AAOS Clinical Guideline for Treating Spinal Compression Fractures Presents More Questions Than Answers for Medical Community

WASHINGTON, Nov. 9, 2010 /PRNewswire/ -- The clinical practice guideline recently issued by the American Academy of Orthopaedic Surgeons (AAOS) for treating spinal compression fractures has left the medical community scratching its head about what to tell patients.

Spinal compression fractures (also called vertebral compression fractures or VCFs) are the most common complication of osteoporosis, a disease that affects an estimated 44 million Americans, or 55 percent of adults age 50 and older.(1) Approximately 700,000 new VCFs occur annually. (2,3) They cause intractable pain and are a source of increased morbidity.(5,6)

Of the 11 recommendations made by AAOS, more than half are rated as “inconclusive.” According to the group, evidence quality was critical in supporting the practice guidelines and it didn’t find enough high-quality evidence to support or oppose most non-surgical treatments, including traditional treatment options such as bed rest, analgesics, bracing, and physical therapy.(4)

AAOS made only one “strong” recommendation. It was against the use of vertebroplasty, a minimally invasive procedure that involves injecting bone cement into the fracture to stabilize, strengthen the vertebra and provide pain relief. The group based its recommendation on the results of two studies published in the New England Journal of Medicine (NEJM). The studies compared vertebroplasty against a sham procedure and found no statistically significant difference between the two.(7,8)

But did the studies exhibit enough clinical efficiency to justify that recommendation? “No,” says Dr. Wayne Olan, MD, Director of Interventional and Endovascular Neurosurgery at George Washington University Medical Faculty Associates in Washington, DC, and a consulting physician for neuroradiology at the National Institutes of Health in Bethesda, Md. “The NEJM studies don’t come close to the standards AAOS set for its guideline. Their methodology is flawed and their conclusions are at odds with more than 20 years of research studies that substantiate the efficacy of vertebroplasty.”

Numerous commentaries from medical experts agree with Dr. Olan. They criticize Kallmes et al and Buchbinder et al for including patients with sub-acute and chronic fractures up to a year old, inconsistent use of the evidence of bone marrow edema on MRI as an inclusion criteria, selection bias, statistical power of the sample size, the absence of a control group that did not get an intervention, and the high crossover from placebo to vertebroplasty.

A more rigorous study, says Dr. Olan, is “Vertebroplasty vs. Conservative Treatment in Osteoporotic Vertebral Compression Fractures” (VERTOS II), published recently in The Lancet.(3)

VERTOS II is the largest, peer-reviewed study of vertebroplasty to date. In it, 202 patients with acute fractures confirmed by edema on MRI were randomly allocated to receive either vertebroplasty or conservative medical therapy. Patients receiving vertebroplasty had greater pain relief – as measured on a visual analog scale (VAS) – from the first day after the procedure to one year later than those treated conventionally. From baseline, the reductions in pain were 5.2 at 1 month and 5.7 at 1 year. Pain reductions in the control group were less substantial at 2.7 at 1 month and 3.7 at 1 year.(3)

“Randomized, sham or placebo-controlled trials provide only an approximation of the truth. Information from observational outcome studies is also important because patients and physicians in the real world don’t always behave like those in clinical trials,” says Dr. Olan.

“As physicians we need to weigh study results against our own experience. VERTOS II and the countless patients I’ve treated who have benefitted from vertebroplasty validate this procedure’s efficacy.”

In addition to his practice, Dr. Olan is an associate professor of Neurosurgery and Radiology at The George Washington University Medical Center in Washington, DC. He has participated in multiple clinical trials and published extensively on minimally invasive spinal interventions. He is also a frequent lecturer and instructor around the world regarding minimally invasive spinal techniques and co-authored the ACR standards for vertebroplasty.

Disclosures:

Dr. Olan is a consultant with Stryker Interventional Spine and conducts minimally invasive spine workshops supported by the company.

References:

1 National Osteoporosis Foundation. Available at http://www.nof.org/node/40 Accessed Nov. 2, 2010

2 The Orthopaedic Industry Annual Report: 2008-2009 ORTHOWORLD.

3 Klazen C, Lohle P, et al “Vertebroplasty Versus Conservative Treatment in Acute Osteoporotic Vertebral Compression Fractures (VERTOS II): An Open-Label Randomized Trial” Lancet 2010; DOI: 10.1016/S0140-6736 (10)60954-3

4 The Treatment of Symptomatic Osteoporotic Spinal Compression Fractures: Guideline and Evidence Report adopted by the AAOS Board of Directors on September 24, 2010. Accessed at http://www.aaos.org/Research/guidelines/SCFguideline.asp

5 Kumar K, Nguyen R, Bishop S. “A Comparative Analysis of the Results of Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Compression Fractures” Neurosurgery 67[ONS Suppl 1]:ons171-ons1888,2010

6 Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty, Anesthesiol Clin. 2007 Dec;25 (4):913-28

7 Kallmes DF et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361:569-79

8 Buchbinder R,et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009;361:557-68

SOURCE Wayne J. Olan