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1.  Risk factors predicting the new symptomatic vertebral compression fractures after percutaneous vertebroplasty or kyphoplasty 
European Spine Journal  2011;21(5):905-911.
Introduction
Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are effective procedures to alleviate pain caused by osteoporotic vertebral compression fractures (VCFs). New vertebral compression fracture (NVCF) has been noted as a potential late sequela of the procedures. The incidence of NVCFs and affecting risk factors were investigated.
Materials and methods
The authors retrospectively analyzed the occurrence of NVCFs in 147 patients treated with PVP or PKP for osteoporotic VCFs. Possible risk factors, such as age, gender, body mass index, bone mineral density (BMD), location of treated vertebra, treatment modality, amount of bone cement injected, anterior–posterior ratio of the fractured vertebra, cement leakage into the disc space, and pattern of cement distribution, were assessed.
Results
Twenty-seven patients (18.4%) had subsequent symptomatic NVCFs with a median time to new fracture was of 70 days. The 1-year symptomatic fracture-free rate was 85.0% by the Kaplan–Meier estimate. Eighteen (66.7%) of the 27 patients had an NVCF on the adjacent vertebra. Significant differences (P < 0.05) were found between the NVCF and control groups in regard to age, treatment modality, BMD, and the proportion of cement leakage into the disc space. Discal cement leakage and low BMD affected on adjacent NVCFs.
Conclusion
The most important risk factors affecting NVCFs were osteoporosis and intervertebral discal cement leakage.
doi:10.1007/s00586-011-2099-5
PMCID: PMC3337901  PMID: 22160212
Osteoporotic compression fracture; Vertebroplasty; Kyphoplasty; BMD; Discal leakage
2.  Vertebroplasty for osteoporotic spine fracture: prevention and treatment 
European Spine Journal  2003;12(Suppl 2):S155-S162.
There is a relatively high prevalence of osteoporotic vertebral compression fractures (VCFs) in the elderly population, especially in women aged 50 or older. The result of these VCFs is increased morbidity and mortality in the short and long term. Medical treatment of these fractures includes bed rest, orthotics, analgesic medication and time. Percutaneous vertebroplasty (PVP) consists of percutaneous injection of biomaterial, such as methylmethacrylate, into the VCF to produce stability and pain relief. Biomechanical testing has shown that PVP can restore strength and stiffness of the vertebral body to the pre-fracture levels. Clinical results show immediate and maintained pain relief in 70–95% of the patients. Possible major complications include cement leakage into the spinal canal or into the venous system. Additionally, percutaneous vertebroplasty may alter the normal loading behavior of the adjacent vertebral body, and there is an increased risk of adjacent segment VCF. Kyphoplasty is a new technique, which introduces a balloon into the vertebral body transpedicularly to reduce the VCF while creating a cavity for the cement injection. This technique has the benefit of kyphosis reduction as well as less cement leakage. Research continues into the development of injectable biomaterials that are resorbable and allow for new bone formation. Vertebroplasty and kyphoplasty are safe and effective in the treatment of osteoporotic VCFs. They may allow for a faster return to function, and thus avoid the morbidity associated with medical treatment.
doi:10.1007/s00586-003-0607-y
PMCID: PMC3591824  PMID: 14505122
Vertebral compression fracture; Osteoporotic compression fracture; Percutaneous vertebroplasty; Vertebroplasty; Kyphoplasty
3.  Extreme Multi-Level Percutaneous Vertebroplasty for Newly Developed Multiple Adjacent Compression Fractures 
Osteoporotic patients who undergo percutaneous vertebroplasty (PVP) have the risk of a repeated collapse of their adjacent vertebral body due to alteration of load transfer into the adjacent vertebral body. The authors have experienced a rare case of repeated osteoporotic vertebral compression fractures (VCF) resulting in extreme multi-level PVP. A 74-year-old female developed severe back pain after slipping down one month ago. Her X-ray and MR images indicated a T11 VCF. She underwent successful PVP with polymethylmethacrylate (PMMA). Two weeks later, she returned to our hospital due to a similar back pain. Repeated X-ray and MR images showed an adjacent VCF on T12. A retrial of PVP was performed on T12, which provided immediate pain relief. Since then, repeated collapses of the vertebral body occurred 12 times in 13 levels within a 24-month period. Each time the woman was admitted to our hospital, she was diagnosed of newly developed VCFs and underwent repeated PVPs with PMMA, which finally eased back pain. Based on our experience with this patient, repeated multiple PVP is not dangerous because its few and minor complications. Therefore, repeated PVP can serve as an effective treatment modality for extreme-multi level VCFs.
doi:10.3340/jkns.2009.45.6.378
PMCID: PMC2711237  PMID: 19609423
Percutaneous vertebroplasty; Extreme multi-level vertebropklasty compression fracture
4.  Histological evaluation of bone biopsy results during PVP or PKP of vertebral compression fractures 
Oncology Letters  2012;5(1):135-138.
Percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP) is utilized for the treatment of vertebral compression fractures (VCFs). The present study was conducted to evaluate biopsy results obtained from VCFs during PVP or PKP. Between January 2003 and December 2011, 692 vertebral body biopsies were obtained from 546 patients (442 females and 104 males; mean age, 72.3 years), who underwent PVP or PKP for treatment of VCFs. A history of malignancy was identified in 44 patients. Histological/immunohistochemical evaluations were performed by experienced pathologists and 89.9% of biopsies obtained from 546 patients were suitable for histological/immunohistochemical evaluation. The biopsy results of 398 patients were in good agreement with the diagnosis of osteoporotic VCFs. Among the 44 patients with a history of malignancy, malignancy was identified in 25 patients, while osteoporosis was identified in 16 patients. Biopsies of the other 3 patients were not suitable for pathological examination. There were only 2 patients with previously undiagnosed malignancy. One patient was diagnosed with multiple myeloma, while another patient was diagnosed with metastatic carcinoma. In the present study, the rate of unsuspected malignancy was 0.4%. No symptomatic complications occurred as a result of biopsy. The results indicate that biopsy is safely performed during PVP or PKP and it is an efficacious procedure that verifies the pathological process and assists in identifying previously unsuspected processes responsible for VCFs. We recommend obtaining the biopsy of every collapsed vertebral body during PVP or PKP procedures.
doi:10.3892/ol.2012.944
PMCID: PMC3525491  PMID: 23255908
vertebral compression fractures; percutaneous vertebroplasty; percutaneous kyphoplasty; biopsy
5.  The effectiveness and safety of vertebroplasty for osteoporotic vertebral compression fractures. A double blind, prospective, randomized, controlled study 
Background: Vertebral compression fractures (VCFs) constitute a major health care problem in western countries. Several treatments modalities are available to relieve pain and allow increased activities. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure to manage patients with these fractures. The aim of this study is to evaluate the efficacy and safety of percutaneous vertebroplasty compared with standard conservative care.
