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1.  Kummell’s disease: delayed post-traumatic osteonecrosis of the vertebral body 
European Spine Journal  2009;19(7):1065-1070.
Delayed post-traumatic osteonecrosis, also known by its eponym Kummell’s disease, is a rarely reported clinical entity that likely occurs with higher frequency than recognized. We highlight a case of a 75-year-old female household ambulator who presented with significant thoracolumbar pain and delayed T12 collapse after a ground-level fall. The patient had sustained a trivial fall at home 4 months prior to this presentation and had been hospitalized in our institution at that time for a general medical workup. Dedicated spine radiographs were not obtained during this visit. However, lateral chest radiograph demonstrated an intact T12 vertebral body. The patient was able to mobilize successfully with therapy and was discharged home. During the interim between the initial fall and subsequent presentation, she resumed physical activity including ambulating independently and performing various housework. Approximately 4 months following her initial injury, the patient returned to a local emergency department with vague complaints of abdominal pain without any history of recent fall or injury. After an unremarkable workup, the patient was sent home. Ten days later, she represented to our institution’s emergency room with worsening pain. Radiographs and CT scan demonstrated interval collapse of the T12 vertebral body. A linear vacuum cleft was noted on X-rays and CT. An extensive workup to exclude other processes such as malignancy or infection, which was negative, ensued. Delayed post-traumatic vertebral collapse was diagnosed. A trial of medical management and therapy was attempted, but she continued to experience significant pain. A T12 vertebroplasty was therefore offered and performed to stabilize the injury and to relieve the pain. She was subsequently able to be discharged from the hospital and transitioned back to home life. At approximately 2 years following her injury, the patient was noted to be able to ambulate with a walking aid. Her final radiograph after her surgery demonstrated that the T12 vertebroplasty had maintained its height and sagittal alignment. This Grand Round case highlights the clinical presentation of Kummell’s disease. Aspects of the clinical entity that will be discussed include a historical review of the disease, hallmark radiographic findings and treatment options.
PMCID: PMC2900014  PMID: 19949820
Kummell’s disease; Delayed vertebral osteonecrosis; Vertebral collapse; Vertebral pseudoarthrosis
2.  Complete motor recovery after acute paraparesis caused by spontaneous spinal epidural hematoma: case report 
Spontaneous spinal epidural hematoma is a relatively rare but potentially disabling disease. Prompt timely surgical management may promote recovery even in severe cases.
Case presentation
We report a 34-year-old man with a 2-hour history of sudden severe back pain, followed by weakness and numbness over the bilateral lower limbs, progressing to intense paraparesis and anesthesia. A spinal magnetic resonance imaging scan was performed and revealed an anterior epidural hematoma of the thoracic spine. He underwent an emergency decompression laminectomy of the thoracic spine and hematoma evacuation. Just after surgery, his lower extremity movements improved. After 1 week, there was no residual weakness and ambulation without assistance was resumed, with residual paresthesia on the plantar face of both feet. After 5 months, no residual symptoms persisted.
The diagnosis of spontaneous spinal epidural hematoma must be kept in mind in cases of sudden back pain with symptoms of spinal cord compression. Early recognition, accurate diagnosis and prompt surgical treatment may result in significant improvement even in severe cases.
PMCID: PMC3160384  PMID: 21794133
3.  Spontaneous chronic epidural hematoma of the lumbar spine mimicking an extradural spine tumour 
European Spine Journal  2012;22(Suppl 3):337-340.
Spontaneous chronic epidural hematomas are extremely rare and can be extremely challenging to diagnose and differentiate. The clinical findings, computed tomographic scan and magnetic resonance imaging does not always enough to complete differentiate this condition. Our purpose is to report a case of a spontaneous chronic epidural hematoma presenting as an extradural mass leading to compressive radicular symptoms with images of bony scalloping which are sparsely reported in the literature.
We describe a 61-year-old woman who was evaluated after 18-month history of pain, disestesias and mild weakness in both lower extremities with significant radicular symptoms on the right side associated to neurogenic claudication.
CT scans revealed a nodular image of soft tissue density located in the right anterolateral epidural space at the L4–L5 level demonstrating resorption of the bony margins. MRI studies revealed a round mass in the vertebral canal displacing the dural sac and scalloping the posterior wall of the L4 vertebral body. Diagnosis was established between a degenerative cyst versus an atypical neurinoma. Surgical findings demonstrated an isolated well-formed chronic hematoma.
Spontaneous chronic epidural hematomas are rare, even more when they produce scalloping of bony structures becoming a diagnostic challenge. Therefore they should be always considered as a differential diagnosis in patients with extradural chronic compressions taking into account that also chronic epidural hematomas can cause bone involvement.
