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1 All authors: Mallinckrodt Institute of Radiology, 510 S Kingshighway Blvd., Box 8131, St. Louis, MO 63110.
Received March 14, 2003;
accepted after revision August 4, 2003.
Address correspondence to D. B. Brown
(brownda{at}mir.wustl.edu).
Abstract
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MATERIALS AND METHODS. Our database identified 41 patients with symptomatic fractures more than 1 year old. These patients were categorized into subgroups determined by fracture age: 12 months 1 day24 months (n = 16) or more than 24 months 1 day (n = 25). Changes in pain and mobility for the study group were compared with those in 49 patients with fractures less than 1 year old.
RESULTS. Thirty-three (80%) of the 41 patients in the study group had improvement in painseven (17%) had complete and 26 (63%) had partial relief. Forty-five (92%) of the 49 control group patients had improvement in pain24 (49%) had complete and 21 (43%) had partial relief. The number of patients achieving partial or complete relief of pain was not statistically different between groups (p > 0.05), although complete relief was significantly more frequent in the control group (p = 0.002). Twenty patients (49%) in the study group versus 34 patients (69%) in the control group had improved mobility after vertebroplasty (p = 0.047). Patients with fractures 12 months 1 day24 months old had improvement in mobility similar to that in patients in the control group (p = 0.962). Fractures more than 24 months 1 day old were associated with significantly less improvement in mobility (p = 0.006).
CONCLUSION. Most patients with fractures more than 1 year old will experience clinical benefit from vertebroplasty. Complete relief of pain is more likely when less mature fractures are treated.
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Percutaneous vertebroplasty was performed with sterile technique using a C-arm angiographic unit (Angioskop D 33, Siemens Medical Systems, Erlangen, Germany). Mild to moderate conscious sedation was achieved using a combination of fentanyl citrate (Sublimaze, Abbott Laboratories, North Chicago, IL) and midazolam (Versed, Roche Pharmaceuticals, Manati, PR). After sterile preparation and draping, the area overlying the access site and the periosteum of the lamina posterior to the pedicle were anesthetized.
After a small skin incision, an 11-gauge Jamshidi trochar needle (MDTech, Gainesville, FL) was advanced. Using rotational fluoroscopy, we advanced the needle by the transpedicular approach into the anterior third of the vertebral body. We performed intraosseous venography using 13 mL of iohexol (Omnipaque 180, Nycomed, Princeton, NJ) to exclude direct venous communication, detail venous drainage, and assess vascularity [13]. We repositioned the needle if necessary to opacify trabeculae before filling venous structures.
We mixed the methyl methacrylate powder (Osteobond copolymer bone cement, Zimmer, Warsaw, IN) with 5 mL of sterilized barium sulfate (Zimmer) [14]. The liquid methylmethacrylate monomer was then added to the powder and mixed to toothpastelike consistency. We injected the polymethylmethacrylate mixture in the lateral projection using a series of 1-mL syringes or a 10-mL syringe with a metal adapter [15]. Injection continued until the polymethylmethacrylate reached the posterior quarter of the vertebral body or it started passing into the disk space or paravertebral tissues. If the polymethylmethacrylate reached the contralateral pedicle, we deemed a second needle unnecessary [16]. When filling the vertebral body was thought to be insufficient, we placed a second transpedicular needle (Fig. 1A,1B,1C,1D,1E).
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After the procedure, we obtained follow-up by telephone calls to patients 2 weeks, 1 month, 3 months, 6 months, 1 year, and then annually after the final procedure. Patients were asked if their pain was gone, improved, the same as, or worse than before vertebroplasty. We considered patients with complete elimination of or improvement in pain at the final time to have achieved clinical benefit from percutaneous vertebroplasty. Patients also were asked whether their current level of activity had improved, was the same, or was worse since undergoing vertebroplasty. Forty-one patients had symptoms more than 1 year old; these individuals comprised the study group. No patients were refused treatment on the basis of the duration of symptoms. The study group was further subdivided as to whether symptoms had been present for 12 months 1 day24 months or 24 months 1 day or more. Subgrouping in the study group was performed to further evaluate different fracture ages. As a control, 49 patients with symptoms less than 1 year old who underwent vertebroplasty during the same time period and agreed to follow-up were tracked. These patients were similar in age (study group: mean age = 68 years, range = 4087 years; control group: mean age = 73 years, range = 4488 years), cause of fracture, and percentage of female patients (study group vs control group, 78% vs 70%). We compared complete elimination of pain as well as the total of patients achieving improvement in symptoms after percutaneous vertebroplasty between groups.
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The 49-patient control group underwent 55 vertebroplasty procedures on 98 vertebral levels. Indication for vertebroplasty in this group was osteoporotic compression fracture. In the control group 50 thoracic and 48 lumbar levels were treated as follows: T5 (n = 2), T6 (n = 6), T7 (n = 8), T8 (n = 6), T9 (n = 3), T10 (n = 1), T11 (n = 7), T12 (n = 18), L1 (n = 19), L2 (n = 11), L3 (n = 5), L4 (n = 10), and L5 (n = 3). The mean number of procedures per patient was 1.1, and the mean number of levels treated was 2.0. The six patients who underwent multiple procedures had the second vertebroplasty a mean of 3.7 and median of 4 months after the first procedure. Three of these patients had pain relief with development of new fractures. These values were not significantly different from the study group. No complications of significance occurred in either group.
