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DOI:10.2214/AJR.07.2186
AJR 2007; 189:W348-W352
© American Roentgen Ray Society


Original Research

Relationship Between Cement Distribution Pattern and New Compression Fracture After Percutaneous Vertebroplasty

Noboru Tanigawa1, Atsushi Komemushi, Shuji Kariya, Hiroyuki Kojima, Yuzo Shomura, Naoto Omura and Satoshi Sawada

1 All authors: Department of Radiology, Kansai Medical University, Hirakata Hospital, 2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan.

Received March 6, 2007; accepted after revision June 12, 2007.

 
Address correspondence to N. Tanigawa (tanigano{at}hirakata.kmu.ac.jp).

WEB This is a Web exclusive article.


Abstract
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Abstract
Introduction
Subjects and Methods
Results
Discussion
References
 
OBJECTIVE. The objective of this study was to prospectively investigate relationships between cement distribution patterns and the occurrence rates of new compression fractures after percutaneous vertebroplasty.

SUBJECTS AND METHODS. Percutaneous vertebroplasty was performed for osteoporotic compression fractures in 76 consecutive patients. Patients were divided into two groups according to the cement filling pattern shown on radiography and CT: cleft pattern group (group C, n = 34), compact and solid cement filling pattern in vertebrae; and trabecular pattern group (group T, n = 42), sponge-like filling pattern. A visual analog scale (VAS) was used to assess pain severity, and anterior and lateral radiographs of the thoracic and lumbar vertebrae were obtained 1-3 days and 1, 4, 10, 22, and 34 months after percutaneous vertebroplasty. Differences in treatment efficacy and the occurrence rates of new compression fractures were examined and compared for both groups using the Mann-Whitney U test and chi-square test.

RESULTS. A significant difference was seen between groups with respect to the volume of cement injected per vertebra (mean volume: group C, 4.5 mL; group T, 3.7 mL; p = 0.01). VAS improvement did not differ significantly between group C (4.6) and group T (4.5). The mean follow-up period was 19.5 months, during which new compression fractures were significantly more frequent in group C (17 of 34 [50%]) than in group T (11 of 42 [26.2%]; p = 0.03).

CONCLUSION. Although cement distribution patterns do not significantly affect initial clinical response, a higher incidence of new compression fractures is seen in patients with treated vertebrae exhibiting a cleft pattern.

Keywords: CT • neuroradiology • percutaneous vertebroplasty • polymethyl methacrylate • radiography • vertebral body fracture • vertebroplasty


Introduction
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
 
Percutaneous vertebroplasty was introduced in the radiology literature in 1987 [1]. Since then, percutaneous vertebroplasty has been performed to treat back pain associated with vertebral body compression fractures that are caused by various diseases and is now widely performed due to its substantial pain-relieving effects. Percutaneous vertebroplasty is a technique that structurally stabilizes a fractured vertebral body through the injection of a self-curing cement substance containing polymethyl methacrylate (PMMA) as the main component. However, some patients return to the hospital because of recurrent back pain after percutaneous vertebroplasty, and such pain is sometimes caused by new compression fractures.

Although a general consensus is lacking regarding the causes of new compression fractures after percutaneous vertebroplasty, new fractures often occur in vertebral bodies adjacent to the vertebral bodies treated by percutaneous vertebroplasty [2-4]. Furthermore, such new compression fractures occur relatively soon after percutaneous vertebroplasty [2] and fractures of adjacent vertebrae occur significantly sooner [5].

We hypothesized that different cement distribution patterns in treated vertebrae affect the frequency of new compression fractures. The purpose of this study was to prospectively investigate relationships between cement distribution patterns and the occurrence rates of new compression fractures after percutaneous vertebroplasty.


Subjects and Methods
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Abstract
Introduction
Subjects and Methods
Results
Discussion
References
 
Patients
This study was approved by our institutional review board. All patients provided written informed consent. This study was performed between March 2003 and February 2004, and the study cohort initially comprised 87 consecutive patients who were scheduled to undergo percutaneous vertebroplasty for vertebral compression fractures (266 vertebrae) resulting from osteoporosis. Eleven patients were excluded from the study, including one patient who died of unrelated disease within 3 months and 10 patients who refused to undergo 1- and 4-month follow-up examinations at our outpatient clinic. The remaining 76 patients (69 women, seven men; mean age, 73.4 years; age range, 44-85 years; 163 vertebrae) were followed for more than 4 months after percutaneous vertebroplasty and constitute the final study population.

