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1 Department of Diagnostic Radiology, Singapore General Hospital, Outram Rd.,
Singapore 169608.
2 Mallinckrodt Institute of Radiology, Washington University Medical Center, St.
Louis, MO 63110.
3 Present address: Gem State Radiology, 877 W. Main St., Ste. 603, Boise, ID
83702.
Received January 17, 2002;
accepted after revision October 22, 2002.
Address correspondence to L. A. Gilula.
Abstract
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MATERIALS AND METHODS. Nineteen cases of painful vertebral compression fractures with intraosseous phenomena occurring in 18 patients (six men, 12 women; age range, 59-88 years; mean age, 75.5 years) were identified from 393 percutaneous vertebroplasties performed in 199 patients during 32 and a half months. All patients had osteoporosis, with severe vertebral compression to less than one third of the vertebral body height in 13 of 19 cases. Affected levels were T6 (n = 1), T8 (n = 2), T9 (n = 1), T11 (n = 1), T12 (n = 4), L1 (n = 5), L2 (n = 2), L3 (n = 1), L4 (n = 1), and L5 (n = 1). All cases had the typical intravertebral body vacuum cleft appearance on radiographs. Imaging and clinical features were analyzed.
RESULTS. The mean volume of polymethyl methacrylate injected was 7.43 mL (range, 4.0-15.0 mL). Typically, the polymethyl methacrylate filled the intravertebral vacuum cleft. Complications during radiography consisted of minimal polymethyl methacrylate leakage into the adjacent disk (15/19 cases) and the paravertebral soft tissues (8/19 cases). No complications required surgical intervention. At clinical follow-up, pain relief was complete in eight patients (44.4%), partial in six patients (33.3%), and unchanged in four patients (22.2%).
CONCLUSION. Percutaneous vertebroplasty is effective in the treatment of patients with painful vertebral compression fractures with intraosseous vacuum phenomena.
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Percutaneous vertebroplasty was performed under stringent sterile conditions and with fluoroscopic guidance using a C-arm angiographic unit (Angioskop 33; Siemens, Erlangen, Germany). All patients were in a prone position during the procedure, and their vital signs were monitored continually. IV fentanyl citrate (Sublimaze; Abbott Laboratories, North Chicago, IL) and midazolam hydrochloride (Versed; Roche Pharmaceuticals, Manati, Puerto Rico) were administered for analgesia and sedation, respectively. After a small skin incision was made, an 11-or 13-gauge bone biopsy trochar needle was advanced through the pedicle into the vertebral body. Ideally, the needle tip was placed in the anterior one third to one fourth of the vertebral body close to the midline. In our study, the major exception to this needle-tip placement was the situation in which the center of the vertebral body was prominently more depressed than the sides of the vertebral body. In that situation, the needle was placed more laterally to decrease the incidence of polymethyl methacrylate leakage into the disk.
When the needle tip was optimally positioned, the stylet was removed from the trochar and intraosseous epidural venography using 0.5-2.0 mL of iohexol (Omnipaque 180; Nycomed, Princeton, NJ) was performed to determine whether the needle was positioned within a direct venous anastomosis. Intraosseous venography also enabled observation of the venous structures that filled first and indicated the most likely place to observe first for potential polymethyl methacrylate venous filling. Contrast material injection was stopped immediately after filling the fracture cleft so that the cleft would not be fully opacified. Methyl methacrylate powder (Osteobond copolymer bone cement; Zimmer, Warsaw, IN) was mixed with sterilized barium sulfate powder (E-Z-EM; Westbury, NY) and 1.2 g of tobramycin (Nebcin; Eli Lilly, Indianapolis, IN). Later in our experience, we discontinued the use of tobramycin because it was unavailable; we then began to use IV cefazolin (Ancef; Beecham, Philadelphia, PA) unless a patient was allergic to penicillin. Liquid methyl methacrylate monomer was then added to the powder mixture and mixed into a toothpastelike consistency. The polymethyl methacrylate mixture was placed in the back of a 20-mL syringe and then backfilled into a screw-type 10-mL syringe (LeVeen; Boston Scientific, Glen Falls, NY).
