PARIS, France—Balloon kyphoplasty was significantly better than nonsurgical care at producing sustained improvements in pain, function, and quality of life, Steven Boonen, MD, and colleagues reported at EULAR.¹  Balloon kyphoplasty is a minimally invasive treatment for acute vertebral fractures that reduces and corrects deformity by inserting expandable balloon tamps and stabilizing the vertebral body with injections of bone cement.

“Compared with nonsurgical treatment, balloon kyphoplasty safely improved quality of life and reduced back pain, disability, the use of pain medications, and walking aids. Significant improvements in multiple measurements of quality of life, pain and disability continue for at least 1 year,” said Dr. Boonen, at the center for metabolic bone diseases and division of geriatric medicine, Universitair Ziekenhuis Katholieke Universiteit Leuven in Belgium.

Balloon kyphoplasty: less pain, better function, no increased risk of new fracture

The randomized, controlled trial enrolled patients with up to three nontraumatic acute vertebral compression fractures within 3 months of diagnosis. Patients received either balloon kyphoplasty (N = 149) or usual nonsurgical care (N = 151). Quality of life, back pain and function, and days of disability and bedrest and spine radiographs were assessed through 12 months of follow-up.

Compared with those assigned to nonsurgical care, participants assigned to balloon kyphoplasty had 5.2 points (95% CI, 2.9 to 7.4; P <.0001) greater improvement in the physical component of the SF-36 quality of life questionnaire at 1 month and 1.5 points (95% CI, -0.8 to 3.8; P = .2) at 1 year.

Compared with nonsurgical care, balloon kyphoplasty also significantly improved quality of life by the EuroQol questionnaire at by 0.18 points at 1 month (P = .0003) and by 0.12 points at 12 months (P = .025). The procedure reduced disability by the Roland-Morris scale by 4 points at 1 month (P <.0001) and by 2.6 points at 12 months (P = .0012). Furthermore, the balloon kyphoplasty patients had less back pain at 12 months (0.9 points; 95% CI, 0.3 to 1.5; P = .0034) and reported fewer days of limited activity (1.6; 95% CI, -0.1 to 3.3; P = .068). “Fewer patients assigned to balloon kyphoplasty took pain medications or used walking aids during follow-up,” Dr. Boonen said.

The two groups had similar adverse events profiles. Notably, there were no differences in rates for new radiographically detected vertebral fractures. This has been a concern due to the possibility that stabilizing one section of spine would increase stress forces on adjacent segments.

Reference

1. Boonen S, Wardlaw D, Bastian L, et al. A randomized trial of balloon kyphoplasty and nonsurgical care for patients with acute vertebral compression fractures: one year results.  Presented at: EULAR 2008; June 11-14, 2008; Paris, France. Presentation OP-0025.