The indication for percutaneous vertebroplasty was back pain caused by vertebral body compression fracture with pain on percussion of the vertebral spinous process. In patients with multiple compression fractures in whom percussion pain of the spinous process was unclear, physical examination was performed using fluoroscopy. Patients with back pain attributed to myelopathy or radiculopathy resulting from stenosis of the vertebral canal or narrowing of the intervertebral foramen were excluded.

Before percutaneous vertebroplasty was performed, physical examination, neurologic examination, ECG, respiratory function tests (forced expiratory volume in 1.0 second, percent of forced expiratory volume in 1.0 second, forced vital capacity, percent of forced vital capacity), and laboratory investigations (RBC, WBC, platelet count, prothrombin time, C-reactive protein) were performed. The following diagnostic imaging studies were also obtained: anterior and lateral radiographs of the thoracic and lumbar vertebrae; MR images of the vertebrae, including the vertebrae affected by compression fracture (performed within 1 week of the procedure); and CT scans.

Analysis of Cement Filling Pattern and Patient Classification
Images were evaluated by two neuroradiologists. The neuroradiologists were aware that the patients had undergone percutaneous vertebroplasty for osteoporotic compression fracture. However, they were blinded to specific information, such as the preprocedural MRI findings, amount of bone cement used, approach route, clinical results of the procedure, and other clinical data (including patient history), and reached a consensus for each case.

Vertebral bodies were classified in two groups according to the cement distribution pattern on anterior and lateral radiography of the thoracic or lumbar vertebrae, including treated vertebrae. Classification criteria were as follows: cleft type, vertebrae with compact and solid cement filling; and trabecular type, vertebrae with sponge-like cement filling. Furthermore, on the basis of this classification system, patients were divided into the following two groups: group C, patients with at least one vertebra exhibiting the cleft pattern; and group T, patients with vertebrae exhibiting the trabecular pattern only.

Percutaneous Vertebroplasty Procedure
Percutaneous vertebroplasty was performed under combined CT and fluoroscopic guidance (Advantx LCA plus ACT, GE Healthcare). Thirty minutes before the procedure, 10 mg of morphine hydrochloride (Morphine HCI Inj. 10, Sankyo), 0.5 mg of atropine sulfate (Atropine Sulf. Inj., Tanabe), and 25 mg of hydroxyzine hydrochloride (Atarax-P Inj., Pfizer Japan) were administered intramuscularly. Local anesthetic, 10 mL of 1% lidocaine (Xy-locaine Inj. E, AstraZeneca), was administered from the skin to the periosteum of the pedicle using a 22-gauge needle (Cathelin needle, Terumo Europe) under fluoroscopic guidance.

After the orientation of the puncture needle was confirmed on CT and the puncture needle was aligned with the Cathelin needle, a 13-gauge bone biopsy needle (Osteo-Site Bone Biopsy Needle Murphy M2, Cook) was advanced into the pedicle of the vertebral arch. CT was repeated, and after the orientation of the biopsy needle was confirmed, the visualization technique was changed to lateral fluoroscopy and the bone biopsy needle was advanced to the anterior third of the vertebral body close to midline.

Intraosseous venography was performed with 1-5 mL of iopamidol (Iopamiron 300, Schering Japan) or 10-20 mL of carbon dioxide to confirm that the needle was not positioned in a direct venous anastomosis to the central or epidural veins. Subsequently, 20 g of PMMA powder (Osteobond copolymer bone cement, Zimmer) was mixed with 5 g of barium sulfate powder that had been sterilized with dry heat to increase opacity. PMMA was produced by adding 10 mL of liquid methylmethacrylate monomer to the powder, and then the mixture was blended to a toothpaste-like consistency.

PMMA was injected with lateral fluoroscopic guidance using 1-mL syringes. The PMMA injection was terminated when adequate filling of the vertebral body was achieved or if leakage occurred. If leakage occurred, the needle was repositioned, and additional PMMA was injected to fill the remaining part of the vertebral body. The needle was then removed, and all patients were observed in the supine position for 2 hours after the procedure.

Outcome Evaluation and Postprocedural Management
Pain level was evaluated with a visual analog scale (VAS) of 0-10, with 0 representing no pain and 10 indicating the worst pain. The severity of preprocedural pain was assessed by either the attending physician or the physician who was scheduled to perform percutaneous vertebroplasty on either the day before or the day of percutaneous vertebroplasty. The severity of the postprocedural pain was assessed by either the attending physician or the physician who performed percutaneous vertebroplasty between 1 and 3 days after the procedure.