PMCID: PMC3641257  PMID: 22718047
Tumour; Spine, epidural; Hematoma
4.  Full-endoscopic interlaminar removal of chronic lumbar epidural hematoma after spinal manipulation 
Spinal manipulation is widely used for low back pain treatments. Complications associated with spinal manipulation are seen. Lumbar epidural hematoma (EDH) is one of the complications reported in the literature. If lumbar chronic EDH symptoms are present, which are similar to those of a herniated nucleus pulposus, surgery may be considered if medical treatment fails. Percutaneous endoscopic discectomy utilizing an interlaminar approach can be successfully applied to those with herniated nucleus pulposus. We use the same technique to remove the lumbar chronic EDH, which is the first documented report in the related literature.
We present a case with chronic lumbar EDH associated with spinal manipulation. Neurologic deficits were noted on physical examination. We arranged for a full-endoscopic interlaminar approach to remove the hematoma for the patient with the rigid endoscopy (Vertebris system; Richard Wolf, Knittlingen, Germany).
After surgery, the patient's radiculopathy immediately began to disappear. Magnetic resonance imaging (MRI) follow-up 10 days after the surgery revealed no residual hematoma. No complications were noted during the outpatient department follow up.
Lumbar EDH is a possible complication of spinal manipulation. Patient experiencing rapidly progressive neurologic deficit require early surgical evacuation, while conservative treatment may only be applied to those with mild symptoms. A percutaneous full-endoscopic interlaminar approach may be a viable alternative for the treatment of those with chronic EDH with progressive neurologic deficits.
PMCID: PMC4033759  PMID: 24872917
Chronic epidural hematoma; endoscopic; interlaminar; lumbar; spinal manipulation
5.  Spontaneous Vertebral Reduction during the Procedure of Kyphoplasty in a Patient with Kummell's Disease 
The Korean Journal of Pain  2011;24(4):231-234.
Kummell's disease is a spinal disorder characterized by delayed post-traumatic collapse of a vertebral body with avascular necrosis. Although definitive treatment for Kummell's disease has not been established, it has been reported that percutaneous vertebroplasty or kyphoplasty has shown good results. However, these procedures are not recommended for severely collapsed vertebral bodies because of the risk of cement leakage or technical difficulties. Authors report a rare case of spontaneous reduction in vertebral height by the insertion of a working cannula into the vertebral body in Kummell's disease.
PMCID: PMC3248588  PMID: 22220246
compression fracture; kyphoplasty; osteoporosis
6.  Thoracic disc herniation causing transient paraplegia coincident with epidural anesthesia: a case report 
Cases Journal  2009;2:6228.
Neurological deficits following epidural or spinal anesthesia are extremely rare. Transient paraplegia following epidural anesthesia in a patient with thoracic disc herniation has been presented. A 44-year-old woman developed paraplegia during the operation for vascular surgery of her legs under epidural anesthesia. Epidural hematoma or spinal cord ischemia was ruled out by magnetic resonance imaging of the thoracic and lumbar spine in which protruded disc at T11-12 level compressing the spinal cord has been verified. Patient responded well to steroid treatment and rehabilitation interventions. Physicians should be aware of preceding disc protrusions, which may have detrimental effects on spinal cord perfusion, as a cause of persistent or transient paraplegia before epidural anesthesia procedure. MRI is a valuable imaging option to rule out epidural anesthesia complications and coexisting pathologies like disc herniations.
PMCID: PMC2769273  PMID: 19918563
7.  Principles of management of osteometabolic disorders affecting the aging spine 
European Spine Journal  2003;12(Suppl 2):S113-S131.
