Vertebroplasty Procedures Research Articles

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial

ObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.DesignRandomised, double blind, sham controlled clinical...

Ultra-early injection of low-viscosity cement in vertebroplasty procedure for treating osteoporotic vertebral compression fractures: A retrospective cohort study

ObjectiveTo evaluate the clinical effect of ultra-early injection (before the phase of “tooth-paste-like”) of low-viscosity cement in percutaneous vertebroplasty (PVP) for treating osteoporotic vertebral compression fractures (OVCFs). MethodsTwo hundred sixty-one patients who had PVP procedures with low-viscosity cement (ultra-early injection: 145, normal injection: 135) were included from July 2010 to July 2016 in our hospital. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Cobb angle, cement leakage, and adjacent vertebral fractures were evaluated. The follow-up period was over 12 months. ResultsVAS 3.0 d after surgery was significantly reduced in the ultra-early injection group compared to that in the control group (P = 0.00), but no difference was found at the final follow-up (P = 0.53). Similar results were found for ODI. The Cobb angle in both groups was recovered after PVP (P < 0.05); however, in the control group, the Cobb angle at the final follow-up was significantly increased compared with that 3.0 d after surgery (P = 0.00). There was a significant difference in the Cobb angle between the two groups at the final follow-up (P = 0.00). Regarding cement leakage, there were no significant differences in terms of mild (P = 0.58), moderate (P = 0.68), or severe leakage (P = 0.52). Seven patients in the control group had adjacent vertebral fractures, but only one patient in the ultra-early injection group experienced adjacent fractures (P = 0.03). ConclusionsUltra-early injection of low-viscosity cement during PVP procedures in the treatment of OVCFs not only quickly and significantly relieves pain, reduces the incidence of adjacent vertebral fractures, and prevents progressive kyphotic deformity, but also does not increase the risk of cement leakage when compared with that of the traditional injection procedure.

Minimally invasive percutaneous endoscopic treatment for acute pyogenic spondylodiscitis following vertebroplasty

Acute pyogenic spondylodiscitis caused by percutaneous vertebroplasty is a rare complication. We present the first report of minimally invasive endoscopic treatment for acute spondylodiscitis caused by vertebroplasty. A 60-year-old female was transferred with the symptom of right hip flexion weakness for 1day. The patient underwent a vertebroplasty procedure because of L3 osteoporotic compression fracture at other hospital 6weeks ago. Physical examination, laboratory finding and magnetic resonance imaging revealed an acute pyogenic spondylodiscitis with right L2 nerve root palsy caused by compression of bone and cement after L3 body collapse. Percutaneous endoscopic procedures including needle biopsy, debridement, root decompression and drainage were performed. One week after endoscopic treatment, her symptoms of back pain and nerve palsy improved significantly. After endoscopic treatment, the patient underwent conservative treatment with appropriate antibiotics according to the bacterial culture test results. Six weeks postoperatively, she was pain free with no neurological deficits or signs of infection. Five months later, spontaneous fusion between L2 and L3 body was observed. We report a case treated with endoscopic procedure without open surgery for acute pyogenic spondylodiscitis following vertebroplasty.

The effect of mechanical aspiration of the vertebral body on pulmonary arterial pressure before cement injection in the vertebroplasty procedure.

The aim of this study is to compare the efficacy of the mechanical aspiration technique just prior to cement application in the standard vertebroplasty (VP). Forty patients were included in the study. In group A, mechanical aspiration of the cavity was done just before the cement injection and in group B aspiration of vertebral body did not perform, VP was done with the same size cannula, same injection force, same injection speed and same cement viscosity. Pulmonary arterial pressures (PAPs) and blood d-dimer values were recorded preoperatively, 24 h and 3 days after the procedure. The PAP and d-dimer data were statistically compared with Student's t-test. The mean age was 71 (62-87) in A and 70 (64-88) in B. The augmented level was 6.7 in A and 6.9 in B. Cement leakage was present in four in A and six in B. Acute hypotension was observed immediately after cement injection in one patient in A and four patients in B. The preoperative mean PAP in A was 35mm/Hg and elevated to 48 mm/Hg on the first postoperative day and decreased to 42 mm/Hg on the third postoperative day. The mean PAP in B was 36 mm/Hg preoperatively, 71 mm/Hg on the first day, and 58 mm/Hg on the third day ( p < 0.05). The d-dimer values revealed a difference between groups, the PAP values significantly changed between before and after the operation in both groups ( p < 0.005). Aspiration of the vertebral body can easily be used to decrease the risk of cement leakage and the migration of fatty particles into the pulmonary circulation.

