Elsevier

The Lancet

Volume 373, Issue 9668, 21–27 March 2009, Pages 1016-1024
The Lancet

Articles
Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial

https://doi.org/10.1016/S0140-6736(09)60010-6Get rights and content

Summary

Background

Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure.

Methods

Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0–100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211.

Findings

138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7·2 points (95% CI 5·7–8·8), from 26·0 at baseline to 33·4 at 1 month, in the kyphoplasty group, and by 2·0 points (0·4–3·6), from 25·5 to 27·4, in the non-surgical group (difference between groups 5·2 points, 2·9–7·4; p<0·0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure.

Interpretation

Our findings suggest that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option.

Funding

Medtronic Spine LLC.

Introduction

Every year an estimated 1·4 million vertebral compression fractures that cause pain and disability and diminish quality of life1, 2 come to clinical attention worldwide.3 Despite non-surgical management, including analgesia, bed rest, physiotherapy, and back bracing, pain sometimes resolves slowly, and can persist.4 The resulting vertebral deformity can cause height loss, kyphosis, reduced pulmonary function, and mobility and balance impairment.4, 5, 6 Vertebral fracture is associated with an increased risk of future fractures.7

Since conventional open surgery for vertebral fractures is associated with risks resulting from open reduction and internal fixation, it is usually reserved for fractures that cause neurological impairment. Balloon kyphoplasty is a minimally invasive procedure that is intended to reduce pain, disability, and vertebral deformity by use of catheters with inflatable bone tamps placed inside the affected vertebral body. Balloon inflation compacts the cancellous bone and pushes the endplates apart, which might partly restore height and correct angular deformity.8 Once the balloons have been removed, the resulting void is filled with viscous bone cement to stabilise the vertebral body. The procedure can be done under general anaesthesia or conscious sedation, either as a day case, or with an overnight stay, dependent on medical need. Although investigators have reported reduced pain and improved function after kyphoplasty treatment,9, 10, 11 there are no data from randomised trials assessing its efficacy and safety. We compared the efficacy and safety of kyphoplasty with non-surgical management for the treatment of acute vertebral compression fractures, to test the hypothesis that kyphoplasty would result in increased improvement in quality of life.

Section snippets

Participants

We undertook a randomised controlled trial (Fracture Reduction Evaluation [FREE] trial) at 21 sites in eight countries between February, 2003, and December, 2005. Patients were eligible for enrolment if they had one to three vertebral fractures from T5 through L5. At least one fracture needed to have oedema assessed by MRI and at least one had to show a 15% loss of height or more; single fractures were to meet both these criteria. Patients with fractures due to osteopenia arising from primary

Results

300 patients were screened and randomly assigned to balloon kyphoplasty (n=149) or non-surgical care (n=151; figure 1). Table 1 shows the baseline characteristics of the enrolled participants. Of the ten patients assigned to kyphoplasty treatment who did not have the procedure, one underwent vertebroplasty because the investigator judged that kyphoplasty was no longer feasible (figure 1). 14 patients assigned to the control group withdrew and underwent surgery; five of these patients had

Discussion

This randomised controlled trial showed that in patients with acute, painful, vertebral fractures, balloon kyphoplasty improved quality of life, function, mobility, and pain more rapidly than did non-surgical management, with significant differences in improvement between the groups at 1 month. For most outcome measures, the differences between kyphoplasty treatment and control were diminished at 12 months because the non-surgical group improved over time, probably as a result of fracture

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