Publications
APS Bulletin • Volume 13, Number 4, 2003
Innovations in Practice
Norman Harden, MD, Department Editor
Vertebroplasty and Kyphoplasty: A Comprehensive Review
Allen W. Burton, MD, and Ehud Mendel, MD
Vertebroplasty and kyphoplasty are relatively new techniques used to treat painful vertebral compression fractures (VCFs). Vertebroplasty is the percutaneous injection of a vertebral body with bone cement, generally polymethylmethacrylate (PMMA).
PMMA has been used in orthopedics since the late 1960s (Charnley, 1970). Percutaneous vertebroplasty (PV) was first reported by a French group in 1987 for the treatment of painful hemangiomas (Gailbert, Deramond, Rosat, Le Gars, 1987). More recently, a variety of groups have advocated expanding PV indications to include osteoporotic compression fractures, traumatic compression fractures, and painful vertebral metastasis (Jensen et al.,1997; Deramond, Depriester, Toussaint, & Gailbert, 1997; Kaemmerlen et al., 1989). The mechanism of action is unknown, but it is postulated that fracture stabilization leads to analgesia.
Kyphoplasty is a modification of PV. It involves the percutaneous placement of balloons (called “tamps”) into the vertebral body. An inflation/deflation sequence creates a cavity prior to cement injection. Percutaneous kyphoplasty (PK) may restore vertebral body height and reduce the kyphotic angulation of the compression fracture prior to PMMA injection (Lieberman, Dudeney, Reinhardt, & Bell, 2001).
Vertebral Compression Fractures (VCFs)
Osteoporotic fractures are prevalent in elderly women, with an annual estimate of 1.5 million fractures in the United States alone. These include 700,000 VCFs, 250,000 hip fractures, 250,000 colles fractures, and 300,000 fractures of other limbs. The annual cost of these fractures in the United States was estimated at $5 to $10 billion in 1995, and more recently estimated at $13.8 billion (Riggs & Melton, 1995; Truumees, 2001). VCF has been defined as at least a 15% decrease in vertebral body height. The prevalence of VCF in women age 50 and older has been estimated at 26% (Silverman, 1992). The prevalence increases with age, reaching 40% among 80-year-old women (Melton et al., 1989). Cooper and colleagues noted 84% of VCFs were associated with pain (Cooper, Atkinson, O’Fallon, & Melton, 1992). Fracture pain usually lasts 4 to 6 weeks, with intense pain at the fracture site. Chronic pain often occurs when one level is greatly collapsed or multiple levels are collapsed.
A large prospective cohort study revealed that elderly women with VCFs had a higher age-adjusted mortality rate than the cohort without VCFs. Kado and colleagues (1999) reported a prospective cohort study following 9,575 women age 65 and older for a mean follow-up of 8.3 years (Kado et al., 1999). Mortality was proportional to the number of compression fractures. Annual mortality rose from 19 per 1,000 women-years in those without VCF, to 44 per 1,000 women-years in those with five or more fractures. Increased mortality was primarily due to pulmonary causes or cancer. Schlaich and colleagues (1998) showed a significant decrease in pulmonary function test parameters, namely vital capacity (VC) and forced expiratory volume in 1 second (FEV1), in patients with VCFs versus an age-matched group with chronic low back pain (Sclaich et al., 1998).
The clinical consequences of VCF include loss of height, exaggerated thoracic kyphosis with lumbar lordosis, with associated pulmonary difficulties (Silverman, 1992). Loss of mobility and decreased exercise tolerance are common, with associated chronic depression that may worsen the chronic back pain associated with the deformity.
When treating patients with osteoporosis, several treatment caveats are important. A systemic disease requiring systemic treatment, it is beyond the scope of practice for most interventional specialists. Patients are typically managed by their primary care physician or an endocrinologist. Calcium supplements, vitamin D, hormone replacement therapy, selective estrogen replacement modulators, bisphosphonates, and intranasal calcitonin are pharmacologic treatments often used alone or in combination (Khosla & Riggs, 1995). The importance of weight-bearing exercise and fall precautions should always be emphasized.
