Use Of Percutaneous Vertebroplasty Research Articles

Vertebroplasty Versus Sham Intervention for Painful Chronic Osteoporotic Vertebral Compression Fractures (VERTOS 5): Randomised Sham Controlled Clinical Trial

Background: There is limited evidence to support the use of percutaneous vertebroplasty (PV) in chronic painful osteoporotic vertebral compression fractures (oVCFs). Methods: We performed a randomised sham-controlled clinical trial in patients with painful oVCFs older than three months with bone edema on magnetic resonance imaging (MRI). Patients were randomly assigned to undergo PV (cementation) or sham intervention (subcutaneous infiltration with 1% lidocaine followed by 0·25% bupivacaine into each pedicle and simulated cement injection). Outcomes were assessed at 1 day, 1 week and at 1, 3, 6 and 12 months. Primary outcome was change of pain on a scale of 0 to 10, with 10 being the maximum imaginable pain. Secondary outcomes were health-related quality of life (QUALEFFO) and physical functioning (RMD). Results: 80 patients were enrolled and randomised: PV (n=40) and sham intervention (n=40). Compared with baseline, the reduction in VAS score during 12 months in both groups was clinically and statistically significant at all measurement points. The mean VAS score at 12 months declined: 3·62 in the PV group (95% confidence interval 2·66 to 4·59) and 2.36 in the sham intervention group (1·42 to 3·31) with a significantly lower VAS score after PV at 12 months than sham intervention (p = 0·022). There was significant more improvement of quality of life (QUALEFFO) after PV compared to sham intervention, with a positive correlation for physical functioning (RMD). Conclusion: PV is superior to sham intervention for pain reduction in patients with chronic oVCFs of more than 3 months’ in duration with better quality of life results. Trial Registration: ClinicalTrials.gov NCT01963039; officially completed September 3, 2020. Funding Statement: Funding provided by Stryker Medical l and Medtronic. Declaration of Interests: None to declare Ethics Approval Statement: The protocol was approved by the institutional review board METC Brabant at the ETZ in the Netherlands and European Union Privacy Rules were followed. The protocol has been published in ClinicalTrials.gov (identifier: NCT01963039) and can be accessed online. All participants gave written informed consent to take part in the trial.

A review and update of vertebral fractures due to metastatic tumors of various sites to the spine: Percutaneous vertebroplasty.

BackgroundVertebral fractures (VFs) are the most usual convolution of metastatic tumors and the vertebral column is the third most ordinary site for painful bone metastases and remains a chief factor of morbidity in cancer patients.MethodsIn this paper, we investigated the previous literature on the status of clinical and prospects for the use of percutaneous vertebroplasty (PVP) with polymethylmethacrylate as a remedial alternative for the therapy of refractory pain resulting from malignant vertebral compression and pathologic fractures associated with metastatic tumors of various sites in numerous studies. The scientific document for this remedy, containing safety, immediate and long-term efficacy, and outcome measures, and also the risks of complications, was analyzed in detail.ResultsPVP is a safe, feasible, reliable, effective, and useful procedure, a minimally invasive treatment, and a significant tool for reduction of pain and the relief of pain symptoms.ConclusionsThis method can be employed as a further or narcotic remedy in elected patients. The techniques of PVP present a novel alternative therapy for diverse metastases with potentially large application.

In silico investigation of vertebroplasty as a stand-alone treatment for vertebral burst fractures

BackgroundThe use of percutaneous vertebroplasty as a stand-alone treatment for stable vertebral burst fractures has been investigated in vitro and in clinical studies. These studies present inconsistent results on the mechanical response of vertebroplasty-treated burst fractures. In addition, observations of the loss of sagittal alignment after vertebroplasty raise questions on the applicability of vertebroplasty for burst fractures. Therefore, the aim of this study was to investigate the mechanical stability of burst fractures after stand-alone treatment by vertebroplasty. MethodsFinite element simulations were performed with models generated from two laboratory-induced burst fractures in human thoracolumbar specimens. The burst fracture models were virtually injected with various cement volumes using a unipedicular or bipedicular approach. The models were subjected to four individual loads (compression, lateral bending, extension and torsion) and a multi-axial load case in the physiological range. FindingsAll treated burst fractures showed improvements in stiffness and a reduction in inter-fragmentary displacements, thus potentially providing a suitable mechanical environment for fracture healing. However, large volumes of the trabecular bone (<43%), cement (<53%) and bone–cement composite (<58%) were predicted to experience strain levels exceeding the yield point. While damage was not specifically modeled, this implies a potential collapse of the treated vertebra due to local failure. InterpretationTo improve the primary stability and to prevent the collapse of treated burst fractures, the use of posterior instrumentation is suggested as an adjunct to vertebroplasty.

