AAOS Fails to Consider New Research Offering Level 1 Evidence in Favor of Vertebroplasty

DAYTON, Ohio, Nov. 29, 2010 /PRNewswire/ -- Results of a large-scale study, "Vertebroplasty vs. Conservative Treatment in Osteoporotic Vertebral Compression Fractures" (VERTOS II), provides Level 1 evidence that vertebroplasty helps relieve the pain caused by vertebral compression fractures at an acceptable cost.(1) The study also helps define the type of patient for whom the procedure is most suitable and effective.(1)

Level 1 evidence refers to studies done under the strictest scientific guidelines, including randomization.

In VERTOS II, Caroline Klazen, a radiologist at St. Elisabeth Hospital in Tilburg, The Netherlands, and her colleagues sought to clarify whether vertebroplasty had "additional value compared with optimum pain treatment in a well-defined group of patients with acute vertebral compression fractures."(1)

Vertebral compression fractures (VCFs) are the most common complication of osteoporosis(2), with an estimated 1.4 million new fractures occurring annually worldwide.(3) Treatment focuses on relieving pain and restoring mobility and function. Historically, vertebroplasty has offered a safe, efficacious and durable treatment that stabilizes the collapsed vertebral body by injecting bone cement into the fracture, resulting in pain relief for 85 to 90 percent of patients.(4,5,6)

For the study, 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.(1)

Published in The Lancet earlier this year, VERTOS II was not part of the literature reviewed by the American Academy of Orthopaedic Surgeons (AAOS) that formed the basis for the group's new clinical practice guideline recommending against vertebroplasty for osteoporotic VCFs. Instead, AAOS leaned heavily on two randomized, controlled clinical trials – Kallmes et al and Buchbinder et al – that appeared in the New England Journal of Medicine (NEJM) in 2009.(7,8) They compared vertebroplasty against a placebo procedure, concluding that there was no statistically significant difference between the two.(7,8)

"But was there enough data in the NEJM studies to substantiate the negative recommendation? I would argue no," says Dr. Mubin Syed, MD, a neuroradiologist and interventional radiologist. "Both studies have been criticized for numerous issues, including enrolling patients with sub-acute and chronic fractures up to a year old, inconsistent use of bone edema on MRI as an inclusion criterion, inadequate sample size, the high crossover from placebo to vertebroplasty, and the lack of a control group."

"In contrast," says Dr. Syed, "VERTOS II is the world's largest prospective, randomized, controlled study for vertebroplasty to date. It included enough patients to record statistically significant data. It consistently used bone edema as an inclusion criterion. And it compared vertebroplasty with a conservative treatment, thereby providing clinicians with directly applicable information about how to best treat patients."

"VERTOS II concluded that in a subgroup of patients with acute osteoporotic VCFs and persistent pain, percutaneous vertebroplasty is effective and safe," continues Dr. Syed. "Pain relief is immediate, sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. These are powerful findings in favor of vertebroplasty that AAOS should not ignore."

VERTOS II also demonstrates the importance of patient selection.

"As is true in many areas of spinal care, appropriate patient selection is vital to the success of any treatment," explains Dr. Syed. "VERTOS II and other studies show that MRI to determine the source of the pain, early treatment of acute fractures within five to six weeks after symptoms start, and post-procedure management of patients by practitioners skilled in osteoporosis treatment are key factors that make vertebroplasty a useful procedure for treating VCFs."

As for the AAOS clinical practice guideline, Dr. Syed would like to see the group revisit its vertebroplasty recommendation and include VERTOS II and other new studies in their research analysis.

"The NEJM trials have methodology defects and are therefore insufficient to conclusively disprove the clinical efficacy of vertebroplasty. Before surgeons decide on which procedures are or aren't effective," says Dr. Syed, "they need to make sure that the evidence used to inform their treatment decisions is conclusive. Don't needlessly deny patients the benefits of vertebroplasty based on incomplete, indeterminate research."

Dr. Syed is on staff at Good Samaritan Hospital and Dayton Heart Hospital in Dayton. He is also a founding partner of Dayton Interventional Radiology. In addition, Dr. Syed has participated in multiple clinical trials and published several papers on vertebroplasty.

Disclosures:

Dr. Mubin Syed is a consultant with Stryker Interventional Spine and Boston Scientific. He conducts vertebroplasty courses and cadaver workshops supported by Stryker Interventional Spine and Arthrocare.

References:

(1) 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

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

(3) Johnell O, Kanis JA. An Estimate of the Worldwide Prevalence and Disability Associated with Osteoporotic Fractures. Osteoporos Int 2006; 726-333

(4) Jensen ME, McGraw JK, Cardella JF, Hirsch JA. "Position Statement On Percutaneous Vertebral Augmentation: A Consensus Statement Developed By the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology" J Vasc Interv Radiol 2009; 20:S326-S331

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

(6) Syed M, Jan S., Patel NA, Harron MS, Gibbs R, Morar K, Shaikh A, Darr R. "Vertebroplasty: The Alternative Treatment for Osteoporotic Vertebral Compression Fractures in the Elderly" Clinical Geriatrics 2006 Feb: Volume 14, Number 2: 20-24

(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 Mubin I. Syed, MD, FACR, FSIR