At our institution, patients are admitted for percutaneous vertebroplasty, and once the procedure is completed, they are returned to their ward and instructed to rest in the supine position for 2 hours. Although patients were allowed to move after that 2-hour period, most patients slept due to the effects of premedication. Thus, the severity of pain after percutaneous vertebroplasty was not assessed on the day of the procedure.

Follow-Up Protocol
At our institution, percutaneous vertebroplasty was performed on an inpatient basis. During postprocedural days 1-3, pain severity was assessed, and frontal and lateral radiography of the thoracic and lumbar vertebrae was performed. In addition, at 1, 4, 10, 22, and 34 months after discharge from the hospital, patients were asked to undergo follow-up at our outpatient clinic, where medical history was recorded, physical examinations were performed, and additional frontal and lateral radiographs of the thoracic and lumbar vertebrae were obtained. Patients were also instructed to return to our institution if they experienced pain, and in such cases, physical examination and radiography were performed; MRI was also performed as necessary.

A new compression fracture was defined as follows: a vertebral body exhibiting reduced height on radiography; or if the height difference was unclear, a vertebral body exhibiting a bone marrow edema pattern on MRI in patients with localized spontaneous pain or pain on percussion of the spinous process. Two radiologists reviewed the imaging findings and arrived at a final diagnosis by discussion if their opinions did not agree.

Statistical Analysis
The degree of VAS improvement in each patient was calculated by subtracting the postprocedural VAS from the preprocedural VAS. Intergroup differences in the degree of VAS improvement were statistically assessed. Among groups C and T, patient age, the volume of cement injected per vertebra, number of treated vertebrae, degree of VAS improvement, and length of time from percutaneous vertebroplasty to the diagnosis of a new compression fracture were compared and analyzed using Wilcoxon's rank sum test. Fisher's exact test was used to analyze patient sex differences, and the chi-square test was used to compare the occurrence rate of new compression fractures. The statistical analyses were conducted using StatView (version 5.0, SAS Institute) for Windows (Microsoft), and p values of < 0.05 were considered statistically significant.

By using pre- and postprocedural standing lateral radiographs, the anterior, middle, and posterior vertebral heights were measured on the basis of the techniques used by McKiernan et al. [6]. The degree of height restoration in each vertebra was calculated by subtracting the preprocedural vertebral height from the postprocedural vertebral height. Intertype differences in the degree of height restoration were statistically assessed.


Figure 1
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Fig. 1A —73-year-old woman with vertebral compression fracture of L1 due to osteoporosis. Lateral radiograph (A) and CT scan (B) show compact and solid cement filling in vertebral body. Vertebra was assigned to type C pattern of cement distribution.

 


Figure 2
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Fig. 1B —73-year-old woman with vertebral compression fracture of L1 due to osteoporosis. Lateral radiograph (A) and CT scan (B) show compact and solid cement filling in vertebral body. Vertebra was assigned to type C pattern of cement distribution.

 


Figure 3
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Fig. 2A —80-year-old woman with vertebral compression fracture of L1 due to osteoporosis. Lateral radiograph (A) and CT scan (B) show sponge-like cement filling in vertebral body. Vertebra was assigned to type T pattern of cement distribution.

 


Figure 4
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Fig. 2B —80-year-old woman with vertebral compression fracture of L1 due to osteoporosis. Lateral radiograph (A) and CT scan (B) show sponge-like cement filling in vertebral body. Vertebra was assigned to type T pattern of cement distribution.

 

Results
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
 
Classification was type C for 40 vertebrae and type T for 123 vertebrae. The locations of the treated vertebrae classified by cement distribution pattern are shown in Table 1. There was an increased incidence of fractures exhibiting cleft pattern at the thoracolumbar junction in our patient population. Accordingly, 34 patients were assigned to group C (Fig. 1A, 1B) and 42 patients were assigned to group T (Fig. 2A, 2B). Of the 34 patients assigned to group C, 27 patients had multiple fractures with types C and T vertebrae (Table 2).