SP0092 Osteoporosis. Whom, When and How to Treat

The evaluation and treatment of osteoporosis differ depending on several conditions such as the associated risk factors for the development of osteoporosis and fragility fractures, gender, age and menopausal status...

Cluster Phenomenon of Vertebral Refractures After Percutaneous Vertebroplasty in a Patient With Glucocorticosteroid-Induced Osteoporosis

A case report and literature review. To describe a rare cluster phenomenon of spontaneous vertebral refractures in a patient with glucocorticosteroid-induced osteoporosis (GIOP) subsequent to percutaneous vertebroplasty (PVP) for the management of initial vertebral compression fractures (VCFs). PVP has become the popular strategy for stabilizing osteoporotic VCFs and obtaining rapid pain alleviation and earlier restoration of mobility in both patients with primary osteoporosis and patients with glucocorticosteroid-induced osteoporosis. However, current data are insufficient to recommend routine use of PVP for VCFs caused by GIOP as recent retrospective studies indicate that the risk of vertebral refractures is much higher in patients with GIOP than those with primary osteoporosis. We reported a 63-year-old Chinese female with GIOP as well as pulmonary infection who underwent PVP for the management of initial VCFs, experienced the cluster phenomenon of spontaneous vertebral refractures. Within a 4-month period, she underwent a total of 6 PVP operations with 13 cement-augmented vertebral bodies from T5-L5. Eleven refractures after the initial PVP procedures included 3 remote-level fractures, 4 adjacent-level fractures, 1 pincher body fracture, and 3 fractures in previously augmented bodies. The average interval between each PVP operation was 23.6 days. The use of PVP as a therapeutic alternative for the treatment of VCFs in patients with GIOP is still controversial. As seen in our case, even when the management decisions were made in consideration of the patient's pulmonary infection, the outcome was disastrous with the cluster phenomenon of vertebral refractures. Current findings suggest a compelling need for high-quality studies investigating cement augmentation procedures in patients with VCF with GIOP.

Percutaneous Vertebroplasty for Pain Management in Patients with Multiple Myeloma: Is Radiofrequency Ablation Necessary?

This study was designed to investigate the added role of radiofrequency ablation (RFA) to vertebroplasty on the pain management of patients with multiple myeloma (MM). Thirty-six patients (51-82 years) with vertebral localization of MM were randomly divided into two groups: 18 patients (group A) who underwent RFA and then vertebroplasty, and 18 patients (group B) who underwent only vertebroplasty. Primary endpoints were technical success and pain relief score rate measured by the visual analogue pain scores (VAS) and Roland-Morris Questionnaire (RMQ); secondary endpoint was the amount of administered analgesia. Survival and complications were compared. Technical success was 100 % in both groups. The VAS score (at 24 h and 6 weeks postprocedure) decreased in equal manner for both groups from a mean of 9.1-3.4 and 2.0 for group A and from a mean of 9.3-3.0 and 2.3 for group B; RMQ mean score was 19.8 for group A and 19.9 for group B and decreased to a mean of 9.6 and 8.2 for group A and 9.5 and 8.7 for group B. The amount of medication was equally decreased in the two groups. No statistically significant difference was noted. No major complication occurred and two patients died from other causes. The use of percutaneous vertebroplasty alone appears to be effective for the pain management of the patients with vertebral involvement of multiple myeloma. The use of RFA that includes cost and time does not offer any clear added benefit on the midterm pain management of such patients.

Percutaneous vertebroplasty for Langerhans cell histiocytosis of the lumbar spine in an adult: Case report and review of the literature

Langerhans cell histiocytosis (LCH) is extremely rare in the lumbar spine of adults. The radiological features typically manifest as vertebral tumors. The exact etiology of LCH remains unknown. Langerhans cells may cause local or systemic effects. The most frequent sites of these bony lesions are the skull, femur, mandible, pelvis and spine. To date, only 3 spinal LCH cases treated by percutaneous vertebroplasty (PVP) have been reported. The present study reports a case of LCH of the fourth lumbar vertebra (L4) in a 51-year-old male with a 10-day history of low back pain, limited waist motion and right lower limb numbness. The patient was treated using PVP. The use of PVP for treating LCH of the spine was successful. The present study provides an up-to-date literature overview of LCH.

CT-Guided Percutaneous Vertebroplasty in the Treatment of an Upper Thoracic Compression Fracture

Percutaneous vertebroplasty (PVP) has been used to relieve pain and to prevent further collapse of the vertebral body in patients with an osteoporotic compression fracture. The most commonly affected site for the use of PVP is the thoracolumbar junction. There are few reports that have described on the usefulness of PVP in the treatment of a high thoracic compression fracture. We report a case of an upper thoracic compression fracture that was treated with computed tomography (CT)-guided PVP. It was possible to obtain easy access to the narrow thoracic pedicle and it was also possible to monitor continuously the proper volume of polymethylmethacrylate employed, under CT guidance.

