Publications
APS Bulletin • Volume 15, Number 3, Summer 2005
Innovations in Practice
Debra Gordon, MS RN, Department Editor
Vertebroplasty and Kyphoplasty for Percutaneous Vertebral Compression Fractures
Sean D. Christie, MD FRCSC, John K. Song, MD, and Richard G. Fessler, MD PhD
Background
Osteoporosis, the progressive loss of bone matrix and demineralization, is the most common metabolic bone disorder, affecting more than 28 million Americans (Ray, Chan, Thamer, & Melton, 1997). Not only does osteoporosis weaken bones, but it can also lead to the development of fractures (Riggs & Melton, 1986). Treatment of vertebral compression fractures using opioids can occasionally result in opioid dependence. In a predominantly elderly population, this can alter mood and mental status, thus compounding the patient’s condition (Silverman, 1992). Vertebral compression fractures, most commonly caused by osteoporosis and metastatic disease, are a significant cause of morbidity and mortality in people 80 years old and older (Kado et al., 1999). Decreased lung capacity, chronic pain, sleep deprivation, depression, decreased mobility, and loss of independence are all possible sequelae of vertebral compression fractures (Cook et al., 1993; Gold, 1996; Schlaich et al., 1998).
The risk of developing vertebral compression fractures increases with age. For example, vertebral compression fractures affect slightly less than 25% of women under the age of 50. After a patient reaches 80 years of age, however, there is an abrupt increase in incidence to 40%–50% (Cooper, Atkinson, O’Fallon, & Melton, 1992; Lyles, 1999; Melton, 2003). Vertebral compression fractures do not only occur in females. Olszynski et al. (2004) found that vertebral compression fractures occur in approximately 40% of males 80 years old and older. Additional risk factors for developing vertebral compression fractures include menopause, prolonged immobilization or immobility, chronic steroid therapy, diabetes mellitus, rheumatoid arthritis, cirrhosis, renal insufficiency, and malnutrition (Rao & Singrakhia, 2003). The economic impact of osteoporosis is substantial. The estimated cost of osteoporotic bone fractures within the United States in 1995 was approximately $746 million (Ray, Chan, Thamer, & Melton, 1997).
Percutaneous vertebroplasty and kyphoplasty were developed in the mid-1980s as treatment options for vertebral compression fractures. Percutaneous vertebroplasty is a procedure that allows doctors to stabilize vertebrae damaged by compression fractures by injecting bone cement into the collapsed vertebrae. The aim of percutaneous vertebroplasty is to improve the strength and stability of the injured vertebrae and to eliminate pain. With kyphoplasty, an inflatable bone tamp is used to create a cavity in the bone and to reduce the required injection pressure of the bone cement. Kyphoplasty is a modification of the technique that was developed in the late 1990s (Garfin, Yuan, & Reiley, 2001). It was originally touted as being able to restore vertebral body height and lower the injection pressure of the bone cement. See Figure 1.
Both treatments have similar results, and both treatments are used in the management of percutaneous osteoporotic compression fractures and spinal metastases. This article is a summary of the indications, complications, and outcomes for both percutaneous vertebroplasty and kyphoplasty.
Natural History
A patient diagnosed with osteoporosis-induced vertebral compression fracture is at much higher risk for developing future vertebral compression fractures. Ross, Davis, Epstein, and Wasnich (1991) examined how bone mass density and a history of vertebral compression fractures may be used to predict a patient’s potential susceptibility to developing future fractures (Ross et al). After a mean follow-up of 4.7 years, they concluded that a patient with either (a) a bone mass less than 2 standard deviations from the mean or (b) an average bone density and one prior vertebral compression fracture has a 5-fold increase in risk for developing vertebral compression fractures. A history of two or more vertebral compression fractures increases the risk 12-fold. A patient with a bone mass in the 33rd percentile and two or more fractures has a 75-fold increase in risk for developing future fractures compared to patients with a bone density above the 67th percentile and no prior vertebral compression fractures.
Conservative Management
Conservative treatment for acute vertebral compression fracture can take two forms. One means of conservatively treating vertebral compression fractures includes adequate analgesics and bed rest. Bed rest accelerates bone loss, however, and increases the risk of developing deep venous thromboses (Convertino, Bloomfield, & Greenleaf, 1997; Uhthoff & Jaworski, 1978). The alternative approach is a course of physical therapy and bracing designed to minimize the deleterious effects of immobilization. Regardless of which approach is implemented, approximately two-thirds of patients with acute symptomatic fractures improve after 4–6 weeks (Lieberman & Reinhardt, 2003).
A number of adjunctive medical treatments studied for long-term treatment of osteoporosis and vertebral compression fracture have had mixed results.
