By Robert A. McGuire Jr, MD
New guideline recommends against use of vertebroplasty
At their meeting on Sept. 24, 2010, the AAOS Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures (Fig. 1). The new guideline includes 11 recommendations, including one that is strongly supported by good quality evidence and one that is supported by fair quality evidence (see Table 1, PDF). In most areas, however, evidence was insufficient or conflicting and did not enable the work group to make a recommendation for or against the intervention.
Fig. 1 Standing lateral radiograph showing a wedge compression fracture of L3. (Reprinted from Faciszewski T, McKiernan FE, Rao R: Management of osteoporostic vertebral compression fractures, in Spivak JM, Connolly PJ (eds). Orthopaedic Knowledge Update Spine 3, Rosemont, Ill., American Academy of Orthopaedic Surgeons/North American Spine Society, 2006, pp. 377-386)
Osteoporotic spinal compression fractures can have a devastating impact on patients. Vertebral fractures can lead to back pain, loss of height, deformity, immobility, increased number of bed days, and even reduced pulmonary function. Their impact on quality of life can also be profound, resulting in a loss of self-esteem and development of a distorted body image and depression. Vertebral fractures also significantly impact on activities of daily living.
Each year in the United States, patients sustain an estimated 750,000 vertebral compression fractures due to osteoporosis. Approximately one in four adults older than age 50 will have at least one vertebral fracture in their lifetime. In 2005, an estimated $17 billion was spent in treating osteoporotic compression fractures; this figure is expected to increase significantly as our aging population swells.
Treatment of these fractures has focused on relieving pain and restoring mobility and function. Although most fractures heal within a few months, some people have continuing pain and disability.
Both surgical and nonsurgical treatments are available. Surgical treatments may include minimally invasive procedures such as vertebroplasty (an injection of cement directly into the vertebral body and kyphoplasty (use of balloon to expand the compressed space prior to the injection of bone filler). Nonsurgical treatments include the use of pain relievers, braces, electrical stimulation, and exercise. Additionally, complementary or alternative medical treatments such as acupuncture, massage, or the use of dietary supplements have been applied.
The importance of evidence
The quality of the evidence is critical in the development of clinical practice guidelines. The higher the quality of evidence, the more confidence one has in the guideline. The work group considered only the best available evidence in the development of this guideline and recommendations.
High-quality evidence was not available to support many of the treatments currently being used for patients with osteoporotic spinal compression fractures. As a result, the work group was unable to support or oppose such common treatments as bed rest, complementary or alternative medicine, exercise, the use of analgesics or opioids, bracing, or electrical stimulation.
The guidelines do, however, include one recommendation supported by moderately high-quality evidence and one strong recommendation supported by evidence that the work group found both overwhelming and compelling.
The first recommendation—a suggestion that patients who have radiographic evidence of an osteoporotic spinal compression fracture with correlating clinical signs and symptoms suggesting an acute injury (within 5 days of an identifiable event or onset of symptoms) and who are neurologically intact be treated with calcitonin for 4 weeks—is based on two Level II studies that showed administration resulted in clinically important reductions in pain. Two other Level II studies had similar results, but were not as well-defined.
Although the work group found numerous studies examining the effects of medical and conservative treatments for osteoporotic spinal compression fractures, few met the established criteria for consideration. For example, the use of ibandronate and strontium ralinate as an option to prevent additional symptomatic fractures in those patients with previous spinal compression fractures is a weak recommendation, in part because studies using this therapy did not report the critical outcome sought by the work group.
Fig. 2 The guidelines consider the option of kyphoplasty for treatment of vertebral insufficiency fractures to be a weak recommendation considering present scientific publications.
Vertebroplasty and kyphoplasty
The recommendations also consider two surgical procedures often used to treat vertebral compression fractures: vertebroplasty and kyphoplasty.
The single strong recommendation in the guidelines is based on two Level I studies comparing vertebroplasty to a sham procedure, and three Level II studies comparing vertebroplasty to conservative treatment:
We recommend against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.
By making a strong recommendation against the use of vertebroplasty, the group is expressing its confidence that future evidence is unlikely to overturn the results of these trials.
The guidelines consider kyphoplasty to be an option (weak recommendation). Although the two Level II studies that compared kyphoplasty to conservative treatment did find clinically important pain relief at various points, both were flawed. The three studies comparing kyphoplasty to vertebroplasty had inconsistent results.
Although kyphoplasty and vertebroplasty are similar procedures, the evidence supports treating them differently within the recommendations. In a comparison of kyphoplasty to conservative treatment, for example, possibly clinically important differences for critical outcomes were seen for up to 12 months; comparing vertebroplasty to conservative treatment showed possibly clinically important differences for these outcomes only on the first day after surgery.
Additionally, a direct comparison between the two procedures showed a possibly clinically important advantage in critical outcomes for kyphoplasty at up to 2 years. The fact that these results were not consistent among all studies, however, lowered the confidence level that future research will confirm the results of current evidence and resulted in the “weak” recommendation.
Several points were “inconclusive” because the work group found no studies that met our inclusion criteria. We hope this will be an incentive for researchers to develop and conduct quality studies in these areas.
Disclosure information: Dr. McGuire—DePuy, Synthes, AOSpine, Journal of Spinal Disorders; Ms. Porucznik—no conflicts.
Robert A. McGuire, MD, served as vice-chair of the work group. He can be reached at firstname.lastname@example.org
How the guidelines came to be
The Clinical Practice Guideline on the Treatment of Symptomatic Osteoporotic Compression Fractures, adopted by the AAOS Board of Directors at their September 2010 meeting, was developed by a multidisciplinary volunteer work group that included orthopaedic surgeons who practice in a variety of settings, along with assistance from the AAOS guidelines unit. They included Stephen I. Esses, MD, chair; Robert A. McGuire Jr, MD, vice-chair; John Jenkins, MD; Joel Finkelstein, MD; Eric Woodard, MD; William C. Watters III, MD; Michael Keith, MD; Michael J. Goldberg, MD; Charles M. Turkelson, PhD; Janet L. Wies, MPH; Patrick Sluka, MPH; Kevin Boyer, Kristin Hitchcock, MSI, and Sara Anderson, MPH.
Among the groups that participated in peer review of this guideline were the American Academy of Physical Medicine and Rehabilitation; American Association of Neurological Surgeons; American College of Radiology; American College of Surgeons; American Osteopathic Association; International Spine Intervention Society; National Osteoporosis Foundation; North American Spine Society. Participation in the peer review process does not constitute an endorsement of these guidelines by the participating organization.
Funding was provided solely by the AAOS.
The guideline is based on a systematic review of the current scientific and clinical information on accepted approaches to treatment. The entire process included a review panel of internal and external committees, public commentaries, and final approval by the AAOS Board of Directors on Sept. 24, 2010.
The methods used to prepare this guideline were rigorous, employed to minimize bias and to develop a set of reliable, transparent, and accurate clinical recommendations for treating symptomatic osteoporotic spinal compression fractures. These methods are detailed in the full guideline.
The development of AAOS evidence-based clinical practice guidelines is overseen by the Guidelines and Technology Oversight Committee and the Evidence-Based Practice Committee. The guideline is available at www.aaos.org/guidelines
October 2010 Issue
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