The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 88, Issue 8

Selected Instructional Course Lecture | August 01, 2006

Minimally Invasive Techniques for the Treatment of Osteoporotic Vertebral Fractures

Neil A. Manson, MD, FRCSC¹; Frank M. Phillips, MD¹

¹ Rush University Medical Center, 1725 West Harrison Street, Suite 1063, Chicago, IL 60612. E-mail address for F.M. Phillips: frank.phillips@rushortho.com

View Disclosures and Other Information

Look for this and other related articles in Instructional Course Lectures, Volume 56, which will be published by the American Academy of Orthopaedic Surgeons in February 2007:

• "Spine Surgery for Lumbar Degenerative Disease in the Elderly and Osteoporotic Patient," by Robert A. Hart, MD, MA, and Michael A. Prendergast, BA

The authors did not receive grants or outside funding in support of their research for or preparation of this manuscript. One or more of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (Kyphon Inc.). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Printed with permission of the American Academy of Orthopaedic Surgeons. This article, as well as other lectures presented at the Academy's Annual Meeting, will be available in February 2007 in Instructional Course Lectures, Volume 56. The complete volume can be ordered online at , or by calling 800-626-6726 (8 a.m..-5 p.m., Central time).

An Instructional Course Lecture, American Academy of Orthopaedic Surgeons

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2006 Aug 01;88(8):1862-1872

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Extract

The National Osteoporosis Foundation has estimated that more than 100 million people worldwide are at risk for the development of fragility fractures secondary to osteoporosis. In the United States, the lifetime risk of fractures of the spine, hip, and distal part of the radius is up to 40% for women and 13% for men over the age of fifty years. This leads to an estimated 700,000 osteoporotic vertebral body compression fractures each year, of which more than one-third become chronically painful1. Vertebral compression fractures occur in 20% of people over the age of seventy years and in 16% of postmenopausal women2. Not surprisingly, vertebral compression fractures account for a large portion of the more than $17 billion of annual direct costs associated with osteoporotic fractures in the United States3.

Figures in this Article

Osteoporotic Vertebral Fractures

Epidemiology

The National Osteoporosis Foundation has estimated that more than 100 million people worldwide are at risk for the development of fragility fractures secondary to osteoporosis. In the United States, the lifetime risk of fractures of the spine, hip, and distal part of the radius is up to 40% for women and 13% for men over the age of fifty years. This leads to an estimated 700,000 osteoporotic vertebral body compression fractures each year, of which more than one-third become chronically painful¹. Vertebral compression fractures occur in 20% of people over the age of seventy years and in 16% of postmenopausal women². Not surprisingly, vertebral compression fractures account for a large portion of the more than $17 billion of annual direct costs associated with osteoporotic fractures in the United States³.

Consequences

Osteoporotic vertebral compression fractures are a leading cause of disability and morbidity in the elderly^4-6. The consequences of these fractures include pain, progressive vertebral collapse with resultant spinal kyphosis, and systemic manifestations.

The pain associated with acute vertebral compression fractures may be incapacitating. In a number of cases, the pain subsides over a period of weeks or months, but it is not uncommon for the pain to become chronic⁷. Chronic pain after vertebral fracture may result from (1) incomplete vertebral healing with progressive osseous collapse, (2) altered spine kinematics as a consequence of spinal deformity, or (3) the development of a pseudarthrosis at the involved vertebra. Chronic pain associated with vertebral compression fractures often leads to impaired quality of life and depression^7,8.

Kyphotic deformity in the osteoporotic spine may also create a biomechanical environment favoring additional fractures. The kyphotic deformity shifts the patient's center of gravity anteriorly, creating greater flexion bending moments around the apex of the kyphosis, which increase the kyphotic angulation further and promote additional fractures^9-12. Clinical natural history studies have shown that the risk of a new vertebral fracture in the first year after an incident of vertebral compression fracture increases five to twenty-five times above baseline^13-15, with the vertebra adjacent to the previously fractured level at particular risk^16,17. Many patients with fractures and kyphosis begin doing less because they fear falls and new fractures. This inactivity in turn leads to accelerated osteoporosis and muscle deconditioning⁷. Because of the kyphotic deformity, paraspinal muscles must exert more force to maintain an erect posture. This prolonged exertion can cause backaches and muscle fatigue. Extreme kyphosis places unusual amounts of strain on the ligaments and other soft tissues. Pressure on the lower rib cage near the pelvic rim can produce substantial loin pain and tenderness¹⁸. Prevention of progressive kyphotic deformity or correction of existing deformity may therefore be important both to reduce the risk of fracture at adjacent levels and to prevent the consequences of spinal kyphosis.