Osteoporosis is the most common contributing factor of spinal fractures, which characteristically are not generally known to produce spinal cord compression symptoms. Recently, an increasing number of medical reports have implicated osteoporotic fractures as a cause of serious neurological deficit and painful disabling spinal deformities. This has been corroborated by the present authors as well. These complications are only amenable to surgical management, requiring instrumentation. Instrumenting an osteoporotic spine, although a challenging task, can be accomplished if certain guidelines for surgical techniques are respected. Neurological deficits respond equally well to an anterior or posterior decompression, provided this is coupled with multisegmental fixation of the construct. With the steady increase in the elderly population, it is anticipated that the spine surgeon will face serious complications of osteoporotic spines more frequently. With regard to surgery, however, excellent correction of deformities can be achieved, by combining anterior and posterior approaches. Paget's disease of bone (PD) is a non-hormonal osteometabolic disorder and the spine is the second most commonly affected site. About one-third of patients with spinal involvement exhibit symptoms of clinical stenosis. In only 12–24% of patients with PD of the spine is back pain attributed solely to PD, while in the majority of patients, back pain is either arthritic in nature or a combination of a pagetic process and coexisting arthritis. In this context, one must be certain before attributing low back pain to PD exclusively, and antipagetic medical treatment alone may be ineffective. Neural element dysfunction may be attributed to compressive myelopathy by pagetic bone overgrowth, pagetic intraspinal soft tissue overgrowth, ossification of epidural fat, platybasia, spontaneous bleeding, sarcomatous degeneration and vertebral fracture or subluxation. Neural dysfunction can also result from spinal ischemia when blood is diverted by the so-called "arterial steal syndrome". Because the effectiveness of pharmacologic treatment for pagetic spinal stenosis has been clearly demonstrated, surgical decompression should only be instituted after failure of antipagetic medical treatment. Surgery is indicated as a primary treatment when neural compression is secondary to pathologic fractures, dislocations, spontaneous epidural hematoma, syringomyelia, platybasia, or sarcomatous transformation. Five classes of drugs are available for the treatment of PD. Bisphosphonates are the most popular antipagetic drug and several forms have been investigated.
PMCID: PMC3591829  PMID: 14505119
Osteoporosis; Fractures; Neurological deficit; Deformity; Paget's disease; Back pain; Spinal stenosis; Myelopathy; Treatment
8.  Balloon Kyphoplasty 
Executive Summary
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
9.  Postoperative spinal epidural hematoma resulting in cauda equina syndrome: a case report and review of the literature 
Cases Journal  2009;2:8584.
Spinal epidural hematoma is a well known complication of spinal surgery. Clinically insignificant small epidural hematomas develop in most spinal surgeries following laminectomy. However, the incidence of clinically significant postoperative spinal epidural hematomas that result in neurological deficits is extremely rare. In this report, we present a 33-year-old female patient whose spinal surgery resulted in postoperative spinal epidural hematoma. She was diagnosed with lumbar disc disease and underwent hemipartial lumbar laminectomy and discectomy. After twelve hours postoperation, her neurologic status deteriorated and cauda equina syndrome with acute spinal epidural hematoma was identified. She was immediately treated with surgical decompression and evacuation of the hematoma. The incidence of epidural hematoma after spinal surgery is rare, but very serious complication. Spinal epidural hematomas can cause significant spinal cord and cauda equina compression, requiring surgical intervention. Once diagnosed, the patient should immediately undergo emergency surgical exploration and evacuation of the hematoma.
PMCID: PMC2740261  PMID: 19830087
10.  Estimating the Incidence of Suspected Epidural Hematoma and the Hidden Imaging Cost of Epidural Catheterization: A Retrospective Review of 43,200 Cases 
Hematoma associated with epidural catheterization is rare, but the diagnosis might be suspected relatively frequently. We sought to estimate the incidence of suspected epidural hematoma after epidural catheterization, and to determine the associated cost of excluding or diagnosing an epidural hematoma through radiologic imaging.
We conducted an electronic retrospective chart review of 43,200 patient charts using 4 distinct search strategies and cost analysis, all from a single academic institution from 2001 through 2009. Charts were reviewed for use of radiological imaging studies to identify patients with suspected and confirmed epidural hematomas. Costs for imaging to exclude or confirm the diagnosis were related to the entire cohort.
In our analysis, over a 9-year period that included 43,200 epidural catheterizations, 102 patients (1:430) underwent further imaging studies to exclude or confirm the presence of an epidural hematoma—revealing 6 confirmed cases and an overall incidence (per 10,000 epidural blocks) of epidural hematoma of 1.38 (95% CI 0, 0.002). Among our patients, 207 imaging studies, primarily lumbar spine MRI, were performed. Integrating Medicare cost expenditure data, the estimated additional cost over a 9-year period for imaging and hospital charges related to identifying epidural hematomas nets to approximately $232,000 or an additional $5.37 per epidural.
About 1 in 430 epidural catheterization patients will be suspected to have an epidural hematoma. The cost of excluding the diagnosis, when suspected, is relatively low when allocated across all epidural catheterization patients.
PMCID: PMC3799821  PMID: 23924685
11.  Kummell disease 
Kummell disease, or avascular necrosis of a vertebral body, presents as vertebral osteonecrosis typically affecting a thoracic vertebra with compression deformity, intravertebral vacuum cleft, and exaggerated kyphosis weeks to months after a minor traumatic injury. This rare disease is increasing in prevalence secondary to an aging population and the associated rise in osteoporosis. Treatment with vertebroplasty or surgical decompression and fusion is often required. We present a classic case of Kummell disease to illustrate the salient features of the condition, with associated imaging findings on computed tomography and magnetic resonance imaging.
