p < 0.05) but not with the lumbar vertebrae (p > 0.05; Table 12).
4. Discussion
The results of this study confirmed that patients with spinal metastases and myeloma can adequately tolerate kyphoplasty. Kyphoplasty provided statistically significant improvement in pain severity, vertebral body height and segmental kyphosis. The results obtained in our study are, in general, consistent with previously published studies.
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Preoperative VBHL Preoperative VAS (mean ± SD) |
0–25% (n = 7) 7.0 ± 2.3 >25% (n = 14) 7.3 ± 2.0 p > 0.05 |
Parameter Pre Post p level |
VBHL (thoracic) 27.8 ± 1.3% 27.7 ± 12.5% 27.8 ± 11.4% 21.2 ± 11.4o 15.3 ± 8.8o 18.0 ± 10.3o 21.5 ± 18.9% 36.7 ± 28.0% 22.4 ± 10.0% 18.4 ± 10.4% 20.2 ± 10.3% 17.0 ± 9.8o 10.4 ± 7.2o 13.4 ± 9.0o p<0.05 p<0.05 p<0.05 p<0.05 p<0.05 p<0.05 |
Thoracic Pre 7.0 ± 1.6 Post 1.9 ± 1.1 Lumbar Pre 7.3 ± 2.7 Post 1.4 ± 1.5 Total Pre 7.2 ± 2.2 Post 1.6 ± 1.3
p < 0.05 p < 0.05 p < 0.05
Symptom duration (days) VBH restoration rate |
0–60 (n = 22) 34.3 ± 27.0 >60 (n=9) 16.9±9.3 p < 0.05 |
VAS range Pre VAS Post VAS |
0–7 (n=13) 5.4±2.4 1.6±1.1 8–10 (n=18) 8.5±0.7 1.3±1.2 p < 0.05 |
Pre VAS range VBH restoration rate |
0–7 (n = 13) 28.1 ± 19.9 8–10 (n = 18) 25.0 ± 24.1 p > 0.05 |
Epidural tumor Preoperative VAS Postoperative VAS extension (mean ± SD) (mean ± SD) |
Absent (n=29) 7.4±2.2 Present (n = 10) 7.0 ± 1.8 p > 0.05 1.3±1.4 2.0 ± 1.1 p > 0.05 |
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Table 10
A comparison of preoperative (Pre) and postoperative (Post) pain relief by visual analogue scale (VAS) scores (mean±standard deviation) and amount of injected polymethylmethacrylate (PMMA)
PMMA (mL) Lumbar Thoracic Total |
3–5 8.7 ± 0.9 2.2 ± 1.5 6.6 ± 2.0 2.0 ± 1.2 7.7 ± 2.0 1.8 ± 1.3 p > 0.05 6–9 6.9 ± 2.9 1.2 ± 1.4 7.1 ± 1.3 1.9 ± 1.0 6.9 ± 2.3 1.6 ± 1.3 |
Table 11
A comparison of the amount of injected polymethylmethacrylate (PMMA) and vertebral body height (VBH) restoration rate (mean ± standard deviation, SD), and between the amount of PMMA injected and kyphosis correction rate (KCR) (mean ± SD)
; = decreasing, " = increasing.
Table 12
A comparison of the amount of polymethylmethacrylate (PMMA) injected and the occurence of cement leakage (no. levels)
Since the main indications for vertebroplasty and kyphoplasty include pain and vertebral body compression fractures, most stud- ies have focused on results related to these symptoms and signs.
4.1. Pain relief
Pain is a major symptom of spinal metastasis and multiple mye- loma. There is a lack of information about the relationship between pain and other symptoms and signs. This study revealed no corre- lation between pain and other signs and symptoms including symptom duration, VBHL, epidural tumor extension, and tumor progression.29,30
Pain relief has been reported to be affected by the type of dis- ease (osteoporosis vs. tumor), type of procedure (vertebroplasty vs. kyphoplasty), the extent of the tumor, and the aggressiveness of the indications (procedure use in relatively and absolutely con- traindicated patients).