Percutaneous vertebroplasty: Current controversy

Percutaneous vertebroplasty: Current controversy

Utilization of vertebroplasty and kyphoplasty procedures throughout the United States over a recent decade: an analysis of the Nationwide Inpatient Sample

Given the increasing societal focus on health care utilization and value-based care, it is essential to understand the demographic and economic data surrounding percutaneous vertebral augmentation procedures performed in the United States. Double-blinded prospective randomized controlled trials have shown no benefit to the use of vertebroplasty over a sham procedure in the treatment of vertebral fractures. Contrastingly, kyphoplasty may be beneficial when appropriately indicated. The National Inpatient Sample (NIS) database was queried for patients who underwent either kyphoplasty (ICD-9-CM 81.66) or vertebroplasty (ICD-9-CM 81.65) procedures between 2006 and 2014 across 44 states. Demographic and economic data were obtained which included the annual number of surgeries, age, sex, insurance type, location, and frequency of routine discharge. The NIS database represents a 20% sample of discharges from U.S. hospitals, which is weighted to provide national estimates. In 2014, an estimated total number of 19,420 kyphoplasty and 6,130 vertebroplasty procedures were performed across the United States. The number of vertebroplasty procedures decreased 53% from 13,128 in 2008. Similarly, the number of kyphoplasty procedures decreased 17% from 23,320 in 2007. Based on payer, Medicare patients comprised 83% of those billed for kyphoplasty and vertebroplasty, and 75% of procedures were utilized in areas designated as "not low income". In 2014, patients in the South Atlantic region comprised 24% of vertebroplasty and 28% of kyphoplasty cases, far more than any other region. Additionally, kyphoplasty and vertebroplasty were more often performed in teaching facilities rather than community hospitals (60% and 67%, respectively). Since the publication of two double-blind, prospective randomized controlled trials showed no benefit of vertebroplasty over a sham procedure, there has been a significant decrease in both kyphoplasty and vertebroplasty procedures.

Vertebroplasty and interventional radiology procedures for bone metastases

Advances in cancer treatments have lengthened the survival of patients with bone metastases. Optimal control of the symptoms and prevention of the complications associated with bone metastases improve quality of life. Achieving these goals increasingly involves interventional radiology procedures. These include bone consolidation and analgesic techniques such as cementoplasty (vertebroplasty at the spine); percutaneous implantation of screws, metallic reinforcement devices, or intraosseous implants; and tumor destruction using thermal methods (radiofrequency and cryotherapy), chemicals (alcohol), and drugs (chemoembolization), which have fewer indications. Here, these techniques and their indications are reviewed.

Trends in Inpatient Vertebroplasty and Kyphoplasty Volume in the United States, 2005-2011: Assessing the Impact of Randomized Controlled Trials.

Retrospective analysis of the Nationwide Inpatient Sample, 2005-2011. To identify trends in procedural volume and rates in the time period surrounding publication of randomized controlled trials (RCTs) that examined the utility of vertebroplasty and kyphoplasty. Vertebroplasty and kyphoplasty are frequently performed for vertebral compression fractures. Several RCTs have been published with conflicting outcomes regarding pain and quality of life compared with nonsurgical management and sham procedures. Four RCTs with discordant results were published in 2009. The Nationwide Inpatient Sample provided longitudinal, retrospective data on United States' inpatients between 2005 and 2011. Inclusion was determined by a principal or secondary International Classification of Diseases, Ninth Revision, Clinical Modification code of 81.65 (percutaneous vertebroplasty) or 81.66 (percutaneous vertebral augmentation; "kyphoplasty"). No diagnoses were excluded. Years were stratified as "pre" (2005-2008) and "post" (2010-2011) in relation to the 4 RCTs published in 2009. Patient, hospital, and admission characteristics were compared using Pearson χ test. The estimated annual inpatient procedures performed decreased from 54,833 to 39,832 in the pre and post periods, respectively. The procedural rate for fractures decreased from 20.1% to 14.7% (P<0.0001). Patient and hospital demographics did not change considerably between the time periods. In the post period, weekend admissions increased (34.2% vs. 12.4%, P<0.0001), elective admissions decreased (21.4% vs. 40.0%, P<0.0001), routine discharge decreased (33.0% vs. 52.1%, P<0.0001), and encounters with ≥3 Elixhauser comorbidities increased (54.5% vs. 39.1%, P<0.0001). The absolute rate of inpatient vertebroplasty and kyphoplasty procedures for fractures decreased 5% in the period (2010-2011) following the publication of 4 RCTs in 2009. The proportion of elective admissions and routine discharges decreased, possibly indicating a population with greater disease severity. Although our analysis cannot demonstrate a cause-and-effect relationship, the decreased inpatient volume and procedural rates surrounding the publication of sentinel negative RCTs is clearly observed.