Costs and State-Specific Rates of Thoracic and Lumbar Vertebroplasty, 2001–2005

Sequential cross-sectional analysis. To document vertebroplasty rates and costs. Little is known about interstate variation in rates or about nation-wide costs associated with the growing use of percutaneous vertebroplasty. Using specific CPT-4 billing codes, we reviewed aggregate Medicare Part B fee-for-service claims data (cross-stratified by physician specialty and treatment setting) on thoracolumbar vertebroplasties performed from 2001-2005. Vertebroplasty rates for individual states were expressed per 100,000 Part B fee-for-service enrollees. Nation-wide facility and physician charges (combining expected contributions from all sources) allowed by Medicare for vertebroplasties and associated imaging guidance procedures were applied to observed vertebroplasty volumes. These charges (reflecting direct medical costs from an all-payer perspective) were expressed in 2005 dollars using the Producer Price Index. Vertebroplasty rates for individual states rose but varied considerably, ranging from 0.0 to 515.6/100,000 Medicare Part B fee-for-service enrollees in 2001 (median state rate = 35.4), and from 9.8 to 849.5 in 2005 (median state rate = 75.0). On average, 1.3 vertebral levels were treated per procedure, varying by treatment site and physician specialty. Fluoroscopic rather than computed tomography guidance was used in 98.7% of cases. Total nation-wide inflation-adjusted charges rose from $76.0 million for 14,142 cases performed in 2001 to $152.3 million for 29,090 cases in 2005. While vertebroplasty was predominantly an outpatient procedure, inpatient cases generated most of the charges. Increasing volumes and costs were associated with cases performed in ambulatory surgery centers and physicians' offices. Nation-wide vertebroplasty volumes and inflation-adjusted charges doubled from 2001 to 2005 in this Medicare population. Procedure rates varied considerablyby state. Almost all cases involved fluoroscopic guidance; procedures treating multiple vertebral levels were not uncommon. Procedures performed in free-standing facilities are of growing importance. Given the issues surrounding appropriate vertebroplasty use, future practice patterns and outcomes should be closely tracked.

Acute respiratory failure associated with polymethyl methacrylate pulmonary emboli after percutaneous vertebroplasty

We report a case of symptomatic polymethyl methacrylate pulmonary emboli after percutaneous vertebroplasty to alert clinicians to this potential cause of pulmonary emboli. A 77-year-old woman developed acute respiratory failure after multilevel percutaneous vertebroplasty. She received mechanical ventilatory support and anticoagulation with low-molecular-weight heparin and warfarin. Multiple pulmonary polymethyl methacrylate cement emboli were identified by computed tomography angiogram. Polymethyl methacrylate cement extravasation into the vertebral venous circulation is common during vertebroplasty. Pulmonary embolism caused by cement migration after this procedure is extremely rare, as reported in the literature to date. However, the frequency of this complication may increase secondary to the widespread use of percutaneous vertebroplasty and kyphoplasty for osteoporotic compression fractures.

Use of Percutaneous Vertebroplasty for Intractable Back Pain Associated With Compression Fracture in an 80-Year-Old Female

Objective The aim of this study is to describe a patient with painful osteoporotic compression fracture and subsequent relief from percutaneous vertebroplasty (PVP). A brief review of vertebroplasty including indications, contraindications, and potential complications is discussed. Clinical Features An 80-year-old woman presented with severe low back pain and no history of trauma. Initial radiographs showed a typical benign, osteoporotic compression fracture of L1. Intervention and Outcome Percutaneous vertebroplasty was performed because of severe intractable low back pain. The patient had an excellent response to PVP. Postoperative radiographs showed only slight central compression fracture of L1 with partial central filling of the vertebral body with cement, and generalized osteopenia. Conclusion This article provides a case study and an overview of PVP. Percutaneous vertebroplasty may be a viable option for treatment of painful vertebral compression fractures if more conservative measures are unsuccessful.

C2/C3 pathologic fractures from polyostotic fibrous dysplasia of the cervical spine treated with percutaneous vertebroplasty

We will discuss a potential role of percutaneous vertebroplasty (PVP) in the management of patients with severe fibrous dysplasia of the spine with multiple cervical lesions and C2-C3 pathologic fractures that may not be a good surgical candidate. Polyostotic fibrous dysplasia involvement of the cervical spine is rare. Review of literature indicates only few reported cases of surgical management with one case of mortality indicating increased risks associated with surgical intervention. While PVP is commonly used for the treatment of osteoporotic thoracolumbar vertebral compression fractures, its role in vertebral stabilization for fibrous dysplasia has not been reported. A 35-year-old man with McCune-Albright syndrome and severe polyostotic fibrous dysplasia of C2 and C3 vertebrae presented with severe neck pain, radiculopathy, quadriparesis and myelopathy. The lesion had pathologic fractures, and there was an os odontoideum with cervical cord atrophy at the C1 level. After discussing need for aggressive surgical management and potential complications, we offered PVP due to surgical risks involved. PVP was performed with a posterolateral transpedicular approach without complication. The patient had remarkable improvement in clinical relief of neck pain and improvement of myelopathic symptoms at 1-year follow-up. We present a case that illustrates a potential use of PVP in the management of a patient with symptomatic spinal fibrous dysplasia with associated pathologic fractures who was poor surgical candidate.