PMCID: PMC3684306  PMID: 23814399
12.  Dorsal Epidural Intervertebral Disk Herniation With Atypical Radiographic Findings: Case Report and Literature Review 
Intervertebral disk herniation is relatively common. Migration usually occurs in the ventral epidural space; rarely, disks migrate to the dorsal epidural space due to the natural anatomical barriers of the thecal sac.
Case report.
A 49-year-old man presented with 1 week of severe back pain with bilateral radiculopathy to the lateral aspect of his lower extremities and weakness of the ankle dorsiflexors and toe extensors. Lumbar spine magnetic resonance imaging with gadolinium revealed a peripheral enhancing dorsal epidural lesion with severe compression of the thecal sac. Initial differential diagnosis included spontaneous hematoma, synovial cyst, and epidural abscess. Posterior lumbar decompression was performed; intraoperatively, the lesion was identified as a large herniated disk fragment.
Dorsal migration of a herniated intervertebral disk is rare and may be difficult to definitively diagnose preoperatively. Dorsal disk migration may present in a variety of clinical scenarios and, as in this case, may mimic other epidural lesions on magnetic resonance imaging.
PMCID: PMC2920122  PMID: 20737802
Vertebral disk, herniation; Back pain, radiculopathy; Abscess, epidural; Hematoma, epidural; Laminectomy; Decompression, lumbar
13.  Spontaneous and idiopathic chronic spinal epidural hematoma: two case reports and review of the literature 
European Spine Journal  2009;18(11):1555-1561.
Spinal epidural hematoma (SEH) represents the most frequent entity of acute or chronic spinal bleeding. Based upon pathogenesis, SEH can be classified as idiopathic, spontaneous, and secondary. The idiopathic forms are considered not to be attributed to any specific risk factors. Spontaneous SEH, accounting for 0.3–0.9% of all spinal epidural space occupying lesions, instead is associated with risk factors (such as substantial soft trauma or coagulation abnormalities). The chronic form, as our literature review revealed, is the rarest and its most frequent location is the lumbar spine. The pathophysiology of spontaneous and idiopathic SEH is still under debate: There are only a few reports in literature of chronically evolving SEH with progressively increasing pain and neurological impairment. Magnetic resonance imaging may be inconclusive for differential diagnosis. Here, we present two cases of lumbar chronic SEH with slow, progressive, and persistent lumbar radicular impairment. The first patient reported a minor trauma with slight back contusion and thus was classified as spontaneous SEH. In the second case not even a minor trauma was involved, so we considered it to be idiopathic SEH. In both cases preoperative blood and coagulation tests were normal and we did not find any other or co-factors in the patients’ clinical histories. MR imaging showed uncertain spinal canal obstructing lesions at L3 and L4 level in both cases. Surgical treatment allowed a correct diagnosis and resulted in full clinical and neuroradiological recovery after 1 year follow-up. Our aim is to discuss pathogenesis, clinical and radiological features, differential diagnosis and treatment options, on the background of relevant literature review.
PMCID: PMC2899401  PMID: 19859747
Spontaneous; Idiopathic; Chronic; Hematoma; Epidural; Spinal
14.  Idiopathic Hypertrophic Spinal Pachymeningitis : Report of Two Cases and Review of the Literature 
Idiopathic hypertrophic spinal pachymeningitis (IHSP) is a rare inflammatory disease characterized by hypertrophic inflammation of the dura mater and various clinical courses that are from myelopathy. Although many associated diseases have been suggested, the etiology of IHSP is not well understood. The ideal treatment is controversial. In the first case, a 55-year-old woman presented back pain, progressive paraparesis, both leg numbness, and voiding difficulty. Initial magnetic resonance imaging (MRI) demonstrated an anterior epidural mass lesion involving from C6 to mid-thoracic spine area with low signal intensity on T1 and T2 weighted images. We performed decompressive laminectomy and lesional biopsy. After operation, she was subsequently treated with steroid and could walk unaided. In the second case, a 45-year-old woman presented with fever and quadriplegia after a spine fusion operation due to lumbar spinal stenosis and degenerative herniated lumbar disc. Initial MRI showed anterior and posterior epidural mass lesion from foramen magnum to C4 level. She underwent decompressive laminectomy and durotomy followed by steroid therapy. However, her conditions deteriorated gradually and medical complications occurred. In our cases, etiology was not found despite through investigations. Initial MRI showed dural thickening with mixed signal intensity on T1- and T2-weighted images. Pathologic examination revealed chronic nonspecific inflammation in both patients. Although one patient developed several complications, the other showed slow improvement of neurological symptoms with decompressive surgery and steroid therapy. In case of chronic compressive myelopathy due to the dural hypertrophic change, decompressive surgery such as laminectomy or laminoplasty may be helpful as well as postoperative steroid therapy.