Under lateral fluoroscopic control, the polymethyl methacrylate mixture was injected until it reached the posterior quarter of the vertebral body, until the mixture started to pass into the disk space or paravertebral tissues, or until the fracture cleft was completely filled. If too much resistance for the 10-mL syringe was encountered, special strong-walled 1-mL syringes (Medallion [Merit Medical Systems, South Jordan, UT]) were backfilled quickly and used to fill the vertebral body more completely. If leakage occurred outside the vertebra, the injection was halted for 1-2 min to allow the polymethyl methacrylate to harden, in an attempt to plug the leak, or the needle was repositioned. If the polymethyl methacrylate mixture did not pass the midline to the opposite side of the vertebral body, the opposite pedicle was then punctured. In some cases, only the vacuum cleft was filled with polymethyl methacrylate and a large amount of bone without polymethyl methacrylate was present below the fracture cleft. When this occurred, a needle (typically directed through the opposite pedicle) was inserted in the vertebral body inferior to the vacuum cleft to try to get polymethyl methacrylate to fill the remaining part of the vertebral body.
Two musculoskeletal radiologists analyzed the imaging and clinical features in consensus. Particular attention was paid to the presence of vacuum phenomenon, the volume of polymethyl methacrylate injected, the location of involved vertebra, radiographic complications of polymethyl methacrylate leakage, and clinical outcome. The MR images of all patients were reviewed for the presence of a cleftlike lesion in the compressed vertebral body. Radiographs obtained before the vertebroplasty were also reviewed to determine whether vacuum phenomenon was present in the disks adjacent to the compressed vertebral body. Radiographs obtained after the procedure were reviewed to specifically check whether an increase occurred in the vertebral body height after the polymethyl methacrylate injection. Patients were evaluated for their pain score before vertebroplasty using a visual analog (0-10) scale. After vertebroplasty, assessment was performed at regular intervals: immediately after vertebroplasty and at 24 hr, 2 weeks, 1 month, 3 months, 1 year, and 2 years. Institutional review board approval was obtained to allow a person trained in patient research to perform telephone follow-up with each patient after vertebroplasty. During this interview, a questionnaire was completed to determine whether the patient's pain was completely relieved, partially relieved, unchanged, or worse.
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In this study, adequate MR images were available for evaluation of 14 of the 19 affected vertebrae. On review of MR images, a linear band that was hypointense on both T1- and T2-weighted images was detected in the collapsed vertebral body in all 14 cases. In three of the 14 cases with available MR images, a component of a linear band was present that was hypointense on T1- and hyperintense on T2-weighted images (Figs. 2A, 2B, 2C, 2D and 2E). This intravertebral-body linear band that was present on MR images, whether hypointense or hyperintense, corresponded to the intravertebral-body vacuum cleft seen on radiographs (Figs. 2A, 2B, 2C, 2D, 2E and 3A, 3B).
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In 18 of the 19 cases, the height of the vertebra after placement of polymethyl methacrylate was seen to be increased on radiographs obtained for verification after vertebroplasty (Figs. 1A, 1B, 1C, 1D, 2A, 2B, 2C, 2D, 2E, and 4A, 4B, 4C). We found that, occasionally, placing body supports of various heights under the chest and pelvis to hyperextend the spine at the level of the involved vertebral body while these patients were in a prone position helped restore the vertebral body height (Figs. 1A, 1B, 1C and 1D).
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The mean volume of polymethyl methacrylate injected was 7.43 mL (range, 4.0-15.0 mL). The polymethyl methacrylate typically filled the intravertebral vacuum cleft (Figs. 1A, 1B, 1C, 1D, 2A, 2B, 2C, 2D, 2E, and 4A, 4B, 4C). Bilateral pedicle injection was performed in two of 19 cases; 17 of 19 cases underwent unilateral pedicle injection. Preferential filling of the vacuum cleft occurred. Radiographic complications included polymethyl methacrylate leakage into the adjacent disk (15/19 cases) and the paravertebral soft tissues (8/19 cases). The mean volume of polymethyl methacrylate injected in cases with disk leakage was 7.2 mL (15/19 cases), whereas the mean volume injected in cases without disk leakage was 8.1 mL (4/19 cases). Preexisting vacuum phenomenon was present in a disk adjacent to the vertebral body with intraosseous vacuum phenomenon in nine of 19 cases. Eight of these nine occurrences were in the disk immediately adjacent to the vertebral body surface with the intraosseous vacuum phenomenon. No radiographic complications were encountered that required follow-up surgery.
