In the largest randomized controlled trial comparing balloon kyphoplasty (BKP) to non-surgical management (NSM) in patients with osteoporosis, balloon kyphoplasty was shown to be more effective than non-surgical management for the treatment of acute vertebral compression fractures (VCFs) at 12 months1 and 24 months2.
BKP patients experienced 3 times greater pain reduction at 1 week compared to NSM patients.
Significantly better pain relief results were seen at 1 month and maintained for up to 2 years versus NSM.
Pain relief was associated with fewer BKP patients using pain medications through 12 months and opioids through 6 months than NSM patients.
BKP patients experienced 4 times greater improvement in quality of life at 1 month compared to NSM patients.
Significantly improved quality of life when averaged across two years vs non-surgical management.
BKP was superior to non-surgical management when measured by SF-36 PCS at one month.
On average through 24 months, BKP patients experienced significantly better quality of life than patients treated non-surgical as measured by EQ-5D and SF-36 PCS.
BKP patients experienced 5 fewer days of restricted activity at1month compared to baseline.
Rapid return to daily activities maintained up to 2 years vs. NSM
BKP patients has an estimated 136 more days of activity over the 24-month period than those receiving non-surgical management
BKP patients had significantly better back function than non-surgical management patients on average through 24-month as measure by Roland-Morris Score.
BKP patients were significantly more satisfied than those treated non-surgically at all time points through 24 months.
There were similarities in overall frequencies of adverse events and serious adverse events between treatment groups during the 24-month study.2
Balloon kyphoplasty was shown to be more effective than non-surgical management for the treatment of acute VCFs.
Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009 Mar 21;373(9668):1016-24.
Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637.
Non-surgical group received analgesics, bed rest, back braces, physiotherapy, rehabilitation programs, and walking aids according to standard practices of participating hospitals.