PMCID: PMC3243847  PMID: 22200026
Idiopathic hypertrophic spinal pachymeningitis; Spinal cord compression; Chronic nonspecific inflammation; Dural thickening
15.  Delayed Postoperative Epidural Hematoma Presenting Only with Vesicorectal Disturbance 
Case Reports in Orthopedics  2013;2013:861961.
We present a rare case of delayed onset of epidural hematoma after lumbar surgery whose only presenting symptom was vesicorectal disturbance. A 68-year-old man with degenerative spinal stenosis underwent lumbar decompression and instrumented posterolateral spine fusion. The day after his discharge following an unremarkable postoperative course, he presented to the emergency room complaining of difficulty in urination. An MRI revealed an epidural fluid collection causing compression of the thecal sac. The fluid was evacuated, revealing a postoperative hematoma. After removal of the hematoma, his symptoms disappeared immediately, and his urinary function completely recovered. Most reports have characterized postoperative epidural hematoma as occurring early after operation and accompanied with neurological deficits. But it can happen even two weeks after spinal surgery with no pain. Surgeons thus may need to follow up patients for at least a few weeks because some complications, such as epidural hematomas, could take that long to manifest themselves.
PMCID: PMC3773434  PMID: 24073350
16.  Paget's Disease of the spine and its management 
European Spine Journal  2001;10(5):370-384.
A review of the literature was conducted to study the pathomechanics by which Paget's Disease of bone (PD) alters the spinal structures that result in distinct spinal pathologic entities such as pagetic spinal arthritis, spinal stenosis, and other pathologies, and to assess the best treatment options and available drugs. The spine is the second most commonly affected site with PD. About one-third of patients with spinal involvement exhibit symptoms of clinical stenosis. In only 12–24% of patients with PD of the spine is back pain attributed solely to PD, while in the majority of patients back pain is either arthritic in nature or a combination of a pagetic process and coexisting arthritis. Neural element dysfunction may be attributed to compressive myelopathy by pagetic bone overgrowth, pagetic intraspinal soft tissue overgrowth, ossification of epidural fat, platybasia, spontaneous bleeding, sarcomatous degeneration and vertebral fracture or subluxation. Neural dysfunction can also result from spinal ischemia, when blood is diverted by the so-called ''arterial steal syndrome''. Because the effectiveness of pharmacologic treatment for pagetic spinal stenosis has been clearly demonstrated, surgical decompression should only be instituted after failure of antipagetic medical treatment. Surgery is indicated as a primary treatment when neural compression is secondary to pathologic fractures, dislocations, spontaneous epidural hematoma, syringomyelia, platybasia, or sarcomatous transformation. Since, in the majority of cases with pagetic spinal involvement, there are also coexisting osteoarthritic changes, antipagetic medical treatment alone may be disappointing. Therefore, one must be careful before attributing low back pain to PD alone. Five classes of drugs are available for the treatment of PD: bisphosphonates, calcitonins, mithramycin (plicamycin), gallium nitrate, and ipriflavone. Bisphosphonates are the most popular, and several forms have been investigated, but only the following forms have been approved for clinical use: disodium etidronate, clodronate, aledronate, risedronate, neridronate, pamidronate, tiludronate, ibadronate, aminohydroxylbutylidene bisphosphonate, olpadronate, and zoledronate. Several of these forms are still under investigation.
