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DOI:10.2214/AJR.06.0542
AJR 2007; 188:634-640
© American Roentgen Ray Society

Original Research

Importance of Intravertebral Fracture Clefts in Vertebroplasty Outcome

Matthew C. Wiggins1,2, Mehrdad Sehizadeh1,3, Thomas K. Pilgram1 and Louis A. Gilula1

1 All authors: Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 S Kingshighway Blvd., Campus Box 8131, St. Louis, MO 63110.
2 Present address: Lancaster Radiology Associates, Lancaster, PA.
3 Present address: Advanced Diagnostic Imaging, Belleville, IL.

Received April 19, 2006; accepted after revision August 1, 2006.

 
Address correspondence to L. A. Gilula.


Abstract
Top
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
OBJECTIVE. The importance of filling intravertebral fracture clefts with polymethylmethacrylate during percutaneous vertebroplasty to maximize stabilization of fracture fragments has been emphasized in the literature. The purpose of this study was to determine whether patients with a single compression fracture with an intravertebral cleft have better outcome after percutaneous vertebroplasty than do patients with a compression fracture but no cleft.

MATERIALS AND METHODS. A retrospective study was conducted to review 354 consecutive percutaneous vertebroplasty procedures on 694 compression fractures. Patients were excluded from consideration if they were treated for metastatic compression fracture or if they were treated at more than a single vertebral body level. Sixty-five patients met the inclusion criteria. Preprocedure radiographs and MR images were reviewed with specific attention to the presence or absence of intravertebral gas or fluid. Images obtained at the procedure also were reviewed for the presence or absence of an intravertebral cleft. Imaging findings were correlated with subjective pain scores immediately, 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years after the procedure.

RESULTS. Thirty-one (48%) of the 65 patients had evidence of a fracture cleft. Twenty-seven patients had opacification of an intravertebral fracture cleft at percutaneous vertebroplasty, and four patients had an intravertebral cleft on preprocedure imaging but did not have cleft opacification. Thirty-four (52%) of the patients had no evidence of a fracture cleft and had only a trabecular pattern of opacification. Although there was a trend toward a greater failure rate in patients with a filled cleft, there was no statistically significant difference in subjective pain scores between the groups.

CONCLUSION. Pain relief with vertebroplasty is similar in patients with and those without intravertebral fracture clefts. Because of the small number of unfilled fracture clefts in our population, the true incidence of post-percutaneous vertebroplasty pain in patients with an un-filled cleft remains uncertain.

Keywords: interventional radiology • spine • vertebroplasty


Introduction
Top
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Intravertebral fracture clefts have been reported as an important sign in vertebral compression fractures since Kummell [1] first described delayed posttraumatic vertebral collapse in 1895. The intravertebral vacuum cleft was defined by Maldague et al. [2] in 1978 as a sign of ischemic vertebral collapse characterized by a gas-density cleft within a transverse separation of the vertebral body. The intravertebral cleft sign has subsequently been correlated with pathologic findings and findings on MRI [3-7]. Fracture clefts have been associated more commonly with benign compression fractures [5] but can be seen in some malignant lesions [6, 8]. On MRI, intravertebral fracture cleft has been described as a linear discrete focus of marked T2-weighted hyperintensity within a vertebral compression fracture [3]. Clefts on contrast-enhanced MR images have been described as cleft-shaped unenhanced areas within the vertebral body [7]. It has been suggested that intravertebral fracture cleft results from vacuum release of gas within cracks in the subchondral bone after vertebral fracture and that the phenomenon probably represents an ununited fracture [2, 9]. It is presumed that the gas-filled cleft subsequently fills with fluid; the result is the characteristic MRI appearance [10, 11]. Histologic analysis of intravertebral fracture clefts has confirmed the presence of serous fluid and necrotic granulation tissue [4, 11]. In addition, intravertebral instability has been documented at the location of fracture clefts [12], and motion along the fracture line is associated with onset of back pain [4]. Finally, surgical stabilization of fracture clefts may relieve pain [13].


