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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