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


RESULTS
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.


CONCLUSIONS
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.
Wardlaw
Douglas
D
Orthopaedic Department, Woodend Hospital, NHS Grampian, Aberdeen, UK.
Cummings
Steven R
SR
Van Meirhaeghe
Jan
J
Bastian
Leonard
L
Tillman
John B
JB
Ranstam
Jonas
J
Eastell
Richard
R
Shabe
Peter
P
Talmadge
Karen
K
Boonen
Steven
S
D000368:Aged; D001416:Back Pain / Q000209:etiology / Q000517:prevention & control; D001843:Bone Cements / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D050815:Fractures, Compression / Q000150:complications / Q000628:therapy*; D006406:Hematoma / Q000209:etiology; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D011788:Quality of Life; D011859:Radiography; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D016103:Spinal Fractures / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D014552:Urinary Tract Infections / Q000209:etiology; D054854:Vertebroplasty / Q000009:adverse effects / Q000379:methods*
D001843:Bone Cements