Methods/Designs: In this double blind, prospective, randomized, controlled study the short- (3 months), medium- (6 months) and long-term (24 months) efficacy and safety of vertebroplasty to alleviate pain and improve function for painful osteoporotic vertebral fractures will be compared to standard conservative therapy. Conservative care will consist of 3 weeks of bed rest, wearing a rigid hyperextension corset, followed by 2-3 months in a Cheneau brace. In each of the two groups, patients will also receive treatment for osteoporosis according to their metabolic profile. Two hundred patients with painful osteoporotic vertebral compression fractures will be recruited over a 3 year period according to inclusion and exclusion criteria. We will randomly assign participants to receive either vertebroplasty or conservative care. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life questionnaires at baseline and at post-randomization time points (1, 3, 6, 12 and 24 months). Each patient will be evaluated for pre-operative MRI, and pre- and post-operative radiographs; all scans will be evaluated independently by 2 orthopaedic surgeons. Laboratory tests to assess their metabolic bone profile will be also performed. Our primary outcome will be change from baseline to 1, 3, 6, 12 and 24 months in the VAS score between the 2 groups.
Discussion: To date, vertebroplasty has been not been compared with standard conservative care for the management of patients with painful osteoporotic vertebral fractures in a randomised controlled trial. Therefore, the results of this study will allow to draw firm conclusions on this controversial topic.
PMCID: PMC3004456  PMID: 22460014
: vertebroplasty, cementoplasty, osteoporosis, vertebral compression fractures, osteoporotic fractures.
6.  Current status of percutaneous vertebroplasty and percutaneous kyphoplasty – a review 
Percutaneous vertebroplasty (PV) and kyphoplasty (PK) are the 2 vertebral augmentation procedures that have emerged as minimally invasive surgical options to treat painful vertebral compression fractures (VCF) during the last 2 decades. VCF may either be osteoporotic or tumor-associated. Two hundred million women are affected by osteoporosis globally. Vertebral fracture may result in acute pain around the fracture site, loss of vertebral height due to vertebral collapse, spinal instability, and kyphotic deformity. The main goal of the PV and PK procedures is to give immediate pain relief to patients and restore the vertebral height lost due to fracture. In percutaneous vertebroplasty, bone cement is injected through a minimal incision into the fractured site. Kyphoplasty involves insertion of a balloon into the fractured site, followed by inflation-deflation to create a cavity into which the filler material is injected, and the balloon is taken out prior to cement injection. This literature review presents a qualitative overview on the current status of vertebral augmentation procedures, especially PV and PK, and compares the efficacy and safety of these 2 procedures. The review consists of a brief history of the development of these 2 techniques, a discussion on the current research on the bone cement, clinical outcome of the 2 procedures, and it also sheds light on ongoing and future research to maximize the efficacy and safety of vertebral augmentation procedures.
doi:10.12659/MSM.889479
PMCID: PMC3795017  PMID: 24097261
vertebroplasty; kyphoplasty; bone cement
7.  Renal cement embolism during percutaneous vertebroplasty 
European Spine Journal  2005;15(Suppl 5):590-594.
Percutaneous vertebroplasty (PVP) is an effective treatment for lesions of the vertebral body that involves a percutaneous injection of polymethylmethacrylate (PMMA). Although PVP is considered to be minimally invasive, complications can occur during the procedure. We encountered a renal embolism of PMMA in a 57-year-old man that occurred during PVP. This rare case of PMMA leakage occurred outside of the anterior cortical fracture site of the L1 vertebral body, and multiple tubular bone cements migrated to the course of the renal vessels via the valveless collateral venous network surrounding the L1 body. Although the authors could not explain the exact cause of the renal cement embolism, we believe that physicians should be aware of the fracture pattern, anatomy of the vertebral venous system, and careful fluoroscopic monitoring to minimize the risks during the PVP.
doi:10.1007/s00586-005-0037-0
PMCID: PMC1602188  PMID: 16362386
Percutaneous vertebroplasty; Bone cement; Embolism; Vertebral venous system
8.  Renal cement embolism during percutaneous vertebroplasty 
European Spine Journal  2005;15(Suppl 17):590-594.
Percutaneous vertebroplasty (PVP) is an effective treatment for lesions of the vertebral body that involves a percutaneous injection of polymethylmethacrylate (PMMA). Although PVP is considered to be minimally invasive, complications can occur during the procedure. We encountered a renal embolism of PMMA in a 57-year-old man that occurred during PVP. This rare case of PMMA leakage occurred outside of the anterior cortical fracture site of the L1 vertebral body, and multiple tubular bone cements migrated to the course of the renal vessels via the valveless collateral venous network surrounding the L1 body. Although the authors could not explain the exact cause of the renal cement embolism, we believe that physicians should be aware of the fracture pattern, anatomy of the vertebral venous system, and careful fluoroscopic monitoring to minimize the risks during the PVP.
doi:10.1007/s00586-005-0037-0
PMCID: PMC1602188  PMID: 16362386
Percutaneous vertebroplasty; Bone cement; Embolism; Vertebral venous system
9.  Preliminary Results for the Treatment of a Pain-Causing Osteoporotic Vertebral Compression Fracture with a Sky Bone Expander 
Korean Journal of Radiology  2008;9(5):420-425.