Pathological Fractures from Craniocervical Polyostotic Fibrous Dysplasia Treated with Percutaneous Vertebroplasty: Case Report

We will discuss a potential role of percutaneous vertebroplasty (PVP) in the management of patients with severe fibrous dysplasia of the spine with multiple cervical lesions and C2-C3 pathologic fractures who may not be good surgical candidates. Polyostotic fibrous dysplasia involvement of the cervical spine is rare. Review of the literature indicates only few reported cases of surgical management with one case of mortality indicating increased risks associated with surgical intervention. While PVP is commonly used for the treatment of osteoporotic thoracolumbar vertebral compression fractures, its role in vertebral stabilization for fibrous dysplasia has not been reported. A 35-year-old man with McCune-Albright syndrome and severe polyostotic fibrous dysplasia of C2 and C3 vertebrae presented with severe neck pain, radiculopathy, quadriparesis, and myelopathy. The lesion had pathologic fractures, and there was an osodontoideum with cervical cord atrophy at the C1 level. After discussing need for aggressive surgical management and potential complications, we offered PVP because of the surgical risks involved. PVP was performed with a posterolateral transpedicular approach without complication. The patient had remarkable improvement in clinical relief of neck pain and improvement of myelopathic symptoms at the 1-year follow-up. We present a case that illustrates a potential use of PVP in the management of a patient with symptomatic spinal fibrous dysplasia with associated pathologic fractures who was a poor surgical candidate.

Evidence on the Effectiveness and Cost-effectiveness of Vertebroplasty: A review of Policy Makers’ Responses

This review paper tracks the growth in the evidence supporting the use of percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures. The rapidly increasing numbers of publications in the literature between 1994 and 2004 are documented. Despite the relatively large volume of research on this topic, several technology appraisals undertaken by international health policy makers reported inadequate high-quality evidence. Policy makers' reimbursement decisions for vertebroplasty and their options when faced with imperfect evidence are discussed.

Percutaneous vertebroplasty for treatment of thoracolumbar spine bursting fracture

Objective Percutaneous vertebroplasty can be very beneficial for patients with vertebral osteoporotic compression fractures. To the best of our knowledge, however, there has been no mention in any literature regarding the use of percutaneous vertebroplasty for the treatment of spinal burst fracture. Methods A preliminary study was conducted on 6 patients with traumatic burst fractures of vertebrae treated with percutaneous vertebroplasty starting in June 2000. Fractures involving the anterior and middle columns of the vertebrae and the canal were mildly compressed by the retropulsed bone fragment. However, there was no obvious neurologic deficit in these patients. They initially underwent conservative treatment and thoracolumbar spinal orthosis (TLSO) brace for at least 3 months, but the intractable pain caused patients to be bedridden for prolonged periods of time and limited daily activity. As a result, the patients underwent percutaneous vertebroplasty with polymethylmethacrylate (PMMA) for treatment of spinal burst fractures. Results Six male patients (mean age: 38.2) who suffered from burst fractures of vertebrae with disabling back pain refractory to analgesic therapy and TLSO brace were treated in this study. The duration of conservation treatment period was 3.5 months to 8 months (mean: 5.2 months). There was no motility. However, 4 vertebrae (66.7%), on radiographs revealed evidence of PMMA leakage through the endplate fracture site into either the disc space or the paravertebral space, without any evident clinical symptoms. No intracanal leakage was seen, and no patient needed a secondary surgical intervention. Pain decreased from 84.3 ± 5.4 mm at baseline to 34.7 ± 4.4 mm at the third postoperative day, 30.2 ± 5.8 at 3 months and 24 ± 3.5 mm at 12 months. The reduction in pain from baseline to the 3-day and 3 month mark was statistically significant ( p < 0.05). The mobility was at least 2 levels of improvement (mean improvement 2.7 points) at 12-months postoperative. Conclusion In highly selective patients, percutaneous vertebroplasty can be an alternative method for the treatment of spinal burst fractures and the prevention of complications from major surgical procedures. However, this procedure still has potential risks and should be employed with extreme caution to prevent extravasation of PMMA into the spinal canal.