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
Symptomatic osteoporotic spinal compression fractures are common, with 750,000 new vertebral fractures occurring annually in the United States, according to Buchbinder and colleagues in the August 6, 2009, issue of the New England Journal of Medicine. The goal of treatment is to relieve pain and improve mobility.
The AAOS conducted a systematic review to provide practice recommendations in the treatment of neurologically intact adults with symptomatic osteoporotic spinal compression fractures on imaging with correlating clinical signs and symptoms.
Study Highlights
- The AAOS work group conducted a systematic review between March 2009 and February 2010 and met to develop the recommendations.
- The guidelines were approved by the AAOS Evidence Based Practice Committee; Guidelines and Technology Oversight Committee; Council on Research, Quality Assessment, and Technology; and the AAOS Board of Directors.
- Inclusion criteria were full-article report of a clinical study that was published in the English language, published in or after 1966, appeared in a peer review publication, included at least 10 subjects, presented quantitative results, enrolled subjects at least 18 years old, and provided at least 50% patient follow-up.
- Exclusion criteria were in vitro, biomechanical, or cadaver studies, studies of patients with osteogenesis imperfecta or solid metastatic tumor of the spine, and post hoc subgroup analysis.
- 50 of 6521 identified citations met inclusion criteria.
- In adults with symptomatic vertebral fractures up to 5 days after an event or onset of symptoms, treatment with calcitonin for 4 weeks is suggested, based on 4 studies with 218 patients:
- 200 IU of calcitonin intranasally or suppositories reduced pain at 4 weeks and 3 months.
- Treatment options to prevent additional symptomatic vertebral fractures are ibandronate and strontium ranelate, based on 37 studies with 18,305 patients:
- 3 studies enrolled symptomatic patients.
- 34 studies enrolled patients with symptomatic or asymptomatic fractures.
- Daily or intermittent ibandronate reduced new symptomatic fractures at 3 years.
- Daily strontium ranelate reduced new symptomatic fractures at 1 and 3 years.
- Strontium ranelate is not approved for marketing in the United States.
- Daily pamidronate did not reduce new symptomatic fractures.
- There were inadequate data to address the use of bed rest, complementary and alternative medicine, or opioids or analgesics.
- In patients with fracture at L3 or L4, a treatment option is an L2 nerve root block, based on 1 study of 60 patients:
- Nerve root block reduced pain for no more than 2 weeks and did not affect function.
- The evidence for brace use was inconclusive, based on 1 study of 62 patients that showed reduced pain, improved function, and improved well-being at 6 months, with statistical, but uncertain clinical, significance.
- The evidence for a supervised or an unsupervised exercise program was inconclusive, based on 1 study of 60 patients that did not document whether the measured back pain was related to the fracture:
- Exercise improved symptom measures at 6 and 12 months, emotion and leisure/social measures at 6 months, and activities of daily living at 12 months.
- The evidence for electrical stimulation was inconclusive, based on 1 study on 41 patients that lacked sufficient power to detect differences in pain or quality of life.
- Vertebroplasty is not recommended:
- 2 studies with 209 patients found no significant differences in pain, function, or quality of life at up to 6 months for vertebroplasty vs placebo.
- 3 studies with 210 patients found significantly reduced pain at 24 hours, improved function at 2 and 6 weeks, and improved quality of life and reduced analgesic use at 2 weeks for vertebroplasty vs conservative treatment, but no subsequent improvement.
- Fracture-related, but not overall, mortality rate, was reduced with vertebroplasty vs conservative treatment.
- Kyphoplasty is an option to reduce pain and improve function:
- 2 studies with 360 patients found that kyphoplasty vs conservative treatment reduced pain and improved quality of life for 12 months; the procedure also improved function for 6 months.
- Of 3 studies with 172 patients, only 1 found that kyphoplasty vs vertebroplasty reduced pain for up to 2 years.
- There were inadequate data on the correction of kyphosis angle and clinical outcomes.
- For patients who are not neurologically intact, no studies were identified.
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.