Vertebral compression fractures have been shown to adversely affect quality of life, physical function, mental health, and survival^7,8,19-22. These effects are related to the severity of the spinal deformity and are partly independent of pain^7,19. In recent years, researchers have highlighted the impaired pulmonary function that is associated with osteoporotic vertebral compression fractures and spinal deformity^23,24. Leech et al. reported a 9% decrease in pulmonary vital capacity for each thoracic vertebral fracture²³. Kyphosis can lead to reduced abdominal space with poor appetite and resultant nutritional problems^7,25. By shifting the patient's center of gravity forward, kyphotic deformity not only increases the risk of additional fractures²⁶, but also may lead to poor balance, which increases the risk of accidental falls^10,27. In addition to the morbidity associated with vertebral compression fractures, there is an increased mortality rate for older women with vertebral compression fractures compared with that for agematched controls, as found in a prospective study²⁸. The mortality rate was related to pulmonary problems, and it increased with the number of vertebrae fractured.

Nonoperative Management

Traditionally, acute vertebral compression fractures have been treated nonoperatively except in rare cases in which the fracture is associated with neurologic compromise or advanced spinal instability. In fact, an unknown number of vertebral compression fractures produce no or only slight symptoms and are not seen for acute medical attention. Nonoperative measures for some symptomatic vertebral compression fractures fail as a result of intolerable pain, deformity, loss of function, or a combination thereof. Open spinal surgery in patients with osteoporosis is fraught with complications because these patients are often of advanced age and frequently have comorbidities and because of the difficulty of securing fixation in osteoporotic bone. Thus, in the past, most patients with painful vertebral compression fractures have been treated with bed rest, analgesic medications, bracing, anti-osteoporotic drugs, or some combination thereof^18,29-31. Although these treatments can be successful, anti-inflammatory and narcotic medications are often poorly tolerated by elderly patients and may predispose them to confusion, an increased risk of falls, and gastrointestinal side effects. Bed rest can lead to an overall physiologic deconditioning and acceleration of bone loss. Bracing is typically poorly tolerated by older patients, is expensive, and may further restrict diaphragmatic excursion. Furthermore, none of these treatments reduces the fracture or corrects the spinal deformity.

Minimally Invasive Interventions

Orthopaedic fracture care emphasizes restoration of anatomy, correction of deformity, and preservation of function. The treatment of osteoporotic vertebral compression fractures ideally should address both the fracture-related pain and the kyphotic deformity. In addition, this should be accomplished without subjecting the elderly patient to inordinate risks or surgical trauma. Vertebroplasty and kyphoplasty are two minimally invasive surgical interventions offering promising results for this patient population.

Definitions

Vertebroplasty: Percutaneous injection of a bone-filler, typically polymethylmethacrylate, directly into a fractured vertebral body with use of fluoroscopic guidance. The goals of vertebroplasty are pain relief and prevention of further collapse of the fractured vertebra. It may be possible to achieve some postural reduction of certain fractures.

Kyphoplasty: Percutaneous insertion of an inflatable bone tamp into a fractured vertebral body with use of fluoroscopic guidance. Inflation of the bone tamp elevates the end plates to restore the vertebral body closer to its original height while creating a cavity to be filled with bone-void filler, usually polymethylmethacrylate. The goals of kyphoplasty are pain relief, restoration of vertebral body height, and reduction of kyphotic deformity.

Indications

Vertebroplasty and kyphoplasty are indicated for the treatment of painful osteoporotic vertebral fractures, painful vertebrae due to metastasis, multiple myeloma, Kümmell disease, and painful vertebral hemangioma^32-38. In addition, kyphoplasty may be indicated to correct severe and progressive kyphosis resulting from a vertebral compression fracture^32,36,39.

The contraindications to both procedures include systemic pathological conditions such as sepsis, prolonged bleeding times, or cardiopulmonary conditions that preclude the safe completion of the operations. Relative contraindications include vertebral bodies with deficient posterior cortices and neurologic signs or symptoms related to the vertebral fracture. Certain burst or vertebra plana fracture configurations pose technical challenges, and the feasibility of vertebroplasty or kyphoplasty should be cautiously assessed. Treating more than three vertebral levels in one operative setting is not advocated because of the potential for deleterious cardiopulmonary effects related to polymethylmethacrylate monomer and/or fat or polymethylmethacrylate embolization to the lungs.

The benefits of prophylactic reinforcement of vertebrae "at risk" for fracture remain unproven. Finite element modeling suggested a high potential for complications given the volume of polymethylmethacrylate required for a vertebroplasty to successfully reinforce a vertebra at risk for fracture⁴⁰.

Outcomes and Complications

Vertebroplasty

Reports on the outcomes of vertebroplasty have suggested that a majority of patients experience partial or complete pain relief within seventy-two hours after the procedure^18,41-49. As reported in the literature, 60% to 100% of patients overall have noted decreased pain after vertebroplasty^44,48, and improved functional levels and a reduced need for analgesic medication have been reported as well^46,48,50-53. Zoarski et al. administered the Musculoskeletal Outcomes Data Evaluation and Management Systems (MODEMS) scale before and at two weeks after vertebroplasty in thirty patients and found improvement in all four modules of the scale (treatment score, pain and disability, physical function, and mental function)⁵⁴. Similarly, improvement in the Nottingham Health Profile scores have been observed after vertebroplasty⁴². Grados et al., in a longer-term follow-up study in which twenty-five (of forty) patients were evaluated at a mean of forty-eight months after treatment of osteoporotic vertebral compression fractures with vertebroplasty, reported that the mean score for pain, as measured on a 100-point visual analogue scale, decreased from 80 before the vertebroplasty to 37 one month after it⁵⁵. These results remained stable over time, with a pain score of 34 at the time of final follow-up. Published reports have noted a low complication rate after vertebroplasty. Most complications result from extra-ertebral leakage of polymethylmethacrylate causing spinal cord or nerve root compression or pulmonary embolism^18,41-49.