The analgesic effects and complication rates of vertebroplasty and kyphoplasty have been reviewed in a small number of meta- analyses. Gill et al.31 reviewed 21 published studies including 14 vertebroplasty (91,046 patients) and seven kyphoplasty (263 pa- tients) series. They reported that the difference in early pain relief between the two treatment types was not significant. Similar re- sults were also reported by others.25,32,33 However, all these stud- ies reported that kyphoplasty produced a more positive profile of adverse events.
In general, pain relief from metastatic fractures is less than from osteoporotic fractures. Complete pain relief has been achieved in 90–100% of patients with osteoporotic fractures,24,34 and 50– 100% of patients with metastasis12,24,34,35 (Table 13). Our study re- vealed that significant pain relief was achieved in all patients.
The relationships between pain relief and epidural tumor exten- sion and between pain relief and VBH restoration have also been studied. Shimoni et al.36 reviewed the results of vertebroplasty for 50 patients with metastatic disease and multiple myeloma and
reported no differences in postoperative pain scores between pa- tients with and without spinal epidural tumor extension after the procedure. Analysis of the results of this study revealed no signifi- cant differences between postoperative VAS scores in patients with and without epidural tumor extension (p > 0.05). This study re- vealed that injecting a larger amount of PMMA tended to provide a better, but statistically insignificant, amount of pain relief (p > 0.05).
4.2. Deformity and correction
Loss of VBH in both osteoporotic and metastatic vertebral frac- tures results in kyphosis, and the resultant forward displacement of the center of gravity appears to increase the risk of subsequent vertebral fractures at adjacent levels.28,37 This study revealed mean VBHL of 27.8 ± 11.3% and 27.7 ± 12.5% for the thoracic and lumbar vertebrae, respectively. The preoperative kyphosis angles were 21.2 ± 11.4o and 15.3 ± 8.8o for the thoracic and lumbar spine, respectively. The increased degrees of VBHL and angulation for thoracic vertebrae may be due to natural thoracic kyphosis.
Kyphoplasty not only restores VBH effectively, but may also correct deformity and, subsequently, the center of gravity.16,38,39 To some extent, vertebroplasty may also restore VBH.40–42 How- ever, kyphoplasty provides better VBH restoration. Most of the height gained after kyphoplasty occurs in the midbody,38,43 and greater correction over longer regions of the spine can be achieved with multilevel kyphoplastic procedures and is proportional to the number of levels addressed.38
Height restorations of 0–90% and angular corrections of 0–18o
have been reported after vertebroplasty and kyphoplasty for
metastases and myelomas.16,27,30,43–46 These results are commonly
less satisfying than those reported for osteoporotic fractures.16,27,30,45,47,48
The lack of a standard measurement technique and the pres- ence of magnification-related errors make comparison of results
Table 13
Comparison of pain relief rate reported in the literature after vertebroplasty and kyphoplasty performed for spinal metastasis and myeloma
PMMA (mL) VBH restoration rate KCR |
3–5 (n = 15) 31.1% ± 29.1% 6–9 (n = 24) 29.0 ± 23.9% p > 0.05 3.5 ± 2.0o 4.6 ± 3.9o p > 0.05 |
PMMA (mL) Cement leakage |
Thoracic vertebrae 3–5 mL (n = 5) 0 p < 0.05 6–9mL (n=11) 8 Lumbar vertebrae 3–5 mL (n = 11) 2 p > 0.05 6–9mL (n=12) 3 |
Year Ref No. No. Pathology Procedure Pain relief patients levels (%) |
199622 37 40 29 Met + 8 MM 199656 37 52 Met 199711 37 40 29 Met + 8 MM 200316 56 97 35 Met + 21 MM 200357 32 87 24 Met + 8 MM 200359 21 27 Met 200436 50 50 36 Met + 14 MM 200658 14 19 MM Current study 31 41 25 Met + 6 MM PVP 75 PVP 73 PVP 97.3 65PVP+ 84 32 KP PVP 90 PVP 82 10KP+ 100 9 PVP |
KP = kyphoplasty, Met = metastasis, MM = multiple myeloma, PVP = percutaneous vertebroplasty.
