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Balloon kyphoplasty improved quality of life, reduced back pain and disability
The minimally invasive procedure offered advantages to nonsurgical treatment in managing vertebral body compression fractures.
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BRUSSELS — Short-term results from a recent international study indicate that balloon kyphoplasty can treat vertebral body compression fractures successfully by expanding the fractures and filling them with bone cement.
The results are the first international findings to be reported from the Fracture Reduction Evaluation (FREE Study), the first prospective, randomized, controlled multicenter trial designed to compare balloon kyphoplasty to nonsurgical management of painful, acute vertebral fractures.
Investigators reported similar results late last year with U.S. patients in the journal Spine.
In the European study, patients with one to three nontraumatic vertebral compression fractures diagnosed within 3 months postinjury were randomly assigned to receive either balloon kyphoplasty (n=149 patients) or traditional nonsurgical care (n=151).
Investigators from several European countries, including Belgium, the United Kingdom, Sweden and Germany, measured patients' physical quality of life, back pain and function, as well as days of disability and bed rest at baseline and 1-month postinjury in the nonsurgical control group and 1- month postsurgery in the balloon kyphoplasty group, said Douglas Wardlaw, FRCS, who presented results at the 9th Annual Meeting of the Spine Society of Europe, here.
Comparing the 1-month changes in both groups, investigators said that patients who underwent balloon kyphoplasty experienced greater improvement in the physical component portion of the SF-36 questionnaire, the total European Quality of Life (EQ-5D) score, the Roland-Morris Disability Index, and in pain ratings. There was no difference between the groups in the number of serious adverse events.
There was one device-related (soft tissue hematoma), one procedure-related (postoperative urinary tract infection) and no bone cement-related serious adverse effects in the kyphoplasty group.
"These findings offer important insight into the potential benefits of balloon kyphoplasty as one treatment for osteoporotic spine fractures," Wardlaw said.
Researchers said they expect to report on 2-year results in 2009.
For more information:
- Orthopedics Today could not determine if the authors had any financial conflict of interest to disclose.
- Wardlaw D, Boonen S, Bastian L, Van Meirhaeghe J. An International multicenter randomized comparison of balloon kyphoplasty and nonsurgical care in patients with acute vertebral body compression fractures. #45. Presented at the 9th Annual Meeting of the Spine Society of Europe. Oct. 2-6, 2007. Brussels.