Disease-specific questionnaires have further validated the success of vertebroplasty. Utilizing the Roland-Morris Disability Questionnaire, Trout et al. noted decreased pain and disability at one week after vertebroplasty, with maintenance of the pain relief at one year, in 113 patients who had a total of 164 vertebral fractures⁵⁶. McKiernan et al. thought that the Osteoporosis Quality of Life Questionnaire, with the responses marked on a visual analogue scale, was the best tool for evaluating health-related quality-of-life issues in osteoporotic women with back pain due to vertebral compression fractures⁵⁷. Their prospective evaluation of forty-six patients (sixty-six vertebral compression fractures) demonstrated marked improvement in all factors at one day after the vertebroplasty with persistence of, although a slight decrease in, the benefit at six months. Larger prospective cohort evaluations confirmed these outcomes, demonstrating decreases in pain and analgesic use and improvements in mobility^58,59. These studies did not show any clinically relevant complications. This suggests an improvement in the understanding and execution of this technique since earlier reports.

The limitations of the vertebroplasty technique are related to the inability of the procedure to correct spinal deformity and the risk of extravertebral polymethylmethacrylate extravasation during injection. During vertebroplasty, low-viscosity polymethylmethacrylate is injected under high pressure directly into cancellous bone. This makes it difficult to control polymethylmethacrylate flow into the vertebral body, creating the risk of extravasation outside of the vertebral body⁶⁰. Extravertebral extravasation of polymethylmethacrylate regularly occurs during vertebroplasty, with reported leak rates of up to 65%⁴². The rate of extravasation has been noted to be higher in patients with metastases or hemangiomas than in patients with osteoporosis^49,60.

Proponents of vertebroplasty have reported infrequent clinical sequelae of extravertebral leakage of polymethylmethacrylate. Cortet et al. reported extravertebral polymethylmethacrylate in association with thirteen of twenty vertebrae that had been treated with vertebroplasty because of an osteoporotic fracture⁴². Polymethylmethacrylate leaked into the paravertebral soft tissues in six cases, into the epidural space in three, into the disc space in three, and into the lumbar venous plexus in one. No adverse events were observed. Cyteval et al. noted extravertebral polymethylmethacrylate in eight of twenty patients treated with vertebroplasty, with leakage into the intervertebral disc in five patients, into the neural foramen in two, and into the lumbar venous plexus in one⁴³. Again, no adverse clinical events were observed. Chiras et al. reported that 4% of patients who had undergone vertebroplasty had radiculopathy that was likely related to intraforaminal polymethylmethacrylate leakage⁴¹. In a recent study, three of thirty-five patients treated with vertebroplasty had extravasation of polymethylmethacrylate into the epidural space, necessitating open surgical decompression in two of the patients⁶¹. Ryu et al. reported a 26.5% rate of epidural polymethylmethacrylate leakage following 347 vertebroplasties and concluded that the prevalence of epidural leakage depended on the amount of polymethylmethacrylate injected⁶². Use of a polymethylmethacrylate injector tool also increased the prevalence of epidural leakage, whereas the position of the needle tip in the vertebral body did not predict leakage. In summary, despite the substantial prevalence of extravertebral extravasation of polymethylmethacrylate during vertebroplasty, the risk of clinically relevant complications has been reported to be low.

It has been recommended that, to reduce extravertebral leakage of polymethylmethacrylate, studies with intravertebral injections of contrast medium be performed before injection of the polymethylmethacrylate in an attempt to predict potential egress of the polymethylmethacrylate from the vertebral body. Theoretically, extravasation of contrast medium signals the potential for subsequent extravasation of polymethylmethacrylate and thus indicates the need to redirect the needle and repeat the injection of the contrast material until no extravasation is observed. Lower volumes and higher viscosity of polymethylmethacrylate may also be warranted to avoid leakage. McGraw et al. found that intraosseous venography predicted the subsequent flow of polymethylmethacrylate during vertebroplasty in 83% of cases⁶³. Gaughen et al. reported that twenty-two of forty-two vertebrae demonstrated polymethylmethacrylate extravasation during vertebroplasty, and venograms had showed correlative extravasation in fourteen of the twenty-two cases⁶⁴. However, the authors concluded that venography did not improve the effectiveness or safety of vertebroplasty performed by experienced physicians. Using intravertebral injections of contrast medium, Phillips et al. showed that rates of transcortical and intravenous leakage of the contrast medium were higher for vertebroplasty than for kyphoplasty⁶⁵. Others have argued that intravertebral injections of contrast medium are not useful and that discontinuing the polymethylmethacrylate injection once the polymethylmethacrylate leaks out of the vertebral body or fills the perivertebral veins remains the best technique for reducing the risk of complications.