PMCID: PMC3611523  PMID: 11718191
Paget's Disease Back pain Spinal stenosis Myelopathy Complications Medical treatment Surgery Review
17.  The Fracture Unit Model. A Model for Implementation in Italy: “Multidisciplinary Approach for the Prevention and Treatment of Osteoporotic Vertebral Compression Fractures: VCF Unit” 
Reduced BMD is a risk factor for vertebral fractures (VFs). Every one SD increase in BMD is associated with a 2- to 2.5-fold increase in the risk of VFs. The presence of a previous fracture, vertebral or of other districts, is another important predictor of an increased risk of future fractures, independently of the association between BMD and fracture risk. Thus, the presence of both a low BMD and a previous fracture dramatically increases fracture risk. The definition of osteopo-rotic VFs has undergone considerable variations over the years, going from initial clinical sign of OP, through the now superseded definition of VFs as a disease, to a complication of OP resulting from bone fragility. The prevalence of VFs increases with age in both sexes, and it is calculated that at the age of 80 years, 37% of Caucasian women will have at least one radiographically evident VF. It has been estimated, again in Caucasian women, that the percentage incidence of fractures is 0.5% in those aged 50-55 years, 1.4% in those aged 65-69 years, and over 2% in women older than 75. However, two factors prevent an accurate assessment of the epidemiology of VFs. First, most VFs escape clinical diagnosis. Second, the absence of a “gold standard” radiographic definition of VFs has given rise to different ways of defining these lesions. VFs are rarely a cause of mortality, but they are associated with increased impairment of general conditions. Recurrent VFs have irreversible clinical consequences, such as reduction of height and chronic vertebral pain, which provoke an intensification of the pain and a greater degree of disability due to accentuation of kyphosis. The presence of VFs and kyphosis leads to a reduced thoracic volume and, consequently, to a loss of lung volume, in some cases severe enough to result in respiratory insufficiency. The consequences of the intense pain are: reduced range of motion, loss of balance, slowed gait and greater difficulty carrying out normal daily activities. In rare cases, lower limb pain and weakness may appear, caused by compression of the spinal medulla by the deformed vertebral body. The main aim of treatment is to restore the patient to his/her pre-trauma levels of functioning. This can be achieved through recourse to mini-invasive percutaneous techniques, vertebroplasty and kyphoplasty, with the aim of reducing the pain caused by osteo-porotic vertebral compression fractures, of preventing progression of the vertebral collapse and of rapidly re-establishing functional activity. Most fracture patients are discharged without undergoing a thorough bone metabolism assessment that could identify the causal factor of the fracture. In a high percentage (up to 95%) of patients with recent fractures, BMD is not measured and, therefore, a diagnosis of OP is not made. Consequently, these patients are not prescribed drugs capable of effectively reducing the risk of further fractures. Specialist orthopaedic centres need to introduce protocols designed to ensure application of the current procedures for diagnosing and treating OP.
On the basis of these considerations, we undertook to develop, in collaboration with the Department of Specialist Surgical Sciences of the University of Florence, the Orthopaedics and Traumatology Units 1, 2 and 3, the Recovery and Functional Re-education Unit, the Neurosurgery Unit, and the third Radiodiagnostics Unit of the Careggi Hospital in Floren-ce, a protocol that involves a range of specialists in assessing the introduction of variable, outcome-targeted medical therapies for osteoporotic patients submitted to kyphoplasty following fragility fractures of the vertebra. To choose the appropriate medical therapy, and to monitor its effects, the patients will be submitted to a series of clinical investigations. The “appropriate” therapy could include calcium and vitamin D supplementation, biphosphonates, SERMs, bone anabolic agents and combinations of drugs. The safety of the medical therapy and any adverse effects will be monitored at each follow-up visit through an appropriate questionnaire. This study aims to compare the outcomes of the group following a traditional pathway with those following a modified pathway (prescription of a targeted medical therapy), by means of metabolic, instrumental and functional tests performed at 2 months, 6 months, 1 year and 2 years. The general aim of the study will be to evaluate the efficacy and safety of a modified versus a traditional pathway in the care of osteoporotic patients undergoing kyphoplasty for VFs. The primary endpoint of the study will be the percentage of successes in the modified compared with the traditional pathway group. Secondary endpoints will be: change in femoral and lumbar BMD, changes in biochemical markers of bone remodelling and quality of life, assessment of safety parameters: overall and symptomatic cement leakage, pulmonary embolism, spinal medulla compression, radicular pain, radiculopathies and assessment of total procedure-related, cement-related and access-related adverse events. The ultimate aim of the study will be to prepare guidelines for the management, in terms of metabolic diagnosis and relative medical therapy, of patients with OP complicated by VFs.
PMCID: PMC3213825
18.  Spontaneous Bilateral Supratentorial Subdural and Retroclival Extradural Hematomas in Association with Cervical Epidural Venous Engorgement 
We describe a case of 36-year-old man who presented with a subacute headache preceded by a 1-month history of posterior neck pain without trauma history. Head and neck magnetic resonance imaging (MRI) studies disclosed bilateral supratentorial subdural and retroclival extradural hematomas associated with marked cervical epidural venous engorgement. Cerebral and spinal angiography disclosed no abnormalities except dilated cervical epidural veins. We performed serial follow-up MRI studied to monitor his condition. Patient's symptoms improved gradually. Serial radiologic studies revealed gradual resolution of pathologic findings. A 3-month follow-up MRI study of the brain and cervical spine revealed complete resolution of the retroclival extradural hematoma, disappearance of the cervical epidural venous engorgement, and partial resolution of the bilateral supratentorial subdural hematoma. Complete resolution of the bilateral supratentorial subdural hematoma was confirmed on a 5-month follow-up brain MRI. The diagnosis and possible mechanisms of this rare association are discussed.