Biphosphonates, calcitonin, parathormone, and raloxifene have been shown to reduce subsequent fracture rates, whereas calcitriol, etidronate, fluoride, and pamidronate have yielded mixed and inconclusive results (Lippuner, 2003).
In a prospective, nonrandomized trial of osteoporotic patients with acute vertebral compression fractures, Diamond, Champion, and Clark (2003) found that percutaneous vertebroplasty provided a rapid and significant reduction in pain and an improvement in physical activity scores compared to conservative medical treatment and concluded that it is a viable treatment option. See Figure 2.
Patient Evaluation and Selection
All patients need a detailed neurological history and examination documenting any radiculopathy and motor and sensory function before treatment is administered. Preoperative lab work should include routine blood work and coagulation studies. If malignancy is suspected, an appropriate diagnostic workup is warranted. Radiological evaluation begins with anteroposterior (AP) and lateral radiographs of the spine. A thin-slice computed tomography is used to evaluate the integrity of the posterior cortex. If the posterior cortex is fractured, there may be an increased risk of cement extrusion into the spinal canal during the procedure. If there is evidence on physical examination of neurologic deficit or a suggestion of soft tissue within the spinal canal on imaging studies, a magnetic resonance imaging scan is useful to further delineate any spinal cord compression.
If conservative treatment fails to alleviate pain associated with vertebral compression fractures, we turn to vertebroplasty and kyphoplasty. Although we do not have hard-and-fast rules to deem the failure of conservative treatment, we select patients whose pain from vertebral compression fractures has lasted more than 6 weeks but less than 1 year—although other healthcare providers have successfully treated painful fractures present for 2 years (Barr, Barr, Lumley, & McCann, 2000).
Guidelines and reviews have been published to aid in the selection of patients (McGraw et al., 2003; Stallmeyer, Zoarski, & Obuchouski, 2003). Painful osteoporotic and osteolytic fractures without myelopathy should constitute the vast majority of cases. Contraindications for vertebroplasty include severe wedge deformity with loss of more than 90% of vertebral height (vertebra plana), comminuted burst fracture, spinal canal compromise greater than 20%, epidural tumor extension, myelopathy, inability to lie prone, uncorrected coagulopathy, inability to localize the source of pain, allergy to cement or radio-opaque dye, and infection (local or systemic). See Figure 3.
There has been considerable debate about the merits of prophylactic vertebroplasty in selected patients (McGraw et al., 2003; Stallmeyer et al., 2003). Since a large number of patients never develop clinical symptoms, it is our practice to only treat symptomatic patients. We also arrange to have facilities available to perform emergency decompressive surgery if extravasation of bone cement into the spinal canal occurs, causing myelopathy.
The indications for treating the patient with kyphoplasty mirror those for vertebroplasty, but fracture reduction has not proven reliable. Although the age of the fracture affects the success rate, the exact timing for fracture reduction has yet to be determined (Phillips, 2003; Stallmeyer et al., 2003). In addition, technical considerations require at least 8 mm of residual vertebral height to introduce the materials (Stallmeyer et al.).
Complications
Overall complication rates with vertebroplasty are in the range of 1%–2% for osteoporotic fractures and 5%–10% for metastatic lesions (Mathis & Wong, 2003; McGraw et al., 2003). The most common complication following vertebroplasty is a transient increase in pain at the injected level. This is readily treated with nonsteroidal anti-inflammatory medications and typically resolves within 48 hours (McGraw et al, 2003). Acute radiculopathy has been reported to occur in up to 5% of cases. The symptoms are often transient, and a short course of steroids may be helpful. In some cases, surgical decompression is necessary. The relatively higher complication rate in malignancy is now well recognized (McGraw et al.). Chiras, Depriester, Weill, Sola-Martinez, and Deramond (1997) reported on a series of vertebroplasty cases and documented a complication rate of 1.3% in osteoporotic compression fractures, whereas higher complication rates were noted with more destructive bone lesions, such as hemangiomas (2.5%) and vertebral malignancies (10%).
Cement leakage is a common problem, particularly in lytic lesions (Mathis & Wong, 2003) and has been reported in up to 30%–70% of cases. Fortunately, most of these occurrences are asymptomatic (Cortet et al., 1997). Other reported complications include fractures of the rib or pedicle, pneumothorax, spinal cord compression, and infection. There have been rare reports of serious complications, such as pulmonary embolism and death, occurring during or shortly after vertebroplasty (Childers, 2003; Jensen et al., 1997; Padovani, Kasriel, & Peretti-Viton, 1999; Yoo, Jeong, & Lee, 2004). The causes of these events have not been delineated. It has been postulated, however, that cement with low viscosity and a large number of levels treated at a single sitting may play a role (Mathis & Wong).