Figure 1
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  		Fig. 1A —71-year-old woman with vertebral compression fracture after fall. Frontal (A) and lateral (B) radiographs of lumbar spine show loss of vertebral body height and linear well-demarcated radiolucency characteristic of intravertebral fracture cleft (arrows).

 


Figure 2
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  		Fig. 1B —71-year-old woman with vertebral compression fracture after fall. Frontal (A) and lateral (B) radiographs of lumbar spine show loss of vertebral body height and linear well-demarcated radiolucency characteristic of intravertebral fracture cleft (arrows).

 


Figure 3
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  		Fig. 1C —71-year-old woman with vertebral compression fracture after fall. Axial CT scan at level of A and B shows intravertebral gas.

 
Percutaneous vertebroplasty with polymethylmethacrylate (PMMA) cement has gained wide acceptance as a treatment option for patients with painful vertebral compression fractures [14-18], including those with intravertebral fracture clefts [19, 20]. Despite the lack of placebo-controlled trials, percutaneous vertebroplasty has been used in the management of painful osteoporotic and malignant vertebral compression fractures and in painful spinal hemangioma [19-39]. Intravertebral fracture clefts are frequently seen in patients undergoing percutaneous vertebroplasty [12, 19, 20]. It has been suggested that preprocedure imaging is not sensitive in the detection of these clefts, and often the clefts are seen only during injection of cement [20].

Lane et al. [20] reported a trend toward greater pain relief in patients with clefts opacified at percutaneous vertebroplasty. Complete filling of intravertebral fracture clefts with PMMA cement has been advocated to maximize stabilization of the vertebral body [20]. Anecdotal evidence at our institution supports the theory that stabilization of a vertebral fracture cleft with cement may relieve pain. A few patients who have undergone percutaneous vertebroplasty at other institutions have had pain relief after repeated percutaneous vertebroplasty at the same vertebral level at our institution when an intravertebral cleft formerly not filled was found to fill at retreatment. The purpose of this study was to determine whether patients who underwent filling of intravertebral fracture clefts had more favorable outcome of percutaneous vertebroplasty than patients without clefts.


Materials and Methods
Top
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Selection Criteria
Approval for this retrospective study was obtained from the institutional review board at our institution for all vertebroplasty patients between July 25, 2002, and April 23, 2004. All patients included in this follow-up study gave informed consent before participation. In this time period, 354 percutaneous vertebroplasty procedures were performed on a total of 694 compression fractures. Nearly all of the patients underwent vertebroplasty for management of persistent pain not responsive to conservative therapy after a minimum 6-week waiting period to see whether fractures would heal without vertebroplasty. Rare exceptions to this rule were made for patients who needed hospitalization for pain management, patients who became psychotic because of pain medication, and patients confined to bed because of pain who had the potential of developing pneumonia owing to the recumbent position. In all cases, the decision to perform vertebroplasty was made by the attending radiologist in conjunction with referring physicians, surgeons, and physiatrists after review of clinical and radiographic data.

Patients were excluded from consideration for this study if they were treated for compression fractures secondary to metastatic disease or multiple myeloma. To simplify evaluation of postprocedure pain, patients were also excluded from consideration if they were treated at more than a single vertebral level or if they were subsequently treated for new painful compression fractures. After the exclusions, 65 patients (15 men, 50 women; age range, 31-96 years; mean age, 72 ± 12 [SD] years), were selected for inclusion in the study (Table 1).