The mean clinical follow-up period for all patients was 9.9 months. Eleven of the 18 patients survived; seven patients died but were followed up until the time of death. The follow-up period for the 11 surviving patients ranged from 6 to 24 months (mean, 13.6 months). In the patients who died, follow-up ranged from 2 days to 14 months (mean, 4.0 months). Pain relief was complete in eight (44.4%), partial in six (33.3%), and unchanged in four (22.2%) of the 18 patients. The patient who died of cancer-related problems within 2 days of the procedure was counted as having no change in pain for purposes of this study.
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Patients with Kümmell's disease, or, more accurately, vertebrae with vacuum phenomena, are generally middle-aged or elderly. The interval between the acute traumatic episode and onset of painful symptoms varies from days to years. The lower thoracic and upper lumbar vertebral bodies are principally involved. Single rather than multiple vertebral levels are usually affected [18]. This pattern of development of the intraosseous vacuum phenomenon suggesting Kümmell's disease was found in our patient population. However, we found that the time interval between trauma and development of the intraosseous vacuum phenomenon was difficult to evaluate accurately. This information could probably be determined only in a large-scale prospective series of patients with acute traumatic vertebral compression fractures who were initially radiographed and who were subjected to regular clinical and radiographic follow-up.
The cardinal radiographic sign of Kümmell's disease, as described in the literature, is the presence of a bandlike radiolucent area in a collapsed vertebral body. This feature is also known as an intraosseous vacuum cleft [15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25]. In rare circumstances, intraosseous gas may accompany a Schmorl's node, but in these cases, the pattern and distribution of the gas differ from that found in Kümmell's disease [18, 28, 29, 30]. In Schmorl's node, a complexly shaped radiolucent area is encountered, with a horizontal component in the disk and a vertical component in the osseous defect [30]. Bhalla and Reinus [24] stated that intraosseous gas had not been described in vertebral osteomyelitis. However, other researchers have reported rare occurrence of intraosseous gas in patients with infection [29]. On MR imaging, the vacuum cleft is seen as a linear area of hypointense signal on T1- weighted images. On T2-weighted images, this area may be either hypointense or hyperintense, depending on positioning of the patient's spine and whether gas or fluid occupies the cleft [18, 25, 31, 32, 33, 34]. Similar MR imaging observations were made in our series.
Percutaneous vertebroplasty can be of great help to patients with acute osteoporotic compression fractures in which pain persists despite correct medical treatment [2, 3, 6, 7, 8, 9, 10, 11, 12]. Typically, this procedure is performed in patients who are not candidates for surgery. An additional advantage of percutaneous vertebroplasty is that it can be performed in multiple vertebrae, either at the same time or with subsequent procedures [4, 5, 6, 8, 9]. Vertebroplasty can also be performed in patients with severe vertebral body collapse [13].
The use of percutaneous vertebroplasty for the treatment of painful fractured vertebrae with intraosseous vacuum phenomena suggestive of Kümmell's disease has not been previously reported in the peer-reviewed literature listed in Index Medicus. To our knowledge, very little histologic data are available in the cases called "Kümmell's disease" to support the claim that osteonecrosis is always present when a vacuum phenomenon is radiographically present in a vertebral body. Hasegawa et al. [25], in a histologic study of the vertebrae of five patients with an intravertebral cleft, found the cleft to be lined with smooth fibrocartilaginous tissue, consistent with pseudarthrosis. These researchers did not find necrotic bone in their histologic material, although one patient had what they described as necrotic granulation at the posterior portion of the pseudarthrosis.
We found that some vertebrae are very soft on needle placement during vertebroplasty, whereas in other cases, the bone of the vertebral body felt distinctly hard. We believe that a fractured vertebral body with an intraosseous vacuum phenomenon represents a poorly healed vertebral body fracture with impending or established nonunion. The adjacent vertebral body may or may not be ischemic; individual cases probably lie within a spectrum that ranges from normal to osteonecrotic. It is likely that these patients have severe pain due to motion between the fracture fragments on either side of the fracture cleft containing the vacuum phenomena. In some cases, we repositioned the same needle or placed an additional needle so that parts of the vertebral body that did not initially fill with polymethyl methacrylate could be filled. We hoped that this maneuver would prevent the vertebral body from undergoing further collapse. None of this patient cohort had evidence of progression of collapse.