Objective
Vertebral compression fractures (VCFs) are common complications of osteoporosis. The expansion of VCFs with a Sky Bone Expander is a new procedure which improves kyphotic deformities and decreases pain associated with VCFs. The purpose of this study was to investigate the preliminary results for the treatment of painful osteoporotic VCFs with a Sky Bone Expander.
Materials and Methods
Twenty-six patients with pain-causing VCFs were treated with a Sky Bone Expander. This operation involved the percutaneous insertion of the Sky Bone Expander into a fractured vertebral body transpedicularly. Following the expansion, the Sky Bone Expander was contracted and removed, resulting in a cavity to be filled with bone cement. All fractures were analyzed for improvement in sagittal alignment. Clinical complications, pain relief and ambulation status were evaluated 1 day, 1 week, 1 month, and 3 months after the operation.
Results
Twenty-four hours after the operation, all the patients treated experienced some degree of pain relief. In addition, no postoperative neurologic complications were noted. The average operative time was 42.4 ± 15.5 min per vertebra. Moreover, an average cement volume of 3.5 mL (range, 2.5 ± 5.0 mL) was injected per vertebra. The average anterior height was 18.4 ± 5.1 mm preoperatively and 20.5 ± 5.3 mm postoperatively (p < 0.01). Furthermore, the average midline height was 15.5 ± 5.2 mm preoperatively and 18.9 ± 4.0 mm postoperatively (p < 0.01). The Cobb angle improved from 18.5 ± 8.2 degrees preoperatively to 9.2 ± 4.0 degrees postoperatively (p < 0.01). The Visual Anabog Scale scores decreased from 7.7 ± 1.8 points preoperatively to 3.1 ± 2.0, 2.9 ± 1.7, 2.6 ± 1.5 and 2.9 ± 11.3 after 1 day, 1 week, 1 month and 3 months after the operation, respectively. Cement extrusion was observed in four patients without any neurologic symptoms.
Conclusion
As a result of this study, we can postulate that the expansion of compressed vetrebra with a Sky Bone Expander is a safe and minimally invasive procedure resulting in the restoration of vertebral body height and the relief of pain associated with VCFs.
doi:10.3348/kjr.2008.9.5.420
PMCID: PMC2627204  PMID: 18838851
Osteoporosis; Vertebral compression fracture; Kyphoplasty
10.  Transpedicle body augmenter in painful osteoporotic compression fractures 
European Spine Journal  2006;16(5):589-598.
Osteoporotic compression fractures (VCFs) can result in progressive kyphosis and chronic pain. Polymethylmethacrylate has been used for augmentation of VCFs; however, there are cement complications, and long-term fracture healing is unknown. The transpedicle body augmenter (TpBA), a porous titanium spacer, has been reported as an internal support to reconstruct the vertebral body combining short segment fixation in burst fracture. We retrospectively reviewed radiographic and clinical results of TpBA vertebroplasty for single symptomatic VCF in 80 patients. Manual reduction and TpBA vertebroplasty via a paramedian incision with blunt dissection was done. Mean age was 72.3 years (range 51–87 years), and female–male ratio was 66:14. The mean symptom duration was 5 months, and follow-up 44 months. Peri-operative variables and radiographic and clinical results were evaluated. The average operation time was 26.1 min, blood loss 92 cc, and hospitalization 2.3 days. No patient had neurological deterioration. TpBA was found sinking into vertebral body initially, then locked by residual cortex, and finally stabilized within the vertebra. There was no dislodgement of TpBA in the final visit. Sixty-two patients (77.5%) could walk within 3–6 h after operation and the others within 24 h. The anterior vertebral restoration was 8.0 mm initially and 6.1 mm at final follow-up. Wedge angle correction was 11.5° initially and 9.4° at final follow-up. Pain, by the visual analog scale, was 8.6 pre-operatively, 2.5 at day 7 follow-up, and 2.9 at final follow-up. By the questionnaire, 72 of 76 respondents reported a decrease in discomfort after TpBA vertebroplasty, and 63 of 76 patients reported a return to normal activity after operation. The final satisfaction rate was 93.4%. TpBA vertebroplasty led to early and medium-term clinical improvement and anatomic restoration of painful VCFs.
doi:10.1007/s00586-006-0197-6
PMCID: PMC2213539  PMID: 16957946
Osteoporosis; Vertebral compression fracture; Vertebroplasty; TpBA; Manual reduction
11.  Is There Really No Benefit of Vertebroplasty for Osteoporotic Vertebral Fractures? A Meta-analysis 
Background
Osteoporotic vertebral compressed fractures (VCFs) are the most common osteoporotic fractures. Although percutaneous vertebroplasty (PVP) reportedly relieves pain and improves function, a recent pooled analysis from two multicenter randomized controlled trials concluded the improvement in pain and disability treated with PVP was similar to those with sham surgery.
Questions/Purpose
Using meta-analysis we therefore asked whether compared with either nonoperative therapy or a sham injection for patients with VCF, PVP would (1) better relieve pain, (2) provide greater improvement in pain-related disability, and (3) increase the recurrence of vertebral fractures.
Methods
We searched PubMed, EMBASE, Medline, and the Cochrane library using the keywords “vertebroplasty AND osteoporosis OR fracture”. We included nine of the 469 articles identified. Using a random effects model, we calculated the weighted mean differences to evaluate the pain reduction at different times as the primary outcome. Pain-related disability was assessed by a quality of life (QOL) measure. Improvement of QOL and recurrence of vertebral fractures were the secondary outcomes. We used subgroup analysis to reinvestigate pain relief and function improvement of PVP based on two different controls: nonoperative therapy and sham injection. The total number of patients was 886.
Results
Pain scoring was similar between the PVP group and the sham injection group at 1 to 29 days and 90 days. However, compared with nonoperative therapy, PVP reduced pain at all times studied. QOL in the PVP group was improved or tended to be improved compared with QOL for both control groups. The risk of new fractures was similar between the PVP groups and both control groups.