Patient Selection
Ideal PV and PK candidates have mostly activity-related axial pain corresponding to the level of a recent compression fracture. This pain lessens or goes away completely with recumbancy and/or sitting still. Many clinicians use tenderness over the appropriate level as an indicator for PV or PK. Recently, however, Gaughen and colleagues (2002) analyzed data on 90 patients undergoing PV. They identified 10 patients with no preoperative tenderness. Subgroup analysis of these 10 patients reveals excellent outcomes; consequently, these authors argue for a careful evaluation of history and MRI and bone scan findings, but they do not make pain on palpation a necessary requirement for PV (Gaughen et al., 2002).
A complete neurologic exam and recent radiographic imaging is mandatory. Magnetic resonance imaging (MRI) will show an increased T-2 signal due to bone edema at the level with a recent fracture. Bone scans have also been used to target the most recent fracture(s) in patients with multiple fractures (Maynard et al., 2000). Cord compression on MRI (in the absence of neurologic findings) is a relative contraindication. If there is a suspicion of a posterior cortical fracture on MRI, a CAT scan (CT) will reveal more details of the bony architecture. Plain spine radiographs may reveal pedicle anatomy to help plan the procedure. For example, small pedicle cases may favor PV with a smaller needle, versus the larger trochar used with PK procedures.
General Tenets/Contraindications
Prior to the procedure, patients should not take any anticoagulants and their coagulation profile should be normal. Their platelet count should be at least 100,000 at the time of the procedure. Sepsis and active infection are contraindications. The authors recommend waiting 2 weeks after infection treatment to minimize infectious risks.
Informed consent should include lack of pain relief, osteomyelitis, fracture of the vertebra or pedicle, extravasation of cement into the spinal canal or neural foramen, paralysis or nerve root damage, and venous embolism. The need for open surgery should also be discussed with patients.
Vertebroplasty patients are often elderly and frail. This population tolerates vertebroplasty without difficulty, but many patients would have significant morbidity with vertebrectomy and spine stabilization surgery. Patients must be informed of the risks, which include neurological deficits that may require emergent surgical intervention due to cement extravasation (paralysis or nerve damage). Severely debilitated patients may decide not to proceed with open repair.
Procedural Technical Aspects
Vertebroplasty and kyphoplasty require clinicians to be trained in spinal anatomy, fluoroscopic imaging, and the use of these techniques to perform interventional procedures. Currently, interventional pain specialists, neurosurgeons, orthopedic surgeons, and interventional radiologists perform these procedures.
The procedure should be performed in a sterile OR suite that will allow fluoroscopic imaging of the thoracolumbar spine. Biplanar or C-arm fluoroscopy of good quality is mandatory for maximal safety. A radiolucent table is mandatory, as is appropriate padding for prone slightly flexed positioning. Other necessary materials include local anesthetic solution (the authors use a 50:50 mixture of 1% lidocaine with 0.25% bupivacaine), PMMA material, and barium or other radioopacification material. Some groups advocate tobramycin powder. Eleven-gauge or 13-gauge bone biopsy needles with connection tubing and cement injection syringes are needed. Many commercial kits are available.
General anesthesia or monitored anesthesia care (MAC) may be used. If MAC is used, the surgeon must use generous amounts of local anesthetic, especially onto the periosteum, where much nociception occurs. Some patients experience discomfort with advancement of the trochars across the posterior cortical margin, with balloon inflation (in the case of kyphoplasty), and with PMMA injection. The anesthesiologist must be prepared to “deepen” the MAC during these phases of the procedure. Consider individual patients when choosing the type of anesthesia. Anxious or nervous patients may have a better experience with a general anesthetic. Carefully pad the pressure points of these fragile patients.