Perivertebral venous, paravertebral soft-tissue, and intradiscal leakages are usually of no short-term or midterm clinical significance [5, 6, 8, 9, 10, 13]. It is also our experience that polymethyl methacrylate leakage into the disk is not rare. Our study appeared to show a relationship between the incidence of polymethyl methacrylate disk leakage and the presence of an intraosseous vacuum cleft leading to the adjacent disk. When leakage into the disk was present, it was almost always at the location of the cleft. Lafforgue et al. [26], in a retrospective study of 310 consecutive patients with at least one vertebral collapse, found that intradiscal vacuum phenomenon adjacent to vertebral collapse was common. Collapse-related vacuum phenomena were seen on radiographs in 15% of their patients and in 21% when all the imaging modalities were considered. In a subsequent article, Lafforgue et al. [35] showed a high association between continuous intervertebral and intravertebral vacuum phenomena. In that study, a significantly higher incidence of intradiscal vacuum phenomenon was present in cases of intraosseous vacuum phenomenon compared with the control group, and in six cases, communication between the intervertebral and intravertebral gaseous collections occurred through a fractured endplate. Our findings support this postulation. In nine of 19 of our cases, gas was present in the disk. Of these nine cases, eight occurred in proximity to the vacuum cleft; that is, the vacuum disk existed at the superior disk space with an intraosseous vacuum cleft in the superior aspect of the vertebral body (Figs. 2A, 2B, 2C, 2D and 2E). Therefore, to minimize polymethyl methacrylate leakage into the adjacent disk when performing vertebroplasty in patients with intraosseous vacuum phenomena, close observation of the fluoroscopic image during injection is required.
Pain relief is commonly seen after a mean period of 24 hr after the procedure [8]. Complete pain relief or decreased pain has been reported in as many as 95% of patients with osteoporotic compression fractures [7, 10, 12]. Our study population had similar results: Most of these patients (77.7%) obtained complete or partial pain relief from the procedure. It is not clear why the percentage of patients with complete pain relief in our series is not as high as that reported by other researchers. One possible explanation may be that all our follow-ups were performed by a third party who was not at all related to performance of the procedure. We took this approach to ensure that the results were as objective as possible, with the thought that some patients may say they feel better than they actually do to avoid disappointing the treating doctor. Typically, our patients had improved mobility within 24 hr, and most could bear weight shortly after the procedure. Our typical approach was to have the patient stand and walk 1 hr after the end of the procedure. After vertebroplasty, the amount and type of pain medication could be either greatly reduced or stopped in most patients. In some of our patients, particularly those who were bedridden for longer periods of time, it took a few days for pain relief to be recognized because these patients could not tell the difference between the soreness resulting from the procedure and that of their presenting pain.
The true relationship between the presence of vacuum phenomena and Kümmell's disease remains unclear. Because Lafforgue et al. [26] showed intradiscal vacuum phenomenon adjacent to vertebral collapse to be common, the question arises whether the presence of vacuum phenomenon in the adjacent vertebral body always represents osteonecrosis. A compressed vertebral body commonly fractures through the endplate; therefore, it is possible that the intraosseous gas came from gas in the disk rather than occurring as an isolated development [35]. Some vertebra in our patients felt hard during needle placement, whereas others were soft. Although some evidence of necrotic bone was found by Hasegawa et al. [25], we agree with those researchers that the chief emphasis should be that these intraosseous vacuum phenomena represent vertebral body nonunions or pseudarthroses. We also question the necessity for osteonecrosis to be present before the term "Kümmell's disease" is used because Kümmell [14] did not have histologic proof in any of his cases and his description of Kümmell's disease occurred before the development of radiography.
In summary, percutaneous vertebroplasty is a useful technique for management of painful compression fractures with intraosseous vacuum phenomena, all of which probably represent vertebral body pseudarthroses. On the basis of our experience, percutaneous vertebroplasty is a safe procedure that provides pain relief and vertebral stabilization in most patients with painful fractured vertebra with intraosseous vacuum phenomena.
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