Conclusions
Different control groups may have accounted for the different conclusions in the literature regarding the ability of PVP to relieve pain and restore function recovery. Compared with nonoperative treatment PVP relieved pain better and improved QOL. PVP did not increase the risk of new fractures.
Level of Evidence
Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-012-2404-6
PMCID: PMC3442000  PMID: 22729693
12.  Risk Factors of New Compression Fractures in Adjacent Vertebrae after Percutaneous Vertebroplasty 
Asian Spine Journal  2011;5(3):180-187.
Study Design
Retrospective study.
Purpose
To evaluate risk factors related to the development of new fractures in adjacent vertebrae after percutaneous vertebroplasty.
Overview of Literature
Recent reports indicate that undue numbers of new fractures in adjacent vertebral bodies occur after percutaneous vertebroplasty.
Methods
One hundred four of 369 patients who underwent percutaneous vertebroplasty were followed for over 1 year. Fifty-four patients (51.9%) subsequently suffered from adjacent vertebral fractures. Age, lumbar lordotic angle, sacral slope, pelvic tilt, pelvic incidence, bone mineral density, amounts of cement injected, the restoration of vertebral height, kyphotic angle differences preexisting fracture, and intradiscal cement leakage were noted.
Results
Average bone mineral density was -3.52 in the fracture group and -2.91 in the fracture-free group; the risk of adjacent vertebral fracture increased as bone mineral density decreased (p < 0.05). Intradiscal cement leakage occurred in 18 patients (33.3%) in the fracture group, indicating that the risk of adjacent vertebral fracture increased with intradiscal cement leakage. In addition, 36 patients (66.7%) in the fracture group had a pre-existing fracture; thus, the presence of a preexisting fracture was found to be significantly associated with an increased risk of an adjacent vertebral fracture (p < 0.05). Higher restoration rates are associated with a greater likelihood of developing adjacent vertebral fractures (p < 0.05).
Conclusions
The factors found to contribute significantly to new fractures in adjacent vertebral bodies after percutaneous vertebroplasty were a lower bone mineral density, a greater restoration rate of vertebral height, a pre-existing fracture, and intradiscal cement leakage.
doi:10.4184/asj.2011.5.3.180
PMCID: PMC3159067  PMID: 21892391
Adjacent vertebral fractures; Percutaneous vertebroplasty; Risk factors
13.  Role of the supine lateral radiograph of the spine in vertebroplasty for osteoporotic vertebral compression fracture: a prospective study 
Background
Severely collapsed vertebral compression fracture (VCF) is usually considered as a contraindication for vertebroplasty because of critically decreased vertebral height (less than one-third the original height). However, osteoporotic VCF can possess dynamic mobility with intravertebral cleft (IVC), which can be demonstrated on supine lateral radiographs (SuLR) and standing lateral radiographs (StLR). The purposes of this study were to: (1) evaluate the efficacy of SuLR to detect IVCs and assess the intravertebral mobility in VCFs, and (2) evaluate the short-term results of vertebroplasty in severely collapsed VCFs with IVCs.
Methods
We enrolled 37 patients with 40 symptomatic osteoporotic VCFs for vertebroplasty; 11 had severely collapsed VCFs with concurrent IVCs detected on the SuLR, the others had not-severely collapsed VCFs. A preoperative StLR, SuLR, magnetic resonance imaging (MRI), and postoperative StLR were taken from all patients. Radiographs were digitized to calculate vertebral body morphometrics including vertebral height ratio and Cobb's kyphotic angle. The intensity of the patient's pain was assessed by the visual analogue scale (VAS) on the day before operation and 1 day, 1 month, and 4 months after operation. The patient's VAS scores and image measurement results were assessed with the paired t-test and Pearson correlation tests; Mann-Whitney U test was used for VAS subgroup comparison. Significance was defined as p < 0.05.
Results
IVCs in patients with not-severely collapsed VCFs were detected in 21 vertebrae (72.4%) by MRI, in 15 vertebrae (51.7%) by preoperative SuLR, and in 7 vertebrae (24.1%) by preoperative StLR. Using the MRI as a gold standard to detect IVCs, SuLR exhibit a sensitivity of 0.71 as compared to StLR that yield a sensitivity of 0.33. In patients with VCFs with IVCs detected on SuLR, the average of the postoperative restoration in vertebral height ratio was significantly higher than that in those without IVCs (17.1% vs. 6.4%). There was no statistical difference in the VAS score between severely collapsed VCFs with IVCs detected on SuLR and not-severely collapsed VCFs at any follow-up time point.
Conclusions
The SuLR efficiently detects an IVC in VCF, which indicates a better vertebral height correction after vertebroplasty compared to VCF without IVC. Before performing a costly MRI, SuLR can identify more IVCs than StLR in patients with severely collapsed VCFs, whom may become the candidates for vertebroplasty.
doi:10.1186/1471-2474-11-164
PMCID: PMC2918541  PMID: 20642815
14.  The Incidence of New Vertebral Compression Fractures in Women after Kyphoplasty and Factors Involved 
Yonsei Medical Journal  2007;48(4):645-652.
Purpose
To identify the incidence of new vertebral compression fractures in women after kyphoplasty and to analyze influential factors in these patients.
Materials and Methods
One hundred and eleven consecutive female patients with osteoporotic vertebral compression fractures (VCFs) underwent kyphoplasty at 137 levels. These patients were followed for 15.2 months postoperatively. For the survey of new vertebral compression fractures, medical records and x-rays were reviewed, and telephone interviews were conducted with all patients.
Results
During that time 20 (18%) patients developed new VCFs. The rate of occurrence of new VCFs in one year was 15.5% using a Kaplan-Meier curve. Body mass index (BMI), symptom duration and kyphoplasty level were the statistically significant factors between the patient groups both with and without new VCFs after kyphoplasty. In the comparison between the adjacent and remote new VCF groups, the adjacent new VCF group showed a larger amount of polymethyl methacrylate (PMMA) use during kyphoplasty (p < 0.05). Before kyphoplasty, 9.9% of the patients had been prescribed medication for osteoporosis, and 93.7% of the patients started or continued medication after kyphoplasty. The development of new VCFs was affected by the number of vertebrae involved in the kyphoplasty. However, the lower incidence rate (15.5%) of new compression fractures might be due to a greater percentage (93.7% in our study) of patients taking anti-osteoporotic medication before and/or after kyphoplasty.