Some clinicians proceed directly with injection of PMMA after obtaining uni- or bipedicular vertebral body access, while others prefer to do venography prior to cement injection. In theory, venography provides anatomic knowledge of large venous channels’ proximity to the trochar. This information increases precision for clinicians injecting the PMMA. If a small amount of contrast injection reveals a direct spread into a venous channel, for example, the operator may move the trochar prior to injection or carefully inject relatively solidified PMMA to embolize the large vein prior to injecting more PMMA into the vertebral body. The literature reveals variable efficacy of the use of venography (Gaughen et al., 2002; McGraw, et al., 2002; Vasconcelos, Gailloud, Beauchamp, Heck, & Murphy, 2002). The authors use venography in cases in which a metastatic tumor is located near the posterior cortical margin. The authors do not routinely use venography in cases of osteoporotic fracture.
Clinicians inject PMMA into the vertebral body after careful imaging that confirms the location of the trochar or trochars into the anteromedial portion of the vertebral body (Figure 1). The PMMA should be opacified and begin to harden to the consistency of toothpaste prior to injection. Injection can be accomplished with small syringes filled with PMMA or with one of several commercially available kits. The injection must be administered under live lateral or biplanar fluoroscopic guidance. If PMMA goes into a blood vessel or toward the posterior cortical margin, it must be halted immediately. The authors halt cement injection when it spreads to the posterior one-third of the vertebral body. Radiographs taken before and after a patient’s vertebroplasty procedure are shown in Figures 2a and 2b.
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Figure 1. Anteroposterior fluoroscopic image of bipedicular trochar placement for percutaneous verebroplasty 
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Figure 2a. Anteroposterior and lateral radiograph of L2 osteoporotic compression fracture. 
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Figure 2b. Anteroposterior and lateral radiograph of L2 compression fracture postvertebroplasty. 
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Outcomes
There have been many retrospective review and prospective outcome case series studies. Many good open label trials are reviewed below. To our knowledge, no randomized controlled trials of PV versus conservative treatment have been conducted. With such good clinical outcomes in PV and PK, such a trial may be difficult to conduct as patients and clinicians would be unenthusiastic about being randomized to the conservative treatment arm. However, other designs including a delayed treatment arm (unless the patient’s symptoms improve) may be pragmatic. There are no controlled trials comparing PV and PK.
PV in Osteoporotic VCFs
Zoarski and colleagues (2002) performed a prospective analysis of 30 patients undergoing PV at 54 levels for osteoporotic VCFs with follow-up out to 18 months. Their predominately female patients had a mean age of 79. Patients were evaluated with an instrument called the MODEMS (musculoskeletal outcomes data evaluation and management scale—an unvalidated scale described in this study). Significant improvement was noted in pain and disability (p < 0.0001), physical function (p = 0.0004), and mental function(p = 0.0009). These improvements were seen by 2 weeks and were durable to 18 months follow-up. One patient suffered an asymptomatic epidural PMMA leak.
McGraw and colleagues (2002) prospectively evaluated 100 patients undergoing PV for osteoporotic VCFs. These patients underwent 156 levels of PV, 68 thoracic and 88 lumbar, during a 35-month period. Among patients, 97% reported significant pain relief at 24 hours sustained out to a mean follow-up of 21 months. The VAS pain scores dropped from 8.9 to 2.0 post-procedure (p < 0.0001). Nearly all patients (93%) noted an increased activity level. They had two complications, including a sternal fracture and a transient radiculopathy.
Cortet and colleagues (1999) prospectively evaluated 16 patients undergoing PV for osteoporotic VCFs. These patients underwent 20 levels of PV. Pain scores significantly improved (VAS and McGill) by a mean of 56% by Day 3 (p < 0.0005 and p < 0.005, respectively), and this was sustained out to day 180. The Nottingham Health Profile improved significantly in the dimensions of pain (p < 0.01), physical mobility (p < 0.05), emotional reactions (p < 0.05), social isolation (p < 0.05), and energy (p < 0.05). There were no complications, nor any further VCF, and improvements were sustained out to a 6-month follow-up.