The pressurized injection of polymethylmethacrylate during vertebroplasty has also raised concerns about embolization of the polymethylmethacrylate, unreacted polymethyl methacrylate monomer, or bone marrow to the lungs through the venous system⁶⁶. Occasional cases of symptomatic and lethal polymethylmethacrylate pulmonary embolism following vertebroplasty have been reported^50,67-69.

Groen et al.⁷⁰ revisited the vertebral venous system, emphasizing its large volume; numerous valveless connections with cranial, spinal, thoracic, abdominal, and subcutaneous veins; and open connections to the vertebral body and its bone marrow. Because of these characteristics, there is a risk of extrusion of marrow and fat from the vertebral body during a forced external increase of intravertebral pressure. This risk of fat or marrow embolism is present during the polymethylmethacrylate injection in vertebroplasty and also during the balloon inflation in kyphoplasty. Also, polymethylmethacrylate extravasation through this venous system can be expected, particularly with the increased pressures and the more fluid polymethylmethacrylate mixture required during vertebroplasty⁷⁰. Complications including hypotension⁴⁹, pulmonary embolism^71,72, pulmonary polymethylmethacrylate embolism^50,68,73,74, adult respiratory distress syndrome⁴⁹, cerebral polymethylmethacrylate embolism⁷⁵, intravascular extension of polymethylmethacrylate⁷⁶, and polymethylmethacrylate toxicity⁷⁷ have been reported. An understanding of the pathomechanics, clinical indicators, and optimal technique for vertebroplasty is crucial, despite the low rate of these complications.

Kyphoplasty

Early results suggest that kyphoplasty can provide excellent pain relief, improve the height of the collapsed vertebral body, and reduce spinal kyphosis^{29,49,60,78-82}. Because kyphoplasty was first reported in 2000, the literature on this procedure is less extensive than that on vertebroplasty. Garfin and Reilly reported the initial multicenter experience with kyphoplasty, in which 2194 vertebral fractures in 1439 patients were treated between 1998 and 2000⁸³. Ninety percent of the patients reported pain relief within two weeks after the procedure. Four neurologic complications were reported in this series; all occurred in the first fifty patients treated, and all were directly attributable to surgeon error and breach of technique. Three cases of postoperative paraparesis were related to insertion of an instrument through the medial pedicle wall, and one epidural hematoma requiring surgical decompression was in a patient who was being treated with anticoagulants. The serious adverse event rate was 0.2% per fracture.

In the study by Wong et al., eighty of eighty-five patients reported good to excellent pain relief after kyphoplasty⁶⁰. As experience with kyphoplasty has increased, it has become apparent that the intravertebral cavity created by the inflatable bone tamp allows placement of more viscous, partially cured polymethylmethacrylate. In a prospectively followed cohort of patients treated with kyphoplasty, Lieberman et al. observed improvement in the postoperative scores for physical function, role limitations due to physical health, vitality, mental health, and social function on the Short Form-36 questionnaire⁸¹. Of seventy vertebral fractures that were treated, five were associated with a clinically irrelevant polymethylmethacrylate leak. The polymethylmethacrylate entered the epidural space in one case, the disc space in two cases, and the paraspinal tissues in three. No major systemic complications or neurologic injuries occurred. In a study of twenty-nine patients treated with kyphoplasty, Phillips et al. reported a decrease in the mean visual analogue pain score from 8.6 preoperatively to 2.6 at one week postoperatively to 0.6 at one year postoperatively³⁹. Polymethylmethacrylate leaks without apparent clinical consequence occurred at six of sixty-one vertebral levels, with no cases of leakage into the spinal canal.

In addition to pain relief, kyphoplasty affords the opportunity to restore vertebral body height and thereby improve spinal sagittal balance. In an ex vivo study, Belkoff et al. showed a 97% reversal of deformity with kyphoplasty and a 30% reversal with vertebroplasty⁷⁸. Lieberman et al. reported that height was increased (by a mean of 46.8%) in 70% of seventy fractured vertebrae treated with kyphoplasty⁸¹. Wong et al. similarly noted increased vertebral body height after kyphoplasty⁶⁰. Phillips et al. reported on a series of forty patients treated with kyphoplasty⁸⁴. In the patients who had reducible fractures, local kyphosis decreased by a mean of 14°. The ability to reduce kyphosis is thought to be a major benefit of kyphoplasty.