among different series difficult. For instance, the apparent magni- tude of height restoration varied nearly four-fold, depending on the reporting method.40 Therefore, reports on improvement in VBH and kyphotic angle should be interpreted with some caution, as studies have used non-standardized radiographic measurement methods. In this study, VBHL was measured with respect to the estimated height of the involved vertebral body. Using this tech- nique, significant VBH restoration was observed (p < 0.05 for tho- racic and lumbar vertebrae).
This study also showed that there was a correlation between the preoperative symptom duration and VBHL restoration rate. Pa- tients with a symptom duration of less than 60 days showed better VBHL restoration than those with a longer duration of symptoms. Therefore, for maximal VBHL restoration, a specific kyphoplastic procedure can be recommended during the early stages of the disease.
This study failed to show a correlation between VBHL restora-
tion and other parameters such as preoperative VAS score, postop-
erative VAS score and the amount of injected PMMA. The lack of a
correlation between postoperative pain relief and VBH restoration
49,50
4.3. Cement leakage
Cement leakage is the most common complication of verteb-
roplasty and kyphoplasty. Two major causes of cement leakage
are insufficient polymerization of the PMMA cement and excessive
The lack of a correlation between the amount of injected ce- ment and postoperative pain relief, in addition to the likelihood that cement leakage was due to excessive injection of cement, sug- gests that small amounts of PMMA (<5 mL) can adequately relieve pain.
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has been reported. Based on the results presented here, it can be concluded that a good, analgesic outcome does not require injection of an excessive amount of PMMA or complete VBHL restoration.
injection of cement.51 It is well-known that cement leakage is more 11,16,24,34,48,52,53
common in vertebroplasty than in kyphoplasty.
Furthermore, the incidence of cement extravasation with kyphopl-
asty and vertebroplasty for metastatic lesions is much higher than
that associated with osteoporotic fractures. This may be attributed
to the cortical destruction associated with metastatic lesions. The
rate of cement leakage reportedly ranged between 8.6% and
10%.24 However, the rate may be even higher, at 37.5%16 in one
study and 72.5%11 in another. The rate of cement leakage in our
study was 33.3% and occurred most commonly in the thoracic ver-
tebrae (61%). This could be attributed to excessive injection of ce-
ment, particularly in the thoracic vertebrae (p < 0.05). The review
of postoperative CT scans showed that cement leakage occurred
in all areas, including the intervertebral disc, and the paravertebral
54,55
The lack of a correlation between pain relief and VBH restora- tion, or between the amount of injected PMMA and cement leakage in the thoracic vertebrae, suggest that lesser amounts of cement should be injected. The smaller size of the thoracic vertebrae indi- cates that there is less space available for cement and hence main- taining optimal intravertebral pressure is required for strength.
5. Conclusion
The results of this study indicate that kyphoplasty is an effective procedure for restoring VBH, correcting spinal deformity, and pro- viding pain relief in patients with spinal fractures secondary to metastasis and multiple myeloma. This study demonstrated better VBHL restoration in patients with symptom duration less than 60 days. We conclude that for maximal postoperative VBHL resto- ration, kyphoplasty should be performed in the early stages of the disease.
and epidural areas. This was in accordance with Mousavi et al., who reported that, for patients with osteoporotic fractures, leakage occurred mainly into the disc, whereas in metastatic lesions leaks were present in multiple locations.
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Author's personal copy
224 S. Dalbayrak et al. / Journal of Clinical Neuroscience 17 (2010) 219–224
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