Effect of Bone Cement Volume Fraction on Adjacent Vertebral Fractures After Unilateral Percutaneous Kyphoplasty.

A retrospective study. Complications of the bone cement used in vertebroplasty and kyphoplasty procedures have received increasingly more attention, especially for bone cement volume. The aim of the study was to retrospectively assess the relationship between bone cement volume fraction and adjacent vertebral fracture (AVF) after unilateral percutaneous kyphoplasty (PKP). Between 2006 and 2011, 495 patients with single-level osteoporotic vertebral compression fracture (OVCF) were surgically treated by unilateral PKP and had completed 12-month follow-up in our hospital. According to the new OVCF, they were divided into 3 groups: AVF group, non-AVF group, and normal group (who were not new OVCF). On the basis of the value of the plain radiography, the cement volume fraction for the vertebral body was calculated, and cement leakage, bone mineral density, visual analog scale, and Cobb angle of preoperative and postoperative were analyzed. During the follow-up, 110 (22.2%) patients had new OVCF, and others were normal (n=385). Fifty-two cases were AVF and 58 were non-AVF. The cement volume fraction of AVF group, non-AVF group, and normal group were 32.5%±5.5%, 27.3%±1.8%, and 27.1%±2.6%, respectively. The 95% confidence interval of volume fraction were (31.0, 34.1), (26.8, 27.7), and (26.9, 28.5), respectively. The AVF group showed higher cement volume fraction in 3 groups (P<0.05), and there were no significant difference between non-AVF and normal group (P>0.05). There were 19 (36.5%) patients with cement leakage in AVF group, 12 (20.7%) in non-AVF group, and 68 (17.7%) in normal group. The AVF group showed higher cement leakage (P<0.05). Compared with AVF group and normal group, non-AVF group had lower bone mineral density in preoperation. All groups reported significantly improved visual analog scale scores and Cobb angle on the day of surgery. However, there were no significant difference between the 3 groups. Unilateral PKP is an effective and safe procedure for patients with OVCF. However, cement volume should be determined in terms of the vertebral body fraction to obtain a favorable outcome. The risk of AVF and cement leakage will increase obviously with the cement volume fraction increased. We recommend that a bone cement volume fraction of about one fourth is suitable for unilateral PKP.

Percutaneous Vertebroplasty Improves Pain Control and Quality of Life in Patients Suffering from Back Pain: A Single Center Experience

Background/Objectives: The purpose of this study was to assess the efficacy of pain control at a single center in a population of patients with osteoporotic fractures or vertebral metastasis after vertebroplasty (VP). Patients and Methods: We retrospectively evaluated 163 patients who underwent VP at our institution between January 2008 and March 2016. Pain was measured with the visual analogue scale (VAS). The impact of pain on the quality of life (QoL) of the patients was estimated using the modified Roland–Morris questionnaire (RMQ). The VAS and RMQ values were calculated before the VP procedure and at one month and 6 months after the treatment. Results: VAS and RMQ mean scores were 7.8, 3.9 and 3.5, and 20.7, 11.5 and 9.6 before the procedure and at the 1 month and 6 months follow-up, respectively, which showed significant improvement (P < 0.0001). A significant correlation was noticed between the VAS scores and the RMQ values at the base line (P = 0.008; r = 0.21). Conclusion: This retrospective study assessed the efficacy of VP treatment for vertebral fractures due to osteoporosis or tumor infiltration and showed significant pain relief and improved QoL.

Magnetic Resonance Enhancement Pattern as a Predictor of Cement Volume in Vertebroplasty Procedures for Osteoporotic Fractures

Magnetic Resonance Enhancement Pattern as a Predictor of Cement Volume in Vertebroplasty Procedures for Osteoporotic Fractures

Prophylactic vertebroplasty procedure applied with a resorbable bone cement can decrease the fracture risk of sandwich vertebrae: long-term evaluation of clinical outcomes.