Perez-Higueras and colleagues (2002) prospectively assessed clinical and radiographic outcomes in 12 patients during a 5-year period. Initial VAS pain scores of 9.1/10 fell to 2.1/10 on the third day post-procedure, and 2.2/10 at 5 years (p < 0.001). The McGill pain questionnaire results showed significant improvement after treatment (p < 0.001), with significant pain relief still noted at the 5-year follow-up (p < 0.001). All patients were “very” or “somewhat satisfied” with the procedure. Three patients had four new fractures during the 5-year follow-up period, two of which were adjacent to treated levels. CT revealed cement in the epidural veins of 48% of patients, but only one patient had transient neuritis.
Grados and colleagues (2000) provided insight into long-term outcomes with a long-term retrospective follow-up analysis. PV was performed on 40 patients between 1990 and 1996 for osteoporotic VCFs. In 1997, the patients were asked to return for reevaluation. The mean duration of follow-up was 48 months post-PV. Pain scores (Huskisson’s VAS) decreased from 8.0/10 pre-procedure to 3.7/10 at 1-month follow-up and 3.4/10 at maximal follow-up (p < 0.05). There were no complications, but researchers found a slightly increased risk of VCF in adjacent vertebra to the treated level. The odds ratio of a fracture in the vicinity of a treated level was 2.27 (95% CI 1.1-4.6) versus 1.44 (95% CI 0.8-2.6) in a remote location to the treated level. The authors concluded PV is a safe and effective procedure to treat focal back pain secondary to osteoporotic VCF.
Barr and colleagues (2000) performed a retrospective review of 47 patients during 3 years treated with PV at 84 vertebral levels. Among the patients, 38 had osteoporotic VCFs, eight had primary or metastatic tumor-related VCFs, and one had a hemangioma. Patients’ pain was rated on a 0-10 numerical rating scale, most having pain at or near 10 prior to the procedure. Among the 38 patients with osteoporosis, 63% had marked pain relief with post-procedural scores of 0 to 3, 32% had moderate pain relief with post-procedural scores of 4 to 6, and 5% had no change. No statistical analysis was provided. In the group with tumor-related VCF, only 50% had significant pain relief. The patient with the hemangioma had no pain relief. Three patients had minor complications.
PK in Osteoporotic VCFs
Lieberman and colleagues (2001) conducted a prospective open label phase I trial of PK for osteoporotic VCFs. Thirty patients underwent 70 levels of PK for painful osteoporotic VCFs. SF-36 scores showed significant change for bodily pain (p = 0.0001) and physical function post-procedure (p = 0.002). Most (70%) patients had restoration of an average of 47% of lost vertebral body height. There was an 8.6% rate of asymptomatic PMMA leakage.
Ledlie and Renfro (2003) reported a large retrospective review of 96 patients who underwent PK at 133 levels mainly for osteoporotic VCFs. The mean patient age was 76, and 70% were female. The mean pre-procedure pain score was 8.6/10, 2.7/10 (VAS scale, p < 0.0001) in the near post-procedure period, and 1.4/10 at the 1-year follow-up mark. Most patients’ activity levels dramatically improved. PK often restores vertebral body height; in this cohort, the mean anterior vertebral body height increased from 65% of normal pre-procedure height to 90% of normal height at 1-month post-procedure.
Outcomes in Cancer
Fourney and colleagues (2003) at University of Texas MD Anderson Cancer Center in Houston, TX, reported a retrospective review of 56 patients undergoing 65 PV and/or 32 PK procedures for cancer-associated VCFs. Among patients in this group, 21 had myeloma and 35 had other primary and metastatic neoplasms. The mean age was 62, with a mean duration of symptoms of 3.2 months. Most patients (84%) reported marked or complete pain relief post-procedure, with a mean follow-up of 4.5 months on a VAS scale (p = 0.02, Wilcoxin signed rank test). There were no treatment-related complications. Asymptomatic PMMA leakage was noted in 9.2% of 65 levels treated with PV, but there was no PMMA leakage in the PK group. These authors presented an algorithm for choosing PV, PK, surgery, or radiotherapy in cancer patients.