The complications of kyphoplasty mirror those discussed regarding vertebroplasty. There are concerns about embolic events initiated by the intravertebral pressure changes due to inflation of the bone tamp rather than the polymethylmethacrylate injection. Extravasation of polymethylmethacrylate also continues to be a concern, but the rate is lower given the low pressure and increased viscosity during the injection. Complications related to the hardware and balloon rupture have been reported^32,80. However, subsequent evaluations of larger groups treated with kyphoplasty support the earlier findings of successful management of both pain and deformity with low complication rates^85-87. Majd et al.⁸⁶ found an 89% rate of clinical success in 360 patients, and Ledlie and Renfro⁸⁷ reported radiographic evidence of success in 100 patients.

In an attempt to improve the reliability and extent of fracture reduction, one might consider performing kyphoplasty soon after the fracture. Our experience suggests that, in selected patients, it is easier to elevate the end plates and restore vertebral body height when the kyphoplasty is performed within one month after the fracture than when it is performed a number of months after the fracture. The appropriate duration of nonoperative treatment of a vertebral fracture before kyphoplasty is considered has not been established. It seems reasonable that patients presenting with an acute vertebral compression fracture and substantial kyphosis might be best managed with earlier intervention in an attempt to maximize improvement in spinal sagittal alignment. This may be particularly important at the thoracolumbar junction, where there is a tendency for the development of kyphosis. However, the efficacy of early intervention has not been elucidated.

Elderly patients with osteoporotic burst fractures and concomitant spinal stenosis can be extremely difficult to treat. Surgical decompression with instrumentation and fusion across the fractured segment is associated with a substantial risk of the instrumentation failing in the osteoporotic bone. Recently, Singh et al. reported the benefits of vertebral augmentation in conjunction with laminectomy to manage this clinical dilemma⁸⁸. Of twenty-five patients with lumbar spinal stenosis and osteoporotic vertebral fractures (thirty-nine fractures) in their series, nine required concomitant instrumentation for the treatment of spondylolisthesis at the decompressed level. Twenty of the twenty-five patients demonstrated a good or excellent result. Complications were observed in five patients. Others have reported similar successes with the management of burst fractures that presented without neurologic deterioration^33,89,90. The ability of kyphoplasty combined with posterior instrumentation to restore vertebral height and spinal alignment following thoracic and lumbar burst fractures was validated in a cadaver model⁹¹. Unfortunately, the rates of polymethylmethacrylate extravasation secondary to the disruption of the cortical osseous walls of the vertebrae may be a reason for concern, in particular because loss of the integrity of the posterior wall places the neural elements at risk. However, while the use of kyphoplasty for this injury profile is not without risks, the potential to relieve symptoms and provide structural improvement is promising. Presently, there is insufficient information to fully understand the role of polymethylmethacrylate augmentation in the treatment of osteoporotic vertebral burst fractures.

Subsequent Vertebral Fracture After Vertebroplasty and Kyphoplasty

It remains unclear whether subsequent vertebral fractures are related to the natural progression of osteoporosis or are a consequence of augmentation with bone polymethylmethacrylate⁹². A natural history study of 2725 women with a mean age of seventy-four years demonstrated a cumulative incidence of new vertebral fractures of 6.6% in the first year²⁶. The incidence of second vertebral fractures in the first year after an initial vertebral fracture was 19%. Only 23% of these second fractures were symptomatic; thus, 5% of women with an untreated compression fracture are expected to sustain a symptomatic subsequent vertebral fracture within one year.

The rate of vertebral fracture following vertebroplasty has been reported to be between 12% and 52%, depending on the duration and nature of the follow-up^55,93. Two-thirds of these fractures were identified at levels adjacent to the vertebroplasty and the remainder, at remote levels⁹³. Grados et al. reported that the odds ratio of a vertebral fracture occurring in the vicinity of a polymethylmethacrylate-augmented vertebra was 2.27 compared with an odds ratio of 1.44 for a vertebral fracture occurring in the vicinity of an uncemented fractured vertebra⁵⁵. This equates to a 57% greater risk of fracture adjacent to a vertebroplasty.

The rate of vertebral fracture following kyphoplasty is 19% to 29%, again depending on the duration and nature of the follow-up. Fribourg et al. documented a subsequent fracture rate of 26%, with 63% of the fractures occurring at adjacent levels⁹⁴. These adjacent-level fractures occurred within sixty days after the kyphoplasty. Thereafter, the fracture incidence mirrored that found in the natural history study described above²⁶, and adjacent-level fractures no longer predominated. Fribourg et al. suggested that patients should be informed of this fracture risk in the early postoperative period.

Harrop et al. found a subsequent vertebral fracture in 23% of 115 patients treated with kyphoplasty⁹⁵. While no correlation was found between recurrent fractures and age, bone density, T score, gender, or number of augmented levels, stratification by osteoporosis type (primary versus steroid-induced) delineated patients at increased risk. A subsequent fracture was observed in 49% of patients with steroid-induced osteoporosis compared with only 11% of those with primary osteoporosis. Steroid-induced osteoporosis, rather than the kyphoplasty, was thought to be a greater risk factor predicting subsequent fractures. In the only prospective controlled study of kyphoplasty of which we are aware, Kasperk et al. confirmed the nonsignificant differences in the rate of subsequent fractures, at both six and twelve months, between patients treated with kyphoplasty and those managed medically^96,97. The correction of biomechanical variables following kyphoplasty should work to counteract subsequent fractures¹². Thus, the concern regarding subsequent vertebral fracture following polymethylmethacrylate augmentation persists but is unconfirmed.