Conclusion
When kyphoplasty is planned for the management of patients with osteoporotic VCFs, the application of a small amount of PMMA can be considered in order to lower the risk of new fractures in adjacent vertebrae. The postoperative use of anti- osteoporotic medication is recommended for the prevention of new VCFs.
doi:10.3349/ymj.2007.48.4.645
PMCID: PMC2628047  PMID: 17722237
Kyphoplasty; compression fracture; influencing factor
15.  Recompression of vertebral body after balloon kyphoplasty for osteoporotic vertebral compression fracture 
European Spine Journal  2010;19(11):1907-1912.
The purpose of this retrospective clinical study was to evaluate the factors that affect recompression of operated vertebrae after percutaneous balloon kyphoplasty (PKP) for osteoporotic vertebral compression fractures (VCFs) and assess their clinical importance. PKP has been used for VCFs with satisfactory results. Several studies about subsequent VCFs adjacent to cemented vertebrae have been reported after PKP. However, the presence and significance of recompression of operated vertebrae have not been adequately described. In total, 80 patients treated with PKP for single thoracolumbar VCFs were reviewed. The follow-up period was at least 1 year. Patients were divided into those without recompression (maintained group, n = 70) and those with recompression (recompressed group, n = 10). Plain roentgenography (preoperative, operative, and last), preoperative BMD, and preoperative MRI were checked. Age, gender, T-score in BMD, duration of symptom, compression rate (CR) of VCF, reduction rate, kyphotic angle (KA), reduction angle, intervertebral cleft (IVC), and non-PMMA-endplate-contact (NPEC) were evaluated. To evaluate the clinical results, we checked the VAS score at each follow-up period. All data were analyzed statistically. The CR for the recompressed group increased significantly after surgery and decreased at the last follow-up (p < 0.05). The last CR was not significantly different from the preoperative CR. The KA showed the same pattern. The preoperative, postoperative, and last VAS scores were significantly different from one another in both groups (p < 0.05). Between the groups, preoperative KA, postoperative KA, last KA, IVC, and NPEC were significantly different (p < 0.05). In particular, last KA, IVC, and NPEC showed highly significant differences (p < 0.001). In a correlation test for the evaluated factors, IVC (r = 0.557) and NPEC (r = 0.496) were the most significant. The presence of IVC and NPEC may play an important role in inducing recompression of treated vertebrae after PKP. Careful observation of patients with these conditions is necessary to prevent deterioration of their clinical course.
doi:10.1007/s00586-010-1479-6
PMCID: PMC2989275  PMID: 20559850
Osteoporotic vertebral compression fracture; Percutaneous kyphoplasty; Recompression; Intervertebral cleft; Non-PMMA-endplate-contact
16.  Real-time CT Fluoroscopy (CTF)-Guided Vertebroplasty in Osteoporotic Spine Fractures 
Yonsei Medical Journal  2005;46(5):635-642.
The purpose of this study was to evaluate the clinical feasibility, benefits, and limitations of CT fluoroscopy (CTF)-guided percutaneous vertebroplasty (PVP). PVP under the guidance of CTF without additional guidance by conventional C-arm fluoroscopy was performed in a total of 29 vertebral bodies in 21 patients with vertebral compression fractures. While monitoring sectional CTF images, the needle was advanced from the skin to the target vertebra. Contrast media and polymethylmethacrylate (PMMA) were injected into the target vertebra with careful monitoring of their distribution. After the procedure, an evaluation was conducted to determine whether extraosseous leakage of PMMA occurred and whether sufficient filling of PMMA had been achieved. Needle placement into the target vertebra was easily achieved with both the transpedicular and posterolateral approaches. Injection of PMMA and venous leakage of contrast media were carefully monitored in all patients, and early detection of PMMA leaking was achieved in 5 patients. Extraosseous leakage that had not been detected during the procedure was not found upon postoperative evaluation. Pain scales were significantly decreased after the procedure, and no obvious complications occurred following the procedure. CTF-guided PVP without the combined use of C-arm fluoroscopy was feasible and showed definite benefits. We believe that, in spite of some limitations, CTF-guided PVP provides an alternative technique appropriate in certain situations.
doi:10.3349/ymj.2005.46.5.635
PMCID: PMC2810568  PMID: 16259060
Compression fracture; osteoporosis; vertebroplasty; CT fluoroscopy
17.  Prospective comparison of the therapeutic effect of teriparatide with that of combined vertebroplasty with antiresorptive agents for the treatment of new-onset adjacent vertebral compression fracture after percutaneous vertebroplasty 
Osteoporosis International  2011;23(5):1613-1622.
Summary
Most post-vertebroplasty new-onset adjacent vertebral compression fractures (VCFs) occur within 2–3 months, and antiresorptive agents do not significantly reduce the risk of their occurrence. In opposite mechanism, teriparatide directly stimulates bone formation and improves bone strength and quality faster. The therapeutic effect of teriparatide is better than that of vertebroplasty combined with an antiresorptive treatment and is a potentially useful therapy for new-onset adjacent VCFs after vertebroplasty.
Introduction
Following vertebroplasty, patients are at increased risk of new-onset adjacent-level VCFs. The therapeutic effect of antiresorptive agents is too slow, and they are associated with the risk of new VCFs. Teriparatide markedly increases bone formation and strength and reduces the incidence of new-onset VCFs. This prospective cohort study compared the therapeutic effects of teriparatide with those of combined vertebroplasty and an anti-resorber for treating new-onset adjacent VCFs after vertebroplasty.
Methods
Fifty patients with adjacent VCFs were randomly assigned to two groups: teriparatide only (group A) and additional vertebroplasty combined with an antiresorptive agent (group B). Relevant clinical data of the two groups were prospectively compared.