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TABLE 1: Locations of Treated Vertebrae Classified by Cement Distribution Pattern

 

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TABLE 2: Number of Treated Vertebrae of Both Groups

 

Fisher's exact test showed a significant difference in the distribution of patients between groups C and T on the basis of patient sex (p = 0.04). Wilcoxon's rank sum test indicated no significant differences between groups with respect to patient age, the number of treated vertebrae, or the preprocedural VAS. However, a significant difference was seen between the groups with respect to the volume of cement injected per vertebra (p = 0.01, Table 3). VAS improvement, defined as the pre- to postprocedural difference (preprocedural VAS - postprocedural VAS), was 4.6 ± 2.5 (mean pain score ± SD) in group C and 4.5 ± 2.9 in group T. No significant difference between the groups was identified (Table 4).


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TABLE 3: Summary of Patient Data

 

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TABLE 4: Cement Distribution Pattern and Initial Clinical Response as Measured on Visual Analog Scale (VAS)

 

Significant differences were seen between the preprocedural and postprocedural vertebral body heights of the anterior, middle, and posterior areas of both types; however, a statistically significant difference was evident between type C and type T with respect to the degree of height restoration in the middle (p < 0.01) and posterior (p < 0.01) areas (Table 5).


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TABLE 5: Vertebral Body Heights Before and After Percutaneous Vertebroplasty

 

The mean follow-up period was 16.7 months (range, 1-34 months). During the follow-up period, a new fracture was identified in 17 of the 34 patients (50%) with a cleft pattern. Conversely, a new fracture was identified in 11 of 42 patients (26.2%) with a trabecular pattern. A significant difference in the incidence of new fracture was thus seen between the groups (p = 0.03). Moreover, an adjacent fracture was found in 15 of the 34 patients (44.1%) with a cleft pattern and seven of the 42 patients (16.7%) with a trabecular pattern, again representing a significant difference in incidence of new adjacent fracture between groups (p = 0.009).

The mean length of time (± SD) from percutaneous vertebroplasty to new compression fracture was 3.5 ± 3.7 months (range, 1-10 months) for group T and 1.7 ± 1.3 months (range, 1 week-4 months) for group C, representing no significant intergroup differences (p = 0.18).


Discussion
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
 
The volume of cement injected was greater for type C than for type T vertebrae. A cleft indicates a cavity created in a fractured vertebra. Hence, cement could be more easily injected into the cleft of type C vertebrae. The degree of recovery in vertebral height was subsequently greater for type C than for type T in our series.

Between groups C and T, no significant intergroup differences in the degree of early improvement were seen according to VAS. Patient age at fracture onset is one factor affecting the degree of early improvement in VAS. In other words, among patients without cleft patterns, the degree of early improvement in VAS is more favorable for patients with bone marrow edema than for those without bone marrow edema [7, 8]. In the present study, patient age at fracture onset was low for group T, and these patients were more responsive to percutaneous vertebroplasty. Group C patients had cleft patterns, and patients with cleft patterns have been shown to respond well to percutaneous vertebroplasty [9]. In other words, because both groups of patients responded well to percutaneous vertebroplasty, no significant intergroup differences were seen. As we mentioned, a difference in the volume of cement injected was seen between types T and C, with a greater volume of cement injected for type C vertebrae. Hodler et al. [10] and Kaufmann et al. [11] investigated relationships between cement volume and clinical outcome and reported no correlation, agreeing with the results of our study.

A significant difference in incidence of new compression fractures was seen between the two patient groups after percutaneous vertebroplasty, with a higher incidence of new compression fractures in group C. One reason for this higher incidence was that the volume of cement injected per vertebra was greater for type C than for type T. The amount of PMMA is thought to be related to restored height of treated vertebra. We hypothesized that the restored height of a treated vertebra showing a cleft pattern is greater than that with a trabecular pattern. The increased height of the collapsed vertebral body could increase soft-tissue tension around the vertebral body, leading to an increased load on other vertebrae, particularly those adjacent to the vertebra with the original fracture.

Another reason for the higher incidence of compression fractures in group C is that the duration of fracture was higher for group C than for group T. Because vertebral body alignment and the structures around the fractured vertebral bodies, including muscles, had become used to the vertebral fracture, the degree of restoration in vertebral height was greater due to percutaneous vertebroplasty. In other words, rapid alignment restoration may trigger new compression fractures.

Many fractures occurred adjacent to the treated vertebrae for group C. Compression fractures accompanying cleft patterns are known to occur frequently in the thoracolumbar junction [12, 13]. Hence, it is reasonable to assume that new compression fractures frequently occur in the thoracolumbar junction as part of the natural course of osteoporosis, and we cannot conclude that compression fractures are likely to occur adjacent to percutaneous vertebroplasty-treated vertebrae for type C.