Advantages

Vertebroplasty: The advantages of this technique are its simplicity and its ability to relieve pain. The procedure is typically performed with the use of local anesthesia and intravenous sedation. The avoidance of general anesthesia for frail, elderly patients is advantageous. The procedure is straightforward to perform and requires little special equipment. This can equate to faster procedure times and lower costs.

Kyphoplasty: The advantages of this technique are deformity correction and relief of pain. Fracture reduction and correction of kyphotic deformity can be achieved with use of specialized instrumentation. It has been hypothesized that restoration of spinal alignment improves the functional capacity of the respiratory, cardiac, gastrointestinal, and musculoskeletal systems. Decreased polymethylmethacrylate extravasation resulting from low-pressure injection of more viscous polymethylmethacrylate reduces complications. Kyphoplasty is more costly than vertebroplasty.

Operative Technique

Before proceeding with either intervention, the physician must confirm that the back pain is caused by a vertebral compression fracture. This requires careful correlation of the patient's history and findings on clinical examination with radiographic documentation of an acute or unhealed vertebral compression fracture. The possibility of secondary osteoporosis or a malignant tumor producing the back pain must be considered. Degenerative spinal disorders may also present with kyphosis and back pain. A thorough neurologic examination is essential to rule out neurologic compromise. Pain radiating around the trunk in a dermatomal manner may accompany vertebral compression fractures. Pulmonary function should be evaluated in patients in whom advanced kyphosis may have led to respiratory difficulty.

Preoperative planning includes making radiographs to define the fracture geometry and for surgical planning. Lateral radiographs are particularly useful for planning the trajectory for any percutaneous procedure. Magnetic resonance imaging is typically used to evaluate the acuity of the fracture. When magnetic resonance imaging is contraindicated, nuclear bone scans may help the physician to estimate the acuity of the fracture. Osseous edema is readily visualized on magnetic resonance imaging and can indicate an acute fracture as well as help rule out a tumor or infection. Malignant diseases causing vertebral compression fracture are usually associated with an ill-defined margin, enhancement with gadolinium, and pedicle involvement as well as a paravertebral soft-tissue mass⁹⁸. Sagittal magnetic resonance images with short tau inversion recovery (STIR) sequences highlight the marrow edema changes associated with acute fractures, and STIR magnetic resonance imaging has proved to be useful in determining the acuity of a vertebral compression fracture.

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Figs. 1-A and 1-B: Transpedicular approach for vertebral augmentation. The tip of the injection trocar is started at the lateral aspect of the facet joint corresponding with the upper and outer corner of the pedicle outline as visualized on the posteroanterior image (Fig. 1-A). The proper sagittal trajectory is confirmed on the lateral image. When the trocar tip is midway along the length of the pedicle on the lateral image, it should be central in the pedicle outline on the posteroanterior image (Fig. 1-B). When the trocar is through the pedicle and at the posterior vertebral cortical margin on the lateral image, it should be just within the medial border of the pedicle outline on the posteroanterior image.

To perform either of the operations, the patient is positioned prone on the operating room table or in the radiology suite on a spinal frame with cushioned bolsters. Attention to patient positioning and bolster support on the procedure table can provide postural fracture reduction, thus improving the chance of correcting kyphosis. Local anesthesia with intravenous conscious sedation (more common for vertebroplasty) or general anesthesia (more common for kyphoplasty) may be used. Local anesthesia may be preferable for patients with medical illness. Fluoroscopy is used throughout the procedure, and we prefer simultaneous biplanar fluoroscopy.

Typically, the transpedicular approach is used in the lumbar spine. The tip of the injection trocar is started at the outer aspect of the pedicle as visualized on the posteroanterior image, and the proper sagittal trajectory is confirmed on the lateral image (Figs. 1-A and 1-B). When the trocar tip is midway along the length of the pedicle on the lateral image, it should be central in the pedicle outline on the posteroanterior image. When the trocar is through the pedicle and at the posterior vertebral cortical margin on the lateral image, it should be just within the medial border of the pedicle outline on the posteroanterior image. For vertebroplasty, the trocar is advanced until the tip is at the junction of the anterior and middle thirds of the vertebral body. For kyphoplasty, the positioning trocar is exchanged for a working cannula over a guidewire. The cannula is positioned near the posterior margin of the vertebral body while the working instruments are advanced anteriorly until they are 3 mm from the anterior border of the vertebral body³².

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Fig. 2: Extrapedicular approach for vertebral augmentation. The starting point is craniolateral toward the costovertebral joint. Contact is made with the neck of the rib or transverse process. The needle is advanced along the neck of the rib, passed under the transverse process, and passed through the ligament complex of the costovertebral joint until the lateral pedicle wall is reached. The needle is then advanced into the vertebral body.