Results
The 22 patients in group A were at higher risk of new VCFs than those in group B (22 patients); they were older and had more pre-existing fractures (p < 0.05). Patients treated with teriparatide had a significantly lower incidence of new-onset VCFs (odds ratio = 0.21; 95% confidence interval, 0.02–2.10). Teriparatide-mediated VCF reduction was 78.57%, which was markedly better than that of group B. The teriparatide group had a significant decrease in the visual analog scale and an increase in the Japanese Orthopedic Association low back pain score after 6 months of treatment (p < 0.05). The increase in lumbar spine BMD was marked in the teriparatide group (21.70% vs. 6.87%) after an 18-month treatment.
Conclusions
Treatment of post-vertebroplasty adjacent VCFs with teriparatide (no new vertebroplasty) was more effective than that of repeated vertebroplasties combined with an anti-resorber.
doi:10.1007/s00198-011-1730-y
PMCID: PMC3332357  PMID: 21769661
Adjacent vertebral fracture; Antiresorptive agent; Teriparatide; Vertebral compression fracture; Vertebroplasty; Medicine & Public Health; Gynecology; Rheumatology; Orthopedics; Endocrinology
18.  Percutaneous vertebroplasty: the radiologist’s point of view 
Introduction: Vertebral compression fractures (VCFs), usually caused by osteoporosis, is a disabling pathology associated with back pain, low quality of life and high costs.
We report a retrospective study of 852 patients who underwent Percutaneous Vertebroplasty (PVP) in our department, for treatment of refractory back pain caused by osteoporotic vertebral fractures.
Objectives: To evaluate the safety and the helpfulness of the PVP in vertebral osteoporotic fractures treatment and, particularly on durable pain reduction, mobility improvement and analgesic drugs need.
Materials and Methods: Follow-up analysis was made through a questionnaire filled by the patients before and after PVP (1-6 months), designed to measure pain, ambulation capacity, ability to perform activities of daily living (ADL) and analgesic drugs administration.
Results: A statistically significant difference between visual analogue scale (VAS) values before and after treatment has been observed. No difference between VAS values were observed at 1 and 6 months post-treatment period. The treated vertebrae number did not influence post-treatment VAS values during all the follow-up. Ambulation capacity and the ability to perform ADL have been improved following PVP. Patients also reported significant reduction in administration of medications after PVP.
Conclusions: PVP is a safe and useful procedure in painful osteoporotic VCFs treatment, able to reduce pain, improve patients mobility and decrease analgesic drugs need.
PMCID: PMC2898005  PMID: 22461290
osteoporosis, vertebral compression fractures, percutaneuos vertebroplasty.
19.  The effect of pulsed jet lavage in vertebroplasty on injection forces of PMMA bone cement: an animal study 
European Spine Journal  2009;18(12):1957-1962.
Percutaneous vertebroplasty, comprising of the injection of polymethylmethacrylate (PMMA) into vertebral bodies, is an efficient procedure to stabilize osteoporotic compression fractures as well as other weakening lesions. Besides fat embolism, cement leakage is considered to be one of the major and most severe complications during percutaneous vertebroplasty. The viscosity of the PMMA during injection plays a key role in this context. It was shown in vitro that the best way to lower the risk of cement leakage is to inject the cement at higher viscosity, which is requires high injection forces. Injection forces can be reduced by applying a newly developed lavage technique as it was shown in vitro using human cadaver vertebrae. The purpose of this study was to prove the in vitro results in an in vivo model. The investigation was incorporated in an animal study that was performed to evaluate the cardiovascular reaction on cement augmentation using the lavage technique. Injection forces were measured with instrumentation for 1 cc syringes, additionally acquiring plunger displacement. Averaged injection forces measured, ranged from 12 to 130 N and from 28 to 140 N for the lavage group and the control group, respectively. Normalized injection forces (by viscosity and injection speed) showed a trend to be lower for the lavage group in comparison to the control group (P = 0.073). In conclusion, the clinical relevance on the investigated lavage technique concerning lowering injection forces was only shown by trend in the performed animal study. However, it might well be that the effect is more pronounced for osteoporotic vertebral bodies.
doi:10.1007/s00586-009-1079-5
PMCID: PMC2899445  PMID: 19568774
Vertebroplasty; Jet lavage; Injection force; Fat embolism; Cement leakage
20.  Percutaneous Vertebroplasty for Treatment of Painful Osteoporotic Vertebral Compression Fractures 
Executive Summary
Objective of Analysis
The objective of this analysis is to examine the safety and effectiveness of percutaneous vertebroplasty for treatment of osteoporotic vertebral compression fractures (VCFs) compared with conservative treatment.
Clinical Need and Target Population
Osteoporosis and associated fractures are important health issues in ageing populations. Vertebral compression fracture secondary to osteoporosis is a cause of morbidity in older adults. VCFs can affect both genders, but are more common among elderly females and can occur as a result of a fall or a minor trauma. The fracture may occur spontaneously during a simple activity such as picking up an object or rising up from a chair. Pain originating from the fracture site frequently increases with weight bearing. It is most severe during the first few weeks and decreases with rest and inactivity.
Traditional treatment of painful VCFs includes bed rest, analgesic use, back bracing and muscle relaxants. The comorbidities associated with VCFs include deep venous thrombosis, acceleration of osteopenea, loss of height, respiratory problems and emotional problems due to chronic pain.
Percutaneous vertebroplasty is a minimally invasive surgical procedure that has gained popularity as a new treatment option in the care for these patients. The technique of vertebroplasty was initially developed in France to treat osteolytic metastasis, myeloma, and hemangioma. The indications were further expanded to painful osteoporotic VCFs and subsequently to treatment of asymptomatic VCFs.
The mechanism of pain relief, which occurs within minutes to hours after vertebroplasty, is still not known. Pain pathways in the surrounding tissue appear to be altered in response to mechanical, chemical, vascular, and thermal stimuli after the injection of the cement. It has been suggested that mechanisms other than mechanical stabilization of the fracture, such as thermal injury to the nerve endings, results in immediate pain relief.