PMCID: PMC2744030  PMID: 19763223
Supratentorial subdural hematoma; Retroclival extradural hematoma; Cervical epidural venous engorgement
19.  Histopathological Findings of Hemorrhagic Ganglion Cyst Causing Acute Radicular Pain: A Case Report 
Korean Journal of Spine  2013;10(4):242-245.
Although juxtafacet cysts of the lumbar spine are being reported with increasing frequency, hemorrhage from a ganglion cyst is rare, and the pathophysiologic mechanism of the hemorrhage from the cyst is still unclear. A 75-year-old male presented with sudden radicular leg pain caused by hemorrhage from the ganglion cyst. Computed tomography revealed bony erosion of vertebral body and multiple punched-out lesions on facets. Magnetic resonance imaging showed the neural structure was compressed by a sharply delineating mass. Capsule and old hematoma with elastic consistency that extended to the epidural space were removed through a paramedian transforaminal approach, which led to the resolution of the patient's symptoms. Histopathologically, chronic inflammation with neovascularization and myxoid degeneration were present in the capsule. Alcian blue staining demonstrated the mixture of mucin and hematoma. The probable pathogenesis of hemorrhage from the cyst was discussed from the unique histopathological findings of surgical specimen.
PMCID: PMC4040643  PMID: 24891856
Ganglion cyst; Hemorrhage; Lumbar vertebrae; Mucins; Radiculopathy; Zygapophyseal joint
20.  An Unusual Case of Post-Operative Spondylitis Caused by Mycobacterium Intracellulare in an Immunosuppressed Patient 
There are few reported cases of post-operative spondylitis caused by Mycobacterium intracellulare. A 75-year-old female presented to our hospital with low back pain and paraparesis after a fall. The radiologic examination revealed compression fractures of L1, L3 and L4 and an epidural hematoma compressing the spinal cord. The dark-red epidural hematoma was urgently evacuated. Four weeks post-operatively, neurologic deficits recurred with fever. On magnetic resonance image, an epidural abscess and osteomyelitis were detected in the previous operative site. Five weeks post-operatively, revision was performed with multiple biopsies. The specimen were positive for acid-fast bacilli and traditional anti-tuberculous medications were started. Because the Polymerase Chain Reaction for non-tuberculous mycobacterium (NTM) was positive, the anti-tuberculous medications were changed to anti-NTM drugs. However, the neurologic deficits did not improve and persistent elevation of erythrocyte sedimentation rate and C-reactive protein were noted. Eight weeks after the revision, Mycobacterium intracellulare was detected in the specimen cultures. Despite supportive care with medication, the patient died due to multiple organ failure.
PMCID: PMC3259468  PMID: 22259695
Post-operative spondylitis; Mycobacterium intracellulare
21.  Extensive Postoperative Epidural Hematoma After Full Anticoagulation: Case Report and Review of the Literature 
A 67-year-old man with degenerative lumbar spinal stenosis and a medical history significant for coronary artery disease underwent routine lumbar surgical decompression. The objective of this study was to report a case of postoperative epidural hematoma associated with the use of emergent anticoagulation, including the dangers associated with spinal decompression and early postoperative anticoagulation.
Case report.
After anticoagulation therapy for postoperative myocardial ischemia, the patient developed paresis with ascending abdominal paraesthesias. Immediate decompression of the surgical wound was carried out at the bedside. Magnetic resonance imaging revealed a massive spinal epidural hematoma extending from the middle of the cervical spine to the sacrum. Emergent cervical, thoracic, and revision lumbar laminectomy without fusion was performed to decompress the spinal canal and evacuate the hematoma.
Motor and sensory function returned to normal by 14 days postoperatively, but bowel and bladder function continued to be impaired. Postoperative radiographs showed that coronal and sagittal spinal alignment did not change significantly after extensive laminectomy.
Full anticoagulation should be avoided in the early postoperative period. In cases requiring early vigorous anticoagulation, patients should be closely monitored for changes in neurologic status. Combined cervical, thoracic, and lumbar laminectomy, without instrumentation or fusion, is an acceptable treatment option.
