Balloon Kyphoplasty Not Much Better Than Conservative Therapy
Vertebral fractures of the back can be very painful. Balloon kyphoplasty can improve this pain compared to conservative therapy, but by 24 months there is no statistically difference.
Douglas Wardlaw (Woodend Hospital, Aberdeen, UK) and colleagues report has been published online ahead of print in the Journal of Bone and Mineral Research, February 2011.
Their report notes that although “most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points.”
Vertebral compression fractures affect approximately 25% of all postmenopausal women in the United States. The prevalence of this condition steadily increases with advancing age, reaching 40% in women 80 years of age. Although less common in older men, compression fractures also are a major health concern in this group.
Wardlaw and colleagues compared the efficacy and safety of balloon kyphoplasty to non-surgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or non-surgical therapy (n = 151).
The researchers used the 100-point short-form (SF)-36 physical component summary (PCS) score to assess the patients' physical ability at regular intervals through the study period. They also assessed QoL, safety, and other efficacy measures.
Kyphoplasty was associated with greater overall improvements in SF-36 PCS scores when averaged across the 24-month follow-up period, compared with non-surgical therapy (overall treatment effect 3.24 points, 95% confidence interval [CI] 1.47–5.01; p = 0.0004).
This treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13–5.64; p = 0.003) but not at 12 (1.70 points, 95% CI −0.59 to 3.98; p = 0.15) or 24 months (1.68 points, 95% CI −0.63 to 3.99; p = 0.15).
Looking only at the pain component, greater improvement was observed over the 24 months for kyphoplasty (overall treatment effect −1.49 points, 95% CI −1.88 to −1.10; p
The researchers note the closing of the gap between the two groups was due to an eventual improvement in physical ability among patients in the non-surgical care group over the 24 months.
There were two device-related serious adverse events in the second year that occurred in the kyphoplasty group: a spondylitis and an anterior cement migration.
It is estimated that approximately 150,000 patients in the United States are hospitalized each year with compression fractures. There stay in the hospital can average 8 days. The overall resulting costs are estimated to exceed $1.6 billion.
It is important to be able to show that a minimally invasive procedure like the balloon kyphoplasty is helpful in treating these fractures. Even though this study notes that compared with non-surgical management, kyphoplasty rapidly reduces pain and improves function, disability, and QOL, it is a small study.
Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial; Boonen S, Van Meirhaeghe J, Bastian L, Cummings SR, Ranstam J, Tillman JB, Eastell R, Talmadge K, Wardlaw D; Journal of Bone and Mineral Research published online February 2011; DOI: 10.1002/jbmr.364
Vertebral Compression Fractures in the Elderly; Old JL, Calvert M; Am Fam Physician. 2004 Jan 1;69(1):111-116.