The final results of the FREE (Fracture Reduction Evaluation) international, multicentre, randomised controlled trial with two-year follow-up, comparing balloon kyphoplasty to non-surgical management for the treatment of painful vertebral compression fractures was presented at the 35th Annual Meeting of the Society of Interventional Radiology, Tampa, USA.
“Kyphoplasty is an effective and safe early treatment option for patients with acute vertebral compression fractures,” said Douglas Wardlaw, consultant orthopaedic and spinal surgeon, Woodend Hospital, UK.
“Balloon kyphoplasty treatment effect over two years is significant for improving physical symptoms, disability and global health outcome. Early improvement is seen in the case of balloon kyphoplasty patients and pain reduction is significantly better when compared to non-surgical management patients over the complete two-year follow-up period,” he said. Wardlaw pointed out that balloon kyphoplasty patients had less cumulative pain and that the pain was reduced at a faster rate in the group of patients undergoing balloon kyphoplasty. They had about 112 more days of activity at two-year follow-up when compared to those treated by non-surgical management.
“In addition,” said Wardlaw, “There was a low rate of complications reported and no statistical difference between treatment groups for subsequent fractures.
“FREE is the first randomised study comparing kyphoplasty to nonsurgical management — the standard of care — for treating acute vertebral compression fractures,” Wardlaw told delegates.
The study included 300 patients treated at 21 sites in eight countries. Mean patient age was 73 years; 78% of study participants were women. Primary osteoporosis caused most of the injuries in patients with vertebral body compression fractures.
The primary end point was quality of life measured by the physical component summary (PCS) score of the SF-36 at one month. For secondary measures, they used the SF-36 subscales and summary scales, the Euroquol-5D (EQ-5D) global health measure, the Visual Analog Score for back pain, the Roland Morris Disability Questionnaire and pain medication usage.
Kyphoplasty patients were treated by percutaneous, bilateral approach, while non-surgical treatment was based on the standard practices of each participating hospital.
At one month, the mean SF-36 PCS score improved 5.1 points in the kyphoplasty group more than in the nonsurgical group ( p<0.0001). The PCS score improved by an average of three points during the two-year follow-up ( p=0.002) for these patients. Compared to non-operative patients, kyphoplasty patients reported statistically significant improvements in quality of life, Wardlaw said. The EQ-5D scores improved an average of 0.13 points more than non-operative patients over two years (p=0.004).
With regard to the two recent trials published in the NEJM in August 2009 by Kallmes et al and Buchbinder et al which found no real benefit for verterboplasty vs. a sham injection, Wardlaw told delegates that there was no valid comparison between those studies and the FREE trial.
“There is no real science in comparing these papers with the FREE study because the indications are different (three months vs. one year) and the procedures are completely different,” he said.