Fracture of adjacent vertebral levels following vertebroplasty does occur. The cause is most likely multifactorial and may include the diffuse nature of the osteoporotic disease, relief of pain with a subsequent return to higher level of physical activity, and increased strength in vertebrae that are subject to increased loads from kyphotic deformity. Lin, Ekholm, Hiwatashi, and Westesson (2004) reviewed their series of patients treated with vertebroplasty for compression fractures. They concluded that cement leakage into adjacent disc spaces was related to an increased rate of adjacent level fracture (Lin et al.). Gradual increase in activity and continued use of orthotic devices (for 6 weeks following vertebroplasty) may help prevent adjacent level fracture in those at high risk.
No complications related to balloon tamps have been reported during kyphoplasty procedures (Garfin et al., 2001; Lieberman, Dudeney, Reinhardt, & Bell, 2001). Several complications, all related in some way to needle insertion, have been documented. During phase 1 testing of an inflatable bone tamp, Lieberman et al. found kyphoplasty was to be a safe procedure: there were no significant complications related to their device. Cement extravasation was the most common problem, occurring in 8.6% of their patients (Lieberman et al.). There were no clinical sequelae resulting from cement extravasation. Furthermore, they were encouraged that rates of cement extravasation during their kyphoplasty procedures were lower than those of published vertebroplasty series.
Both the patient and the treating team must consider the exposure to ionizing radiation. Mehdizade et al. (2004) evaluated the radiation dose received by operators in a series of 11 cases. They noted significant radiation dosage measurements, particularly on the operators’ hands. Kruger and Faciszewski (2003) made a similar observation, but they were able to demonstrate that proper shielding, and limiting the radiation used significantly reduced the measured exposure.
Outcomes
There are no randomized, controlled trials comparing the outcomes of vertebroplasty and kyphoplasty to each other or to conservative medical therapies. Most of the data available are derived from retrospective studies, although there have been a few reports on prospective data.
Vertebroplasty can reduce pain in 90%–95% of patients suffering osteoporotic vertebral fractures (Barr et al., 1999; Deramond, Depriester, Galibert, & Le Gars, 1998). Additionally, improvements in mobility and in activities of daily living occur. Also of note, patients who have undergone percutaneous vertebroplasty decrease their use of opioid pain medications. Furthermore, the reduction in pain is rapid, usually within 48–72 hours (Phillips, 2003). The analgesic effect has been shown to persist in a group of patients followed prospectively for a minimum of 5 years (Perez-Higueras, Alvarez, Rossi, Quinones, & Al-Assir, 2002). The success rate is slightly less in patients with metastatic disease, with approximately 65%–80% reporting significant improvement in pain scores (Cortet et al., 1997; Mathis & Wong, 2003).
Lieberman et al. (2001) reported the results of a phase 1 clinical trial examining the efficacy of kyphoplasty in osteoporotic fractures. They reported that in 70% of vertebral levels operated, a mean restoration of 47% of the lost vertebral body height was achieved. In addition, the patients demonstrated a significant improvement in measures of pain, activity, and energy. Similar results have been reported in patients with multiple myeloma (Dudeney, Lieberman, Reinhardt, & Hussein, 2002).
Conclusions
Percutaneous vertebroplasty and kyphoplasty provide minimally invasive options for the management of vertebral compression fractures. These techniques provide substantial pain relief and support without sacrificing mobility (as with conventional bed rest), and they have an acceptable complication rate. Clinical trials need to be done comparing these various approaches for different indications so that we will be able to best direct the care of our patients.
We also must scrutinize the cost effectiveness of any new treatment. Kyphoplasty is significantly more expensive than vertebroplasty. To justify the additional cost, we must show that kyphoplasty is safer and provides added clinical benefits, such as greater stability, better pain relief, or reduced operating time. Most published studies demonstrate equivalent results in stability and pain relief, as well as in complication rates. In addition, both procedures use a similar technique and appear roughly equivalent technically. Therefore, at this time, it seems reasonable to question the cost-benefit ratio of the kyphoplasty procedure compared to vertebroplasty.
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Sean D. Christie, MD FRCSC, is Spine Fellow in the section of neurosurgery at The University of Chicago.
John K. Song, MD, is Spine Fellow in the section of neurosurgery at The University of Chicago.
Richard G. Fessler, MD PhD, is Professor and the Chairman of the section of neurosurgery at The University of Chicago.
Please direct your comments or suggestions about this article or department to Debra Gordon, MS RN, Department Editor, at db.gordon@hosp.wisc.edu