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  		TABLE 1: Characteristics of Sample Population (n = 65)

 

All available preprocedure radiographs, CT scans, and MR images were reviewed by two of the authors with specific attention to the presence or absence of an intravertebral cleft. Cases of disagreement or question were resolved by consensus of all medically trained authors. On radiography and CT, intravertebral cleft was defined as a linear, well-demarcated focus of intravertebral fluid or gas attenuation (Fig. 1A, 1B, 1C). On MRI, intravertebral cleft was defined as a linear well-demarcated focus of T2 prolongation similar to that of adjacent CSF (Fig. 2). Signal void on T2- and T1-weighted images, which is characteristic of gas, was also considered an intravertebral cleft. Fluoroscopic spot radiographs of the spine immediately before and during percutaneous vertebroplasty were reviewed. An intravertebral cleft was defined on fluoroscopy as a linear well-demarcated focus of fluid or gas attenuation within the vertebral body as shown on routine radiography (Fig. 3A). Postprocedure fluoroscopic images were reviewed to classify the pattern of cement opacification. Immediate dense filling of a geographic intravertebral cavity was classified as cleft opacification (Figs. 3B and 3C). Less dense opacification tracking along intravertebral trabeculae in a nongeographic distribution was characterized as trabecular opacification. Patients were separated into three groups: those who had cleft opacification, those who had no indication of a cleft on preprocedure imaging or during fluoroscopy and had no cleft opacification, and those who had a fracture cleft on preprocedure imaging or during fluoroscopy but did not have cleft opacification at percutaneous vertebroplasty.


Figure 4
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  		Fig. 2 —69-year-old woman with osteoporotic vertebral compression fracture. Sagittal T2-weighted MR image shows well-demarcated focus of T2 hyperintensity similar to that of adjacent CSF and characteristic of intravertebral fracture cleft (arrows).

 

Figure 5
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  		Fig. 3A —81-year-old man with vertebral compression fracture after lifting garage door. Lateral fluoroscopic spot radiograph before injection of cement shows subtle radiolucency indicative of fracture cleft (arrows).

 

Figure 6
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  		Fig. 3B —81-year-old man with vertebral compression fracture after lifting garage door. Fluoroscopic spot radiograph after injection of cement shows immediate characteristic opacification of cleft with dense filling of geographic, well-demarcated intravertebral cavity (arrows).

 

Figure 7
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  		Fig. 3C —81-year-old man with vertebral compression fracture after lifting garage door. Frontal fluoroscopic spot radiograph shows cleft (arrows) extending across vertebral body remains well demarcated.

 

Percutaneous Vertebroplasty Procedure
All procedures were performed in the presence of a board-certified musculoskeletal radiologist. Most of the procedures were performed by one of the authors. The patients were interviewed before the procedure to determine the exact site of pain. Clinical examinations were performed with fluoroscopy to aid in precise pain localization. The patients were placed in the prone, slightly oblique position on the fluoroscopy table. With increasing experience, positioning the patient to produce hyperextension of the spine to try to increase vertebral height became routine. Percutaneous vertebroplasty was performed under strict sterile conditions with fluoroscopic guidance. The procedure was performed in the usual manner, described in detail by Shimony et al. [39]. Cement was injected until it reached the posterior one fourth of the vertebral body or until there was leakage outside the vertebral body. If there was pre-dominant filling of only one side of the vertebral body, a second needle was used to enter the contralateral pedicle. The procedure was repeated to achieve filling of most of the vertebral body.

Outcome Evaluation
Patients were asked to rate their pain level immediately before the procedure using a visual analog scale of 0-100, zero meaning no pain and 100 indicating the worst possible pain. At discharge after percutaneous vertebroplasty, the visual analog scale level was rechecked. The pain level was then evaluated with a follow-up telephone questionnaire approved by the local institutional review board (Appendix 1). The calls were made by a research assistant not involved in the vertebroplasty procedure 2 weeks, 1 month, 3 months, 6 months, 1 year, and 2 years after the procedure. The patients were asked whether pain was absent, improved, the same, or increased compared with the pain before the procedure. The follow-up questionnaire was completed in this manner because many patients had difficulty using the visual analog scale in person or over the telephone.