All patients were treated within 1 month of their most recent imaging study. Followup in the study group ranged from 6 to 28 months with mean and median durations of 15.8 and 12 months, respectively. Follow-up in the control group ranged from 4 to 27 months with mean and median durations of 13.2 and 12 months, respectively. No patients in either group were lost to follow-up.
Changes in pain and mobility after percutaneous vertebroplasty in both groups are outlined in Table 1. No patients in either group described worsening of their pain. In the study group, seven (17%) of the 41 patients reported complete eradication of pain, although 26 (63%) had improvement after vertebroplasty. Clinical benefit was present in 33 (80%) of the 41 patients in the study group. Compared with the control group patients, significantly fewer patients in the study group had complete relief of pain (p = 0.002). The difference between the study group and the control group in achieving clinical benefit was not statistically significant (p > 0.05). Subgroup analysis showed a significantly greater proportion of patients achieving complete pain relief in the control group than in the group with fractures 12 months 1 day24 months old (p = 0.010) or in the group with fractures 24 months 1 day old or older (p = 0.016). The proportion of patients achieving clinical benefit was not significantly different in any fracture age group. Even though fractures more than 1 year old were less likely to be pain-free after percutaneous vertebroplasty, 80% of patients still reported improvement or eradication of pain.
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Twenty patients (49%) in the study group had improved mobility after percutaneous vertebroplasty compared with 34 (69%) in the control group. The difference between groups was statistically significant (p = 0.047). Patients in the group with fractures 12 months 1 day24 months old had an increase in mobility similar to the control group patients (p = 0.962). In patients with fractures 24 months 1 day old or older, the improvement in mobility was statistically worse than in the control group (p = 0.006).
All three patients in the study group with a decrease in their baseline activity had fractures that were 3 years old or older. One patient had developed new lower spine radiculopathy requiring epidural steroid injection several months after percutaneous vertebroplasty at a level separate from her vertebroplasty. She reported an improvement of her pain at the percutaneous vertebroplasty site before the steroid injection. A second patient had a knee injury after vertebroplasty that was the cause of her limited activity. The pain at her vertebroplasty site had completely disappeared. The third patient had worsening of her chronic obstructive lung disease that limited her mobility.
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Previous authors have pointed out that the duration of conservative therapy and the timing of vertebroplasty after fracture vary widely among studies [12]. The significance of fracture age relevant to treatment success remains undefined. Considering the low complication rate and high efficacy of vertebroplasty in other trials, it is reasonable to treat chronic fractures in this patient group with limited available options. Additionally, because vertebroplasty is still coming of age in the United States, patients with long-standing symptoms are likely to be referred as treatment becomes regionally available and physician awareness of percutaneous vertebroplasty increases.
Our success at improving or completely eliminating pain (80%) is similar to many reports based on acute fractures and in keeping with other publications [2, 46, 16, 21]. Cotton et al. [1] stated that 90% of patients would experience relief after treatment of osteoporotic compression fractures. In the current study, clinical benefit was greater in the subgroup with fractures that were 12 months 1 day24 months old than for fractures 24 months 1 day or older (87% vs 76%, respectively). Zoarski et al. [3] tracked long-term results as they treated 30 patients with follow-up of 1518 months. These researchers found vertebroplasty to be durable over longterm follow-up with 96% of the patients satisfied with the result of the treatment. The clinical benefit described in this study was at final follow-up in all patients.
Other groups of researchers have anecdotally described poor results after treatment of fractures more than 6 [11] or 12 [10] months old. There remains a relative paucity of peer-reviewed data in patients with chronic pain. Barr et al. [6] reported complete elimination of symptoms in 63% of their patients 48 hr after treatment. Many patients in that trial had "well-documented pain and fractures more than 2 years old." The study by Kaufmann et al. [12] is closest to ours in terms of patient population. The mean fracture age in the trial of these researchers was 19 weeks, and follow-up was 1 month after treatment. Kaufmann et al. reported a significant improvement in pain and mobility for the entire patient group. Fracture age was not independently associated with symptom relief after vertebroplasty, which mirrors our findings. A number of complementary differences between the two trials exist. Our study includes a control group to evaluate relative efficacy to our study group. The median fracture age (28 months) in this trial indicates fractures are more chronic and the follow-up is longer (mean, 15.8 months) than in the other study. Nevertheless, both studies show considerable benefit to patients treated with this technique, justifying treatment of patients with pain from chronic fractures.
Our data show that most older fractures respond to vertebroplasty, although there may be fewer complete responses. Clinical benefit is still present in 76% of fractures that are 24 months 1 day old or older, although treatment success is less than that with less mature fractures. Overall improvement in mobility was similar with less acute fractures, having a trend toward greater mobility. Many of our patients had fractures diagnosed at an outside institution by physicians unaware of the procedure, and patients were referred as their pain persisted and treating clinicians became aware of the procedure. The lesser improvement in pain and increase in mobility in patients with older fractures suggest that the disabling spiral that starts with ineffectual conservative treatment has long-term adverse outcomes even after vertebroplasty. Results were positive enough that we believe percutaneous vertebroplasty is an effective treatment for persistent pain related to chronic fractures. However, treating patients earlier is still preferable because they are more likely to have complete eradication of pain and may retain more mobility.
This study has some weaknesses. One is its retrospective nature. A separate weakness is the absence of a formal validated questionnaire, which might have provided more quantitative information.
The findings of this study show that chronic vertebral compression fractures can be safely and efficaciously treated with percutaneous vertebroplasty. Although the quantity of pain relief and improvement in mobility may be slightly lower than in the acute fracture setting, measurable improvement in symptoms was noted in 80% of treated patients.
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