PMCID: PMC2031966  PMID: 17684896
Spinal stenosis, lumbar; Spinal decompression; Anticoagulation; Epidural hematoma; Laminectomy
22.  Drug interaction as cause of spontaneously resolving epidural spinal hematoma on warfarin therapy 
We present a case of a 42-year-old male, an old case of deep vein thrombosis on warfarin and other drugs like quetiapine, aspirin, diclofenac sodium, fenofibrate, atorvastatin, propanolol and citalopram for concurrent illnesses, who presented with widespread mucocutaneous bleeding and epidural spinal hematoma. The epidural bleed presented clinically as a nontraumatic, rapidly improving myeloradiculopathy. Magnetic resonance imaging (MRI) of the spine revealed an epidural hematoma at D12-L1 level. The case was managed conservatively due lack of neurosurgical facilities. The patient gained full neurological recovery on conservative management alone. This case highlights the problem of drug interaction on warfarin therapy and also an unusual spontaneous recovery of spinal hematoma. Our case was anticoagulated in the recommended therapeutic INR range of 2.2 to 2.4. Most of the similar cases reported in literature were also anticoagulated in the therapeutic range. Thus intraspinal hemorrhage is a rare but dangerous complication of anticoagulant therapy. It must be suspected in any patient on anticoagulant agents who complains of local or referred spinal pain associated with neurological deficits. Drug interactions with warfarin are common. High suspicion and immediate intervention are essential to prevent complications from intraspinal hemorrhage.
PMCID: PMC3137834  PMID: 21799620
Anticoagulant; spinal epidural hematoma; warfarin
23.  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
24.  Surgical management of spontaneous spinal epidural hematoma 
European Spine Journal  2006;15(6):998-1004.
Spontaneous spinal epidural hematoma (SSEH) is a rare disease entity; its causative factors and the factors determining the outcome are still controversial. We reviewed our clinical experiences and analyzed the various factors related to the outcome for SSEH. We investigated 14 patients (11 men and 3 women) who underwent hematoma removal for SSEH from April 1998 to August 2004. We reviewed age, gender, hypertension, anticoagulant use and the preoperative neurological status using the Japanese Orthopaedics Association score by examining medical records, operative records, pathology reports, and radiographies, retrospectively. We were checking for factors such as the degree of cord compression owing to hematoma and the extent and location of the hematoma. Most patients included in the study were in their twenties or fifties. Four hematoma were located in the cervical region (29%), three were cervicothoracic (21%), four were thoracic (29%) and three were in the lumbar (21%) region and also 12 were located at the dorsal aspect of the spinal cord. In all cases, the neurological outcome improved after the surgical operation. There was a statistically significant difference between the incomplete and complete neurological injury for the preoperative status (P<0.05). The neurological outcome was good in those cases that had their hematoma removed within 24 h (P<0.05). The patients with incomplete neurological injury who had a surgical operation performed within 12 h had an excellent surgical outcome (P<0.01). Spontaneous spinal epidural hematoma was favorably treated by the means of a surgical operation. The favorable factors for SSEH operations were incomplete neurological injury at the time of the preoperative status and the short operative time interval.
PMCID: PMC3489451  PMID: 16758110
Epidural hematoma; Cord injury; Operative time interval; Spine surgery
25.  Postoperative Spinal Epidural Hematoma: Risk Factor and Clinical Outcome 
Yonsei Medical Journal  2006;47(3):326-332.
We report a series of epidural hematomas which cause neurologic deterioration after spinal surgery, and have taken risk factors and prognostic factors into consideration. We retrospectively reviewed the database of 3720 cases of spine operation in a single institute over 7 years (1998 April-2005 July). Nine patients who demonstrated neurologic deterioration after surgery and required surgical decompression were identified. Factors postulated to increase the postoperative epidural hematoma and to improve neurologic outcome were investigated. The incidence of postoperative epidural hematoma was 0.24%. Operation sites were cervical 3 cases, thoracic 2 cases, and lumbar 4 cases. Their original diagnoses were tumor 3 cases, cervical stenosis 2 cases, lumbar stenosis 3 cases and herniated lumbar disc 1case. The symptoms of epidural hematomas were neurologic deterioration and pain. After decompression, clinical outcome revealed complete recovery in 3 cases (33.3%), incomplete recovery in 5 cases (55.6%) and no change in 1 case (11.1%). Factors increasing the risk of postoperative epidural hematoma were coagulopathy from medical illness or anticoagulation therapy (4 cases, 44.4%) and highly vascularized tumor (3 cases, 33.3%). The time interval to evacuation of complete recovery group (29.3 hours) was shorter than incomplete recovery group (66.3 hours). Patients with coagulopathy and highly vascularized tumor were more vulnerable to spinal epidural hematoma. The postoperative outcome was related to the preoperative neurological deficit and the time interval to the decompression.
PMCID: PMC2688151  PMID: 16807981
Clinical outcome; risk factor; postoperative; spinal epidural hematoma; spine surgery

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