APPENDIX 1 : Vertebroplasty Follow-Up Questionnaire

Table 4

This study did not have a completely longitudinal structure because many of the patients had incomplete data and because the telephone follow-up approved by the institutional review board started well after vertebroplasty had been introduced at our institution. Sixteen patients had pain scores for all six follow-up times, six patients had pain scores for five of the times, four patients had pain scores for four times, nine patients had pain scores for three times, 14 patients had pain scores for two times, 10 patients had pain scores for one time, and six patients had no pain scores for any of the follow-up times. Of the six patients with no follow-up information, five had died and one was lost to follow-up. The five deaths were not related to vertebroplasty.

Statistical Analysis
Data were analyzed with contingency tables of cleft outcome versus reported pain by time. Because the sample size was relatively small, patterns were tested for statistical significance after combination of the pain categories gone and better and the categories same and worse. Patterns were tested for statistical significance with Fisher's exact tests. Analysis was performed with JMP 5.0 (SAS Institute).


Results
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 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
Preprocedure radiographs were available for review for 58 of the 65 patients, MR images for 48, and CT scans for 18. Fluoroscopic images obtained during the procedure were reviewed for all patients. Twenty-seven patients were found to have cleft opacification at percutaneous vertebroplasty, and 34 patients to have no cleft opacification. In four cases, preprocedure images showed intravertebral fracture, but no opacified cleft was found at percutaneous vertebroplasty. The filled cleft and no cleft groups had nearly identical sex distributions. Twenty-one (78%) of the 27 patients in the filled cleft group and 25 (74%) of the 34 patients in the no cleft group were women (p = 0.7, chi-square). Patients in the no cleft group (mean age, 68 years) tended to be younger than those in the filled cleft group (mean age, 76 years) (p = 0.0007, Student's t-test), and there was greater variability in their age. The age range of the no cleft group was 31-96 years (SD, 14 years) versus 51-91 years (SD, 9 years) for the filled cleft group.

Overall, there was a large decrease in numeric pain score immediately after the procedure, from a mean of 69.7 to a mean of 15.8. The differences in pain scores between cleft outcomes were trivial both before (filled cleft mean, 64.8; unfilled cleft mean, 60.0; no cleft mean, 74.6; p = 0.23, analysis of variance) and immediately after treatment (filled cleft mean, 14.2; unfilled cleft mean, 18.8; no cleft mean, 16.6; p = 0.92, analysis of variance). Most of the patients also reported relief of pain on follow-up (Table 2).


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  		TABLE 2: Change in Pain

 

Although there was a trend toward less pain relief in patients with filled clefts compared with patients without clefts, this difference did not approach statistical significance (p > 0.15 in all cases, Fisher's exact test). Only four patients had unfilled clefts, and they had a maximum of three reports at any follow-up time point, so it is impossible to generalize from these data beyond observing that there were no reports of worse pain.

In the cases of 21 (78%) of the 27 patients with cleft opacification at percutaneous vertebroplasty, fluoroscopic spot views obtained during the procedure before injection of cement showed an intravertebral cleft (Table 3). Preprocedure MR images were available for review for 23 of the 27 patients, and the images of 13 (57%) of the patients showed a cleft. Preprocedure radiographs of the spine were available for review for 25 patients, and these images showed only 11 (44%) of the patients had a cleft. Preprocedure radiographs and MR images were available for review for 22 patients, and only seven (32%) of these patients were found to have a fracture cleft on both studies. CT examinations available for review for eight patients showed that five (62.5%) of the patients had clefts. Three patients with cleft opacification at percutaneous vertebroplasty did not have an intravertebral cleft on any preprocedure images or during fluoroscopy.