In the present study, there were no statistically significant differences in the length of time from percutaneous vertebroplasty to a new compression fracture between groups C and T. Trout et al. [14] reported no marked difference in the length of time from percutaneous vertebroplasty to a new compression fracture between patients with and those without cleft patterns, which agrees with the results of our study.

This study has several limitations. First, we treated an average of two vertebrae per patient, and patients were classified on the basis of the presence of an intraosseous cleft per patient. Ideally, a new fracture would be assessed in patients with single-level vertebroplasty only. If the methods used in this study were used to assess new compression fractures in patients with a single treated vertebra, a closer relationship between the cement distribution pattern and new compression fracture after vertebroplasty might be found. Second, we did not take into account the effects of cement leakage on new compression fractures. Cement leakage into the intervertebral disk is known to be one factor that contributes to new compression fractures, and the incidence of cement leakage, particularly leakage to the intervertebral disk, must be considered.

In conclusion, our results indicate that although the cement distribution pattern after percutaneous vertebroplasty does not significantly affect initial clinical response, a higher incidence of new compression fractures, particularly fractures of adjacent vertebrae, is seen in patients with percutaneous vertebroplasty-treated vertebrae exhibiting a cleft pattern.


References
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
 

  1. Galibert P, Deramond H, Rosat P, Le Gars D. Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty [in French]. Neurochirugie 1987;33 : 166-168[Medline]
  2. Uppin AA, Hirsch JA, Centenera LV, Pfiefer BA, Pazianos AG, Choi IS. Occurrence of new vertebral body fracture after percutaneous vertebroplasty in patients with osteoporosis. Radiology 2003;226 : 119-124[Abstract/Free Full Text]
  3. Grados F, Depriester C, Cayrolle G, Hardy N, Deramond H, Fardellone P. Long-term observations of vertebral osteoporotic fractures treated by percutaneous vertebroplasty. Rheumatology (Oxford)2000; 39:1410 -1414[CrossRef][Medline]
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  5. Trout AT, Kallmes DF, Kaufmann TJ. New fractures after vertebroplasty: adjacent fractures occur significantly sooner. Am J Neuroradiol 2006; 27:217 -223[Abstract/Free Full Text]
  6. McKiernan F, Faciszewski T, Jensen R. Reporting height restoration in vertebral compression fractures. Spine2003; 28:2517 -2521[CrossRef][Medline]
  7. Tanigawa N, Komemushi A, Kariya S, et al. Percutaneous vertebroplasty: relationship between vertebral body bone marrow edema pattern on MR images and initial clinical response. Radiology2006; 239:195 -200[Abstract/Free Full Text]
  8. Brown DB, Glaiberman CB, Gilula LA, Shimony JS. Correlation between preprocedural MRI findings and clinical outcomes in the treatment of chronic symptomatic vertebral compression fractures with percutaneous vertebroplasty. AJR 2005; 184:1951 -1955[Abstract/Free Full Text]
  9. Do HM, Jensen ME, Marx WF, Kallmes DF. Percutaneous vertebroplasty in vertebral osteonecrosis (Kümmell's spondylitis). Neurosurg Focus 1999; 7:e2[Medline]
  10. Hodler J, Peck D, Gilula LA. Midterm outcome after vertebroplasty: predictive value of technical and patient-related factors. Radiology 2003;227 : 662-668[Abstract/Free Full Text]
  11. Kaufmann TJ, Trout AT, Kallmes DF. The effects of cement volume on clinical outcomes of percutaneous vertebroplasty. Am J Neuroradiol 27:1933 -1937
  12. Lane JI, Maus TP, Wald JT, et al. Intravertebral clefts opacified during vertebroplasty: pathogenesis, technical implications, and prognostic significance. Am J Neuroradiol 2002;23 : 1642-1646[Abstract/Free Full Text]
  13. McKiernan F, Faciszewski T. Intravertebral clefts in osteoporotic vertebral compression fractures. Arthritis Rheum2003; 48:1414 -1419[CrossRef][Medline]
  14. Trout AT, Kallmes DF, Lane JI, Layton KF, Marx WF. Subsequent vertebral fractures after vertebroplasty: association with intraosseous clefts. Am J Neuroradiol 2006;27 : 1586-1591[Abstract/Free Full Text]

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