A sandwich vertebra is formed after multiple osteoporotic vertebral fractures treated by percutaneous vertebroplasty, which has a risk of developing new fractures. The purpose of our study was to (i) investigate the occurrence of new fractures in sandwich vertebra after cement augmentation procedures and to (ii) evaluate the clinical outcomes after prophylactic vertebral reinforcement applied with resorbable bone cement.From June 2011 to 2014, we analysed 55 patients with at least one sandwich vertebrae and treated with percutaneous vertebroplasty. Eighteen patients were treated by prophylactic vertebroplasty with a resorbable bone cement to strengthen the sandwich vertebrae as the prevention group. The others were the non-prevention group. All patients were examined by spinal radiographs within 1 day, 6 months, 12 months, 24 months and thereafter.The incidence of sandwich vertebra is 8.25% (55/667) in our study. Most sandwich vertebrae (69.01%, 49/71) are distributed in the thoracic–lumbar junction. There are 24 sandwich vertebrae (18 patients) and 47 sandwich vertebrae (37 patients) in either prevention group or non-prevention group, respectively. No significant difference is found between age, sex, body mass index, bone mineral density, cement disk leakage, sandwich vertebrae distribution or Cobb angle in the two groups. In the follow-up, 8 out of 37 (21.6%) patients (with eight sandwich vertebrae) developed new fractures in non-prevention’ group, whereas no new fractures were detected in the prevention group. Neither Cobb angle nor vertebral compression rate showed significant change in the prevention group during the follow-up. However, in the non-prevention group, we found that Cobb angle increased and vertebral height lost significantly (P < 0.05).Prophylactic vertebroplasty procedure applied with resorbable bone cement could decrease the rate of new fractures of sandwich vertebrae.

Analysis of vertebral augmentation practice patterns: a 2016 update

ObjectiveTo evaluate procedure utilization patterns for vertebroplasty and kyphoplasty in the US Medicare population from 2004 to 2014.MethodsThe analysis was performed using the Centers for Medicare and Medicaid Services database...

Bone cement flow analysis by stepwise injection through medical cannulas

Cement leakage is a serious adverse event potentially occurring during vertebroplasty. Pre-operative in-silico planning of the cement filling process can help reducing complication rates related to leakage. This requires a better understanding of the cement flow along the whole injection path. Therefore, the aim of the present study was to analyze bone cement flow behavior by stepwise injections through medical cannulas.Sixteen cannulas were assigned to four groups for stepwise injection of differently colored cement portions of 1ml volume. Each group differed in the amount of injected cement portions with a range of 1–4ml. After cement curing longitudinal cross-sections of the cannulas were performed and high-resolution pictures taken. Based on these pictures, quadratic polynomial interpolation was applied to the marked intersections between the last two injected cement portions to calculate the leading coefficients.Leading coefficients in the groups with three cement portions (0.287 ± 0.078), four portions (0.243 ± 0.041) and two portions (0.232 ± 0.050) were comparable and significantly higher than the group with one cement portion (0.0032 ± 0.0004), p ≤ 0.016. Based on these findings, cement flow through medical cannulas can be considered as predictable and can therefore be excluded as a source of risk for possible cement leakage complications during vertebroplasty procedures.

A Review of PMMA Bone Cement and Intra-Cardiac Embolism.

Percutaneous vertebroplasty procedure is of major importance, given the significantly increasing aging population and the higher number of orthopedic procedures related to vertebral compression fractures. Vertebroplasty is a complex technique involving the injection of polymethylmethacrylate (PMMA) into the compressed vertebral body for mechanical stabilization of the fracture. Our understanding and ability to modify these mechanisms through alterations in cement material is rapidly evolving. However, the rate of cardiac complications secondary to PMMA injection and subsequent cement leakage has increased with time. The following review considers the main effects of PMMA bone cement on the heart, and the extent of influence of the materials on cardiac embolism. Clinically, cement leakage results in life-threatening cardiac injury. The convolution of this outcome through an appropriate balance of complex material properties is highlighted via clinical case reports.

Life-threatening paraspinal muscle hematoma after percutaneous vertebroplasty.

Bleeding and hematoma formation is rarely reported in percutaneous vertebroplasty procedure. An 84 year old male presented with a large paraspinal muscle hematoma after a percutaneous vertebroplasty. The patient had neither any prior bleeding disorder nor any anticoagulant treatment. Vital signs of the patient were unstable, and his hemoglobin level decreased daily. After a month of conservative treatment, including transfusion, cryotherapy, pain control and bed rest, his hemoglobin level remained stable and he showed relief from pain. Four months later, hematoma resolved spontaneously and he could walk without back pain.