Percutaneous Vertebroplasty
Percutaneous vertebroplasty is performed with the patient in prone position and under local or general anesthesia. The procedure involves fluoroscopic imaging to guide the injection of bone cement into the fractured vertebral body to support the fractured bone. After injection of the cement, the patient is placed in supine position for about 1 hour while the cement hardens.
Cement leakage is the most frequent complication of vertebroplasty. The leakages may remain asymptomatic or cause symptoms of nerve irritation through compression of nerve roots. There are several reports of pulmonary cement embolism (PCE) following vertebroplasty. In some cases, the PCE may remain asymptomatic. Symptomatic PCE can be recognized by their clinical signs and symptoms such as chest pain, dyspnea, tachypnea, cyanosis, coughing, hemoptysis, dizziness, and sweating.
Research Methods
Literature Search
A literature search was performed on Feb 9, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2005 to February 9, 2010.
Studies were initially reviewed by titles and abstracts. For those studies meeting the eligibility criteria, full-text articles were obtained and reviewed. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established. Data extraction was carried out by the author.
Inclusion Criteria
Study design: Randomized controlled trials (RCTs) comparing vertebroplasty with a control group or other interventions
Study population: Adult patients with osteoporotic vertebral fractures
Study sample size: Studies included 20 or more patients
English language full-reports
Published between Jan 1 2005 and Feb 9, 2010
(eligible studies identified through the Auto Alert function of the search were also included)
Exclusion Criteria
Non-randomized studies
Studies on conditions other than VCF (e.g. patients with multiple myeloma or metastatic tumors)
Studies focused on surgical techniques
Studies lacking outcome measures
Results of Evidence-Based Analysis
A systematic search yielded 168 citations. The titles and the abstracts of the citations were reviewed and full text of the identified citations was retrieved for further consideration. Upon review of the full publications and applying the inclusion and exclusion criteria, 5 RCTs were identified. Of these, two compared vertebroplasty with sham procedure, two compared vertebroplasty with conservative treatment, and one compared vertebroplasty with balloon kyphoplasty.
Randomized Controlled Trials
Recently, the results of two blinded randomized placebo-controlled trials of percutaneous vertebroplasty were reported. These trials, providing the highest quality of evidence available to date, do not support the use of vertebroplasty in patients with painful osteoporotic vertebral compression fractures. Based on the results of these trials, vertebroplasty offer no additional benefit over usual care and is not risk free.
In these trials the treatment allocation was blinded to the patients and outcome assessors. The control group received a sham procedure simulating vertebroplasty to minimize the effect of expectations and to reduce the potential for bias in self-reporting of outcomes. Both trials applied stringent exclusion criteria so that the results are generalizable to the patient populations that are candidates for vertebroplasty. In both trials vertebroplasty procedures were performed by highly skilled interventionists. Multiple valid outcome measures including pain, physical, mental, and social function were employed to test the between group differences in outcomes.
Prior to these two trials, there were two open randomized trials in which vertebroplasty was compared with conservative medical treatment. In the first randomized trial, patients were allowed to cross over to the other arm and had to be stopped after two weeks due to the high numbers of patients crossing over. The other study did not allow cross over and recently published the results of 12 months follow-up.
The following is the summary of the results of these 4 trials:
Two blinded RCTs on vertebroplasty provide the highest level of evidence available to date. Results of these two trials are supported by findings of an open randomized trial with 12 months follow-up. Blinded RCTs showed:
No significant differences in pain scores of patients who received vertebroplasty and patients who received a sham procedure as measured at 3 days, 2 weeks and 1 month in one study and at 1 week, 1 month, 3 months, and 6 months in the other.
The observed differences in pain scores between the two groups were neither statistically significant nor clinically important at any time points.
The above findings were consistent with the findings of an open RCT in which patients were followed for 12 months. This study showed that improvement in pain was similar between the two groups at 3 months and were sustained to 12 months.
In the blinded RCTs, physical, mental, and social functioning were measured at the above time points using 4-5 of the following 7 instruments: RDQ, EQ-5D, SF-36 PCS, SF-36 MCS, AQoL, QUALEFFO, SOF-ADL
There were no significant differences in any of these measures between patients who received vertebroplasty and patients who received a sham procedure at any of the above time points (with a few exceptions in favour of control intervention).
These findings were also consistent with the findings of an open RCT which demonstrated no significant between group differences in scores of ED-5Q, SF-36 PCS, SF 36 MCS, DPQ, Barthel, and MMSE which measure physical, mental, and social functioning (with a few exceptions in favour of control intervention).
One small (n=34) open RCT with a two week follow-up detected a significantly higher improvement in pain scores at 1 day after the intervention in vertebroplasty group compared with conservative treatment group. However, at 2 weeks follow-up, this difference was smaller and was not statistically significant.
Conservative treatment was associated with fewer clinically important complications
Risk of new VCFs following vertebroplasty was higher than those in conservative treatment but it requires further investigation.
PMCID: PMC3377535  PMID: 23074396
21.  The Prognostic Factors Influencing on the Therapeutic Effect of Percutaneous Vertebroplasty in Treating Osteoporotic Vertebral Compression Fractures 
Objective
This retrospective study of 215 patients with 383 symptomatic osteoporotic vertebral compression fractures (VCFs) treated by percutaneous vertebroplasty (PVP), was performed to evaluate the clinical outcomes, and to analyze the various clinical factors affecting these results.
Methods
The authors assessed the clinical outcome under the criteria such as the pain improvement, activity, requirement of analgesics, and the patient's satisfaction, and determined the relation to various peri- and intra-operative factors, and postoperative imaging findings.
Results
The outcome was determined as 84.2% in relief of pain, 72.0% in change in activity, 65.7% in analgesics use, and 84.7% of satisfaction rate. More severe focal back pain, high uptake bone scan, and the lower mean T-score were related to the better pain relief following PVP. The longer the duration between fracture and PVP, the less severe focal back pain, low uptake bone scan, and leakage of PMMA into the paravertebral space were related to the less improvement in activity. Female and low uptake bone scan showed a correlation with more analgesic use. The longer the duration between fracture and PVP, low uptake bone scan, and the higher the mean T-score were correlated with the less the patients satisfaction.