The extrapedicular approach is commonly used in the thoracic spine because of the smaller pedicle diameter and a less medially angulated pedicle trajectory. The starting point is craniolateral toward the costovertebral joint (Fig. 2). Contact is made with the neck of the rib or transverse process. The needle is advanced along the neck of the rib, passed under the transverse process, and passed through the ligament complex of the costovertebral joint until the lateral pedicle wall is reached. The projection of the tip of the needle should be at the upper and outer circumference of the pedicle as seen on the posteroanterior image. On the lateral image, the tip of the needle should be projected between the pedicle margins and anterior to the facet joints. Only after the posterior vertebral wall has been passed on the lateral image should the tip of the needle cross the medial pedicle wall on the posteroanterior image. Strict adherence to these landmarks is mandatory to avoid spinal perforation^32,99. Boszczyk et al. utilized this technique to perform kyphoplasty at levels from T2 to T8 and noted precise introduction of the tools in all fifty-five vertebrae, despite the narrow pedicle diameter⁹⁹.

A unipedicular rather than a bipedicular technique has been suggested to decrease risks associated with cannulation, operative time, radiation exposure, and cost. The unipedicular technique for both vertebroplasty and kyphoplasty has been shown to restore strength, stiffness, and height as well as the bipedicular technique in a cadaver model^100,101. Lateral wedging was not observed. Using a finite-element model, Liebschner et al. found that, although unipedicular polymethylmethacrylate injection restored stiffness, a medial-lateral bending motion (toggle) toward the untreated side with application of a uniform compressive load was created¹⁰². This finding has not been confirmed in clinical trials.

Performance of a vertebral body bone biopsy should be considered. When a trephine needle was used prior to polymethylmethacrylate injection, adequate tissue was obtained for analysis from 67% to 100% of the samples^36,99. Togawa et al. obtained biopsy specimens from 178 vertebrae and identified possible osteomalacia in 21% of them, with another four confirming an occult or unconfirmed plasma cell dyscrasia¹⁰³. Togawa et al. advocated performance of a biopsy during each first-time vertebral augmentation procedure so as not to miss occult lesions.

Vertebroplasty: After proper needle placement and biopsy, polymethylmethacrylate is injected through a cannula into the vertebral body. The polymethylmethacrylate should be of a consistency that minimizes filling pressures and yet prevents leakage. The judicious use of fluoroscopic imaging throughout the procedure is paramount to the success and safety of a vertebroplasty. The procedure is completed when imaging demonstrates adequate vertebral filling or when extravasation of the polymethylmethacrylate is identified.

Kyphoplasty: After proper needle placement and biopsy, the inflatable balloon tamp (KyphX Inflatable Bone Tamp; Kyphon, Sunnyvale, California) is inserted through the cannula and expanded under visual (fluoroscopic) and volume and pressure (digital manometer) controls. The bone tamp is inflated until fracture reduction is achieved, the maximal pressure or volume of the balloon is reached, or contact occurs with the cortical wall. The balloon is then deflated and removed. Partially cured polymethylmethacrylate can then be introduced through the cannula under low pressure to fill the void created by the balloon tamp. The volume of the polymethylmethacrylate should approximate that of the intravertebral cavity. Volumes from 3.5 to 8.5 mL have been observed³⁶. Again, the judicious use of fluoroscopic imaging throughout the procedure is paramount. To our knowledge, no one has quantified polymethylmethacrylate viscosity to define an optimal injection.

Biomaterials

To date, the majority of vertebroplasty and kyphoplasty procedures have been performed with use of polymethylmethacrylate to augment the fractured vertebral body. The mechanism of pain relief by these procedures is uncertain and may be related to polymethylmethacrylate "stabilization" of the fractured vertebral body or deafferentation related to heating of nerve endings as the polymethylmethacrylate cures. The optimal polymethylmethacrylate volume required to relieve pain and restore strength and stiffness is unknown. In an ex vivo study of experimental osteoporotic compression fractures, injection of 2 mL of polymethylmethacrylate (with barium sulfate) restored vertebral strength (the ability of the vertebral body to bear load) to prefracture levels, whereas 4 to 8 mL of polymethylmethacrylate was required to restore stiffness (resistance to micromotion)¹⁰⁴.

For many years, polymethylmethacrylate has been widely used around joint prostheses, to fill long-bone defects, and to reconstruct the spinal column^105-107. Potential problems with polymethylmethacrylate include the exothermic reaction during the curing process, when temperatures may reach 100°C and cause thermal damage to adjacent structures; cardiopulmonary toxicity of the unreacted monomer; and the lack of long-term biointegration of the polymethylmethacrylate. A repair process, including primitive mesenchymal cell proliferation, neovascularization, resorption of dead bone, and new bone formation, was found to be absent in a histopathological assessment following polymethylmethacrylate augmentation of vertebral fractures¹⁰⁸.