Treatment for thoracolumbar spinal burst fracture in youth and middle-aged adults by bone cement filling

To verify whether the procedure of posterior instrumentation and vertebroplasty for treatment of thoracolumbar burst fracture in youth and middle-aged patients is safe, practical and effective in short- and long-term. A total of 50 patients aged 30-55 years old who suffered from thoracolumbar burst fracture complicated with incomplete paralysis or without neurologic symptom received surgery by using pedicle-screw implantation, reduction and bone cement filling through the unilateral or bilateral pedicles. The bone cement injection was conducted slowly and cautiously under monitor of fluoroscopy. Spinal canal exploration or decompression was performed regularly in follow-ups by X-ray films and CT scans. Cement leakage occurred in 5 cases without relevant symptom, including 1 case with leak from anterior aspect, 2 cases from lateral aspect, and 2 cases through ruptured end-plate into disc space. No spinal canal leakage or introvascular leakage was detected. The following-up duration was 5 to 10 years. There was no vertebral body height loss and regional kyphosis. The gaps within fractured vertebral body prior to surgery were disappeared completely. There was also no cement-bone interface detected. In 15 out of 50 cases, there were newly-formed bone bridges between fractured vertebral body and upper or lower adjacent vertebral body. There was no hardware failure occurred up to final follow-up. Bone cement filling combined with posterior instrumentation through pedicle-screw technique is a safe, practical and effective method for treatment of non-osteoporotic thoracolumbar spinal burst fractures without severe neurologic injury. The gaps among fracture fragments can be filled evenly and completely. Therefore, instant and permanent spinal stability can be achieved with excellent long-term result.

Armband activity monitor data do not correlate with reported pain scores in patients receiving vertebroplasty

BackgroundPrior research on the efficacy of vertebroplasty has focused primarily on subjective, patient-reported outcomes.ObjectiveTo apply an armband activity monitor (SenseWear by BodyMedia Inc, USA) to patients presenting for consideration for...

Noninvasive Failure Load Prediction of Vertebrae with Simulated Lytic Defects and Biomaterial Augmentation.

The spine is the most common site for secondary bone metastases, and clinical management for fractures is based on size and geometry of the defect. About 75% of the bone needs to be damaged before lesions are detectable, so clinical tools should measure changes in both geometry and material properties. We have developed an automated, user-friendly, Spine Cancer Assessment (SCA) image-based analysis method that builds on a platform designed for clinical practice providing failure characteristics of vertebrae. The objectives of this study were to (1) validate SCA predictions with experimental failure load outcomes; (2) evaluate the planning capabilities for prophylactic vertebroplasty procedures; and (3) investigate the effect of computed tomography (CT) protocols on predicted failure loads. Twenty-one vertebrae were randomly divided into two groups: (1) simulated defect without treatment (negative control) [n = 9] and (2) with treatment [n = 12]. Defects were created and a polymeric biomaterial was injected into the vertebrae in the treated-defect group. Spines were scanned, reconstructed with two algorithms, and analyzed for fracture loads. To virtually plan for prophylactic intervention, vertebrae with empty lesions were simulated to be augmented with either poly(methyl methacrylate) (PMMA) or a novel bone replacement copolymer, poly(propylene fumarate-co-caprolactone) [P(PF-co-CL)]. Axial rigidities were calculated from the CT images. Failure loads, determined from the cross section with the lowest axial rigidity, were compared with experimental values. Predicted loads correlated well with experimental outcomes (R(2) = 0.73, p < 0.0001). Predictions from negative control specimens highly correlated with measured values (R(2) = 0.90, p < 0.0001). Although a similar correlation was obtained using both algorithms, the smooth reconstruction (B30) tended to underestimate predicted failure loads by ∼50% compared with the ∼10% underestimate of the sharp reconstruction (B70). Percent increase in failure loads after virtual vertebroplasty showed a higher increase in samples with PMMA compared with those with copolymer. The SCA method developed in this study calculated failure loads from quantitative computed tomography scans in vertebrae with simulated metastatic lytic defects, with or without treatment, facilitating clinical applicability and providing more reliable guidelines for physicians to select appropriate treatment options. Furthermore, the analysis could accommodate augmentation planning procedures that aimed to determine the optimum material that would increase vertebral body failure load.

Transforaminal Endoscopic Solution to a Kyphoplasty Complication: Technical Note

Kyphoplasty is a minimally invasive spine surgical procedure performed to stabilize and treat the pain caused by a spine compression fracture. Complications are rare with kyphoplasty and include cement extrusion into the vertebral canal leading to spinal cord or nerve root compression. Herein, the authors present a case of a 72-year-old woman who presented with symptoms of a right L2 radiculopathy after a kyphoplasty procedure. Computed tomography imaging showed leakage of the kyphoplasty cement into the neural foramen above and medial to the right L2 pedicle. A transforaminal endoscopic surgical approach was used to remove the cement and decompress the L2 nerve. The patient's postoperative clinical course was uneventful. Clinicians should be aware that for the treatment of complications to vertebroplasty and kyphoplasty procedures, minimally invasive transforaminal endoscopic surgery is one option to avoid the destabilizing effects of laminectomy and facetectomy.