Dudeney and colleagues (2002) prospectively evaluated a series of patients with multiple myeloma undergoing PK for painful VCFs. Among the group, 18 patients underwent 55 PK procedures for multiple myeloma. SF-36 scales showed post-procedure improvement for the bodily pain, physical function, vitality, and social functioning scales (p = 0.0001). On average, 34% of lost vertebral height was restored. Major complications were not observed, and asymptomatic PMMA leakage was seen in 4% of treated levels.
Wang and colleagues at University of Texas MD Anderson Cancer Center in Houston, TX, (2002) reported our experience with myeloma patients in abstract form. A retrospective analysis of 32 patients undergoing 43 PV and 24 PK procedures was undertaken. Most patients (91%) reported marked or complete pain relief post-procedure. The mean pre-procedure (11-point numeric rating scale 0-10) NRS pain score was 7/10, and the postoperative mean pain score was 2/10, which was durable to a 12-month follow-up period (p < 0.005). Major complications were not seen, but asymptomatic PMMA extravasation was noted in 4% of patients undergoing PV.
Outcomes in Special Circumstances
As experience grows with these techniques, various groups are pushing the envelope on indications for the procedure. There are some preliminary data/case series on efficacy in patients with radicular pain, traumatic burst fractures, severe VCF/vertebral plana, cervical spine pathology, and intra-operative PMMA augmentation of pedicle screw fixation spinal stabilization (Chung, Lee, Kim, & Lee, 2002; Nakano et al., 2002; Peh, Gilula, & Peck, 2002; Wetzel, Martin, Somon, Wilhelm, & Rufenacht, 2002; Sarzier, Evans, & Cahill, 2002.)
Complications
Complications are rare but can be serious—the exact incidence is unknown. PMMA can flow out of the vertebral body posteriorly into the spinal canal or neural foramina, or anteriorly into the paraspinous veins with systemic consequences. There are case reports of nerve root and spinal cord compression from extravertebral PMMA (Lee, Lee, & Yoo, 2002; Ratliff, Nguyen, & Heiss, 2001). Several reports of minimally symptomatic pulmonary emboli, one case of cardiovascular collapse requiring pulmonary embolectomy, and one case of paradoxical cerebral arterial PMMA emboli have been reported (Jang, Lee, & Jung, 2002; Tozzi et al., 2002; Scroop, Eskridge, & Britz, 2002). The literature suggests less PMMA leak with PK versus PV (Phillips, Wetzel, Lieberman, & Campbell-Hupp, 2002). The clinical significance of this is uncertain. As further studies are completed, a more complete risk-benefit ratio can be defined.
Conclusions
PV and PK are newer, minimally invasive techniques used to treat painful VCFs. There is a growing body of evidence—albeit comprising limited-quality, predominately open-case series—that indicates this procedure is efficacious in alleviating the pain associated with VCF. The results of the procedure in numerous reports are uniformly good. There are, however, a growing number of case reports with serious complications.
It will be difficult to conduct the randomized controlled trials (RCTs) needed to compare short- and long-term outcomes of PV and/or PK versus more conservative therapies. These procedures have gained such widespread popularity that patients would undoubtedly resist being randomized to the conservative treatment group. Blinding would be impossible, as pain relief is usually dramatic and prompt. A study to evaluate PV versus conservative treatment will likely need to be conducted in a rigorous, multi-centered fashion with a delayed treatment group that would be eligible for PV if conservative treatment fails after a period of perhaps 3 to 6 months. Other studies are needed to randomly compare PV and PK in various disease states. Early studies are under way to evaluate biologic materials for spinal injection rather than acrylic (PMMA). Despite of the need for more research, PV and PK have shown great promise in the treatment of painful VCFs due to a variety of pathologic states.
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Allen Burton, MD, is associate professor and section chief of pain management in the department of anesthesiology at the University of Texas MD Anderson Cancer Center, Houston, TX. Ehud Mendel, MD, is associate professor and codirector of the spine program, department of neurosurgery, at the same facility.
Please direct your comments or suggestions about this article or department to Norman Harden, MD, Innovations in Pratctice Department Editor, at nharden@rehabchicago.org.