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  		TABLE 3: Imaging of Patients with Cleft Opacification at Percutaneous Vertebroplasty

 


Discussion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
Intravertebral fracture clefts have long been recognized in the imaging literature, and opacification of fracture clefts often occurs during percutaneous vertebroplasty [12, 19, 20]. Fracture clefts have been histopathologically correlated with areas of necrosis and fibrocartilaginous tissue [4] and have been called vertebral pseudarthroses. McKiernan and Faciszewski [12] anecdotally reported similar pathologic findings in bone obtained at vertebroplasty, suggesting that clefts seen at vertebroplasty are at least similar to the clefts seen on MRI or radiography. If intravertebral fracture clefts have the imaging appearance of vertebral pseudarthroses, it seems logical that filling of the cleft with cement would maximize stabilization and result in pain relief. However, to our knowledge, there has been no reported difference in outcome among patients with a filled cleft compared with those without a cleft [20]. Despite this lack of differentiation, the importance of filling intravertebral fracture clefts during percutaneous vertebroplasty has been emphasized in the literature [12, 20, 40].

Our data indicate a trend toward less pain relief in patients with a filled cleft compared with patients with no cleft. These findings may be explained by the preferential filling of intravertebral clefts during percutaneous vertebroplasty. As mentioned in the literature, vertebral fracture clefts often easily opacify without specific redirection of the needle into the cleft [40]. If there is predominant filling of the cleft, it is possible that the remaining vertebral body will remain unsupported and untreated, causing further pain, especially if there is further collapse of the unfilled part of the treated vertebral body. It has been suggested that filling the vertebral cleft alone may not be adequate in some patients [41]. Wagner and Baskurt [41] described one case in which a vertebral body refractured with anterior extrusion of cement after filling of a large intravertebral cleft during percutaneous vertebroplasty. Of our four patients who had a cleft on preprocedure imaging but did not have cleft opacification, none returned with increased pain. Although it is difficult to generalize from so few patients, it seems that some clefts that do not initially opacify with cement may be stabilized effectively without filling of the cleft with PMMA.

Studies [12, 20] have shown that preprocedure imaging is not sensitive in detection of all clefts seen at percutaneous vertebroplasty, and our data support this finding. MRI depicted only 57% (13/23) of clefts opacified at percutaneous vertebroplasty. The most sensitive technique in detection of clefts was fluoroscopy performed at the procedure, which showed 78% (21/27) of clefts. This success is likely secondary to widening of the cleft with extension of the spine during positioning for percutaneous vertebroplasty, a maneuver that was performed on our patients with increasing frequency as our experience with vertebroplasty increased. Fracture clefts have been shown to change in appearance with changing position [10]. As suggested by McKiernan and Faciszewski [12], the insensitivity of imaging may also be related to the time it takes for cleft margins to become more defined after fracture.

Limitations of this study stemmed from the retrospective nature of this type of analysis. The study was not completely longitudinal because many patients had incomplete data. The lack of data at some of the earlier time points was related to the use of a questionnaire approved by the institutional review board well after the introduction of vertebroplasty. In addition, many of our patients experienced difficulty with use of the visual analog scale over the telephone during follow-up interviews. We elected to use a simpler scale of pain score, which has not been proven in clinical studies. Patients were asked to remember pain that they had had as long as 2 years previously, a difficult task in the best of circumstances. Finally, in an attempt to simplify outcome, our population was limited to a subset of patients treated at only a single vertebral level. Patients who returned for subsequent fracture treatments also were excluded. These exclusions may have produced a population with a particularly favorable post-percutaneous vertebroplasty outcome, masking potential differences. These exclusions also decreased the total number of patients, limiting the power of statistical analysis. Because of the small number of unfilled fracture clefts in our population, the true incidence of persistent pain after nonfilling of a fracture cleft is unknown.

In summary, intravertebral fracture clefts have long been described in the literature and are often identified in patients with intractable back pain who undergo percutaneous vertebroplasty. Preprocedure MRI and preprocedure radiography are not sensitive in consistent detection of clefts seen at the procedure, and most commonly clefts are visualized during fluoroscopy before cement injection. Often the clefts easily opacify with PMMA without direction of the needle into the cleft. There is no reported difference in outcome among patients who have filled clefts compared with those without clefts, although we identified a tendency toward more frequent failure in patients with a filled cleft than in those with no cleft.


References
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS