October 4, 2010 — The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved and issued a clinical practice guideline for treatment of symptomatic osteoporotic spinal compression. The new practice parameters, which are published in the September 27 issue of AAOS Now, include a strong recommendation against vertebroplasty for treatment of spinal compression fractures.

"It's very important to understand that we went into this without any preconceived notions or preferences, and we all agreed that the practice of medicine has to be based on science, and not anecdotal information," said guidelines work group chair Stephen I. Esses, MD, from the Southwest Orthopedic Group in Houston, Texas, in a news release. "When you look at the science and research to-date, there is very strong Level 1 evidence to suggest that vertebroplasty does not provide the types of benefits that it was previously thought to provide."

A volunteer, physician work group developed the evidence-based, patient safety best clinical practice guideline for several years, shaped by a methodic literature search and systematic review of the current scientific and clinical information and accepted strategies for treatment and/or diagnosis.

Data review began in early 2008 by a review panel consisting of internal and external committees, public commentaries, and final approval by the AAOS Board of Directors. The work group developed the clinical recommendations using systematic, evidence-based processes intended to counteract bias, improve transparency, and promote reproducibility.

In the United States, annual incidence of new vertebral fractures is approximately 750,000, with estimated healthcare costs of $17 billion in 2005. In addition to surgery, other available treatments considered by the work group included pharmacotherapy and nerve blocks directed at relieving pain caused by spinal fractures.

Vertebroplasty, typically performed in women older than 65 years with evidence of osteoporosis and pain resulting from spinal vertebral compression fractures, involves injecting bone cement into the vertebra to stabilize fractures.

In 2 randomized controlled clinical trials comparing vertebroplasty vs a sham procedure, there was no statistically significant difference between the 2 procedures in pain relief. Although criticisms of these trials have been published, the work group concluded that evidence to date does not support these criticisms.

"Previous studies have touted the benefits of vertebroplasty, however our scientific research suggests this surgical procedure does not offer any advantages, over the placebo control," Dr. Esses said. "But there is not a worry that something is going to happen to you if you had this surgery already. There are no reported negative eventual side effects."

Specific Recommendations

Specific recommendations in the clinical practice guideline for treatment of symptomatic osteoporotic spinal compression include the following:

• Neurologically intact patients presenting with imaging evidence of an osteoporotic spinal compression fracture as well as consistent clinical signs and symptoms suggesting an acute injury (0 - 5 days after identifiable event or onset of symptoms) should be treated with calcitonin for 4 weeks (strength of recommendation: moderate).
• For patients who present with imaging evidence of an osteoporotic spinal compression fracture and corroborating clinical signs and symptoms, options to prevent additional symptomatic fractures are ibandronate and strontium ranelate (strength of recommendation: weak).
• For neurologically intact patients presenting with osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms, the work group could not recommend for or against bed rest, complementary and alternative medicine, or opioids/analgesics (strength of recommendation: inconclusive).
• An L2 nerve root block is a treatment option for neurologically intact patients who present with an osteoporotic spinal compression fracture at L3 or L4 on imaging with correlating clinical signs and symptoms suggesting an acute injury (strength of recommendation: weak).
• For neurologically intact patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms, the work group was unable to recommend for or against treatment with a brace (strength of recommendation: inconclusive).
• The work group could not recommend for or against a supervised or unsupervised exercise program for neurologically intact patients presenting with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms (strength of recommendation: inconclusive).
• The work group could not recommend for or against electrical stimulation for neurologically intact patients with an osteoporotic spinal compression fracture on imaging as well as corroborating clinical signs and symptoms (strength of recommendation: inconclusive).
• The clinical practice guideline recommends against vertebroplasty for neurologically intact patients who present with imaging evidence of an osteoporotic spinal compression fracture and who have correlating clinical signs and symptoms (strength of recommendation: strong).
• However, kyphoplasty is an option for neurologically intact patients presenting with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms (strength of recommendation: weak).
• The work group could not recommend for or against improvement of kyphosis angle when treating patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms (strength of recommendation: inconclusive).
• For patients who are not neurologically intact and who present with an osteoporotic spinal compression fracture on imaging with corroborating clinical signs and symptoms, the work group was unable to recommend for or against any specific treatment (strength of recommendation: inconclusive).

"This summary of recommendations is not intended to stand alone," the guidelines authors write. "Treatment decisions should be made in light of all circumstances presented by the patient. Treatments and procedures applicable to the individual patient rely on mutual communication between patient, physician, and other healthcare practitioners."

Dr. Esses has disclosed affiliations with Orthopedics, Spine and the SpineJournal. All work group members' disclosures are posted at the AAOS Web site .

AAOS Now. September 27, 2010.

Clinical Context

Clinical Implications

• In neurologically intact adults with osteoporotic spinal compression fracture, vertebroplasty does not significantly reduce pain or improve function and is therefore not recommended.
• In neurologically intact adults with osteoporotic spinal compression fractures, options to reduce pain include calcitonin, nerve root block, and kyphoplasty.

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