The ideal biomaterial for vertebral augmentation would be radiolucent and nontoxic, would have handling characteristics that allow easy injection, would undergo a gradual transition from a viscous to a solid state with low exothermic temperatures, and would have adequate compressive strength to stabilize the fractured vertebral body. An osteoconductive, biodegradable material, which is replaced by host bone, may be advantageous; however, the ability of osteoporotic bone to remodel and replace a biodegradable material with host bone of adequate quality is uncertain and must be studied before such materials are considered for clinical use. A number of alternate biomaterials, including carbonated apatite¹⁰⁹, bioactive polymethylmethacrylate¹¹⁰, and calcium phosphate^111,112, have been shown to substantially improve compressive strength and load to failure of vertebral bodies. A more extensive understanding of the toxicity profiles and long-term stability of these materials is essential.

Radiation

As the number of minimally invasive techniques to treat spine disorders, and the number of vertebroplasties and kyphoplasty procedures in particular, increases, the use of radiographic guidance in the operating room increases as well. Concerns regarding the radiation exposure to both the patient and the surgeon have been raised.

Boszczyk et al. monitored the radiation exposure to the patients during sixty kyphoplasty procedures guided with biplanar fluoroscopy to treat 104 vertebrae¹¹³. Exposure times per level during lateral plane imaging were noted to be 2.2 minutes for a single level and 1.7 minutes for a multiple-level session. Exposure times per level during anteroposterior plane imaging were noted to be 1.6 minutes for a single level and 1.1 minutes for a multiple-level session. Imaging times in the lateral plane consistently remained above those in the anteroposterior plane. Entrance skin doses ranged from 0.05 to 1.43 Gy with average values of 0.68 Gy in the lateral plane and 0.32 Gy in the anteroposterior plane. Calculated effective dose values averaged 4.28 mSv with a maximum of 10.14 mSv. In light of a baseline risk of cancer death of 20% to 25%, the postulated increase in lifetime cancer risk after a single kyphoplasty procedure was 0.02% to 0.06%.

Harstall et al. monitored the radiation exposure to the surgeon during thirty-two vertebroplasty procedures performed with use of a single fluoroscopic unit to image in two planes to treat 136 vertebrae¹¹⁴. The average operative time was 56.2 minutes, and an average of 4.25 vertebrae were augmented. The average exposure time was 2.23 minutes per augmented vertebra. Measurements at the thyroid gland, eye lens equivalent, left and right hands, left arm, and back demonstrated radiation doses per augmented level of 0.052, 0.020, 0.107, 0.049, 0.084, and 0.002 mSv, respectively. Extrapolated radiation doses per year were troubling. Eight percent of the maximum allowed annual dose for the eye lens is expected with this procedure alone. While the annual morbidity risk for thyroid exposure was calculated to be 0.025%, representing a low to medium one-year risk, the lifetime risk was considered to be high to very high.

Average whole-body doses are variable and have been calculated to be between 1.44 mSv per level and 96 mSv per patient^115,116. Theocharopoulos et al. concluded that 90% of the surgeon's effective radiation dose and cancer risk was attributed to kyphoplasty and vertebroplasty procedures, with another 8% attributed to other spine procedures, at their center¹¹⁶.

Certain intraoperative techniques reduce radiation exposure time. Biplanar fluoroscopy eliminates the unnecessary exposure time required for repositioning of equipment. Surgeon-controlled foot pedals to direct fluoroscopy time streamlined operative flow. In one study, whenever feasible with regard to fluoroscopic visualization, the polymethylmethacrylate was injected into as many as three adjacent vertebrae simultaneously¹¹³. Pulsed fluoroscopic operation at 4 pulses/sec, positioning of the radiograph tube under the patient table, and use of lead sheets on the patient and a lead apron, lead collar, and goggles by the surgeon further minimize radiation exposure^114,115. If these measures are followed, exposure levels will be sufficiently low to permit the safe performance of more than 6700 vertebroplasty procedures by a single surgeon per year¹¹⁵.

Overview

Minimally invasive operative techniques are being used with increasing frequency to manage vertebral compression fractures. Alleviation of fracture pain and optimization of comorbid factors aggravated by these fractures have been demonstrated after use of these techniques. Both vertebroplasty and kyphoplasty demonstrate distinct advantages. Complications do occur during both procedures, but they can be minimized through meticulous surgical technique and surgeon experience. Greater understanding of the histopathological, biomechanical, and clinical factors involved in these techniques will provide even greater successes in the future.

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Topics

osteoporosis ; fracture ; pain ; polymethyl methacrylate ; spinal fractures ; vertebroplasty ; kyphoplasty ; vertebrae ; spinal compression fractures ; vertebral body

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Neil A. Manson, Frank M. Phillips; Minimally Invasive Techniques for the Treatment of Osteoporotic Vertebral Fractures. The Journal of Bone & Joint Surgery. 2006 Aug;88(8):1862-1872.

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