Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, notes that the August 10, 2010 online edition of The Lancet includes the largest peer-reviewed study to date demonstrating the efficacy of vertebroplasty in the treatment of acute vertebral compression fractures compared to conservative treatment.
The article, titled “Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open label randomised trial,” was authored by Drs. Klazen and Lohle et al and described the methods and findings of a 202-patient study conducted in the Netherlands and Belgium between October 1, 2005 and June 30, 2008.
Vertebroplasty is a minimally invasive procedure involving the percutaneous injection of bone cement into a fractured vertebral body, effectively reducing pain. Orthovita received FDA clearance in June 2009 for Cortoss™ Bone Augmentation Material, a synthetic biomaterial, for use in vertebroplasty as an alternative to polymethylmethacrylate (PMMA) bone cement. Although PMMA and not Cortoss was used in the Vertos II study, in a 256-patient IDE vertebral augmentation study submitted to the FDA, Cortoss demonstrated non-inferiority to PMMA and statistically significant superiority in pain relief at 3 months and mobility at 24 months. In August 2009, the New England Journal of Medicine published two studies which seemed to indicate that a “sham” procedure and vertebroplasty were equally effective. According to the Vertos II investigators, the clinical interpretation of the NEJM studies is thwarted by the inclusion of patients with subacute and chronic fractures instead of acute fractures, and other methodological issues. The stated intention of the investigators in the Vertos II study was therefore “to clarify whether percutaneous vertebroplasty has additional value compared with optimum pain treatment in a well defined group of patients with acute vertebral compression fractures.”
The Vertos II study randomized 202 elderly patients with acute painful vertebral fractures who were treated with either vertebroplasty or conservative care and followed for one year. Conservative care included optimized analgesic regimens, bed rest and physical therapy. According to the authors, “Decrease in VAS score after vertebroplasty was significantly higher than with conservative treatment at all timepoints.” In addition, the vertebroplasty patients, who had significantly more disability and lower quality of life scores at baseline, showed significantly faster and greater improvements than conservatively treated patients for these parameters. The authors concluded that, “Pain relief after the procedure is immediate, sustained for 1 year, and is significantly better than that achieved with conservative treatment and at acceptable costs.” No serious complications or adverse events were reported in the study.
“Contrary to the conclusions published in the NEJM, the results of the Vertos II study show that vertebroplasty is an effective treatment of acute painful osteoporotic fractures in properly selected patients. Important differences between the studies are both the degree of pain and the number of weeks or months that the patients needed to be in pain before being considered for treatment,” said Dr. Maarten Persenaire, Chief Medical Officer of Orthovita. “One of the strengths of the Vertos II study is its applicability in routine care where patients with acute pain first undergo imaging and other tests to diagnose the cause and assess their overall state of health. By the time all results necessary for treatment selection have been received, about half of patients with fractures may have improved enough to warrant continued conservative measures. The study shows the remaining patients stand to gain significant benefits from vertebroplasty.”