Conclusion
Our study suggests that PVP may be more effective in the acute phase of VCFs, more severe focal pain, and far advanced osteoporosis on BMD. Leakage of PMMA into the paravertebral spcae also could be affecting the surgical results.
doi:10.3340/jkns.2009.45.1.16
PMCID: PMC2640817  PMID: 19242566
Osteoporosis; Vertebral compression fracture; Vertebroplasty
22.  Clinical investigations of polymethylmethacrylate cement viscosity during vertebroplasty and related in vitro measurements 
European Spine Journal  2009;18(9):1272-1278.
Percutaneous vertebroplasty, comprising an injection of polymethylmethacrylate (PMMA) into vertebral bodies, is a practical procedure for the stabilization of osteoporotic compression fractures as well as other weakening lesions. Cement leakage is considered to be one of the major and most severe complications during percutaneous vertebroplasty. The viscosity of the material plays a key role in this context. In order to enhance the safety for the patient, a rheometer system was developed to measure the cement viscosity intraoperatively. For this development, it is of great importance to know the proper viscosity to start the procedure determined by experienced surgeons and the relation between the time period when different injection devices are used and the cement viscosity. The purpose of the study was to investigate the viscosity ranges for different injection systems during conventional vertebroplasty. Clinically observed viscosity values and related time periods showed high scattering. In order to get a better understanding of the clinical observations, cement viscosity during hardening at different ambient temperatures and by simulation of the body temperature was investigated in vitro. It could be concluded, that the direct viscosity assessment with a rheometer during vertebroplasty can help clinicians to define a lower threshold viscosity and thereby decrease the risk of leakage and make adjustments to their injection technique in real time. Secondly, the acceleration in hardening of PMMA-based cements at body temperature can be useful in minimizing leakages by addressing them with a short injection break.
doi:10.1007/s00586-009-1037-2
PMCID: PMC2899546  PMID: 19479285
Vertebroplasty; PMMA cement; Injection cement viscosity; Intra-operative investigation
23.  Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients 
Background
Minimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation.
Methods
Forty-two vertebral fractures were identified in 26 consecutive patients (mean age 74 ± 9 years). All patients were treated with a novel percutaneous vertebral augmentation device (Kiva® VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA). Indications for surgery included recent (≤ 3 months) symptomatic osteoporotic vertebral fracture (n = 34) and pathologic vertebral fractures (e.g. metabolic bone disease, myeloma, metastasis) (n = 8) located between T10 and S1. Patient outcomes were evaluated pre-treatment and at 2- and 6-month follow-up visits. Postoperative cement extravasation was assessed with computed tomography. Patient-reported back pain was quantified using an 11-point numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index on a 0 to 100% scale.
Results
No cases of intraoperative hypotension, respiratory disturbance, neurological deterioration, infection, or death were observed. There were 2 (4.8%) levels where anterior cement leakage was visible radiographically in patients with osteolyses. No intracanal leakage was observed. Back pain scores improved 71% (p < 0.001) from pre-treatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001).
Conclusions
The initial clinical experience with the Kiva® System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.
doi:10.1186/1471-2474-12-206
PMCID: PMC3189204  PMID: 21939548
Fracture; Minimally invasive; Osteoporosis; Vertebral augmentation
24.  Related Biological Research in the Interface between Bone Cement and Bone after Percutaneous Vertebroplasty 
Percutaneous vertebroplasty (PVP) is widely used in the treatment of painful osteoporotic vertebral compression fractures with the injection of PMMA cement, and the controversy for PMMA damage to the osteoporotic bone tissue and to affect the fractures repairing never stops. 72 old female rabbits, each age 3.0~3.5 y, rabbits were assigned randomly to two groups of thirty-six each; PMMA cement were injected into vertebral body in rabbits via mimic PVP, sacrificed at 1 h, 24 h, 3 d, 7 d, 4 w, and 12 w. The expression VEGF and collagen type I, the tissue response, and repair reaction in the interface between PMMA and bone tissue were observed dynamically with RT-PCR and western blot technique; the osteocalcin expression were studied by immunohistochemistry. Compared with the control group, the expression of collagen I increased at 1 hour and was higher from 24 h to 3 d. From 4 weeks to 12 weeks after injection of PMMA. The expression of VEGF decreased at 1 hour and 24 hours, significantly increased at 3 days, decreased once again at 7 days, then increased significantly at 4–12 weeks. The osteocalcin expression continued to increase during 4 to 12 week. PMMA would not cause local bone permanent necrosis, and interface injury repairing cycle could be prolonged in a vertebroplasty.
doi:10.1155/2013/109784
PMCID: PMC3814054  PMID: 24222763
25.  Are Non-contrast MR Images enough for Detection of Fracture Levels Prior to Percutaneous Vertebroplasty in Patients with Osteoporosis? 
Interventional Neuroradiology  2009;14(Suppl 2):79-84.
Summary
We evaluated the detectability of painful vertebral compression fractures (VCFs) on different MRI protocols in 40 osteoporotic patients with thoraco-lumbar osteoporotic vertebral fractures. Five hundred and ten thoracic and lumbar vertebrae in 40 patients were evaluated. All patients underwent percutaneous vertebroplasty. Vertebral fractures were found in 126 (24.7%) of 510 vertebrae. Healed vertebral fractures were found in 33 (26.2%) of 126 vertebral fractures. Painful osteoporotic VCFs was found in 93 (73.8%) of 126 fractures. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of contrast-enhanced MR images, and the non-contrasted combined protocol (including T1-weighted, T2-weighted and STIR images) for the detection of painful osteoporotic VCFs were all more than 90%. Therefore, the non-contrasted combined protocol can be used for detection of painful osteoporotic VCFs prior to percutaneous vertebroplasty, unless there are conditions where contrast-enhanced MR is needed to rule out other causes of VCFs.
PMCID: PMC3328072  PMID: 20557805
painful osteoporotic vertebral compression fracture, percutaneous vertebroplasty, bone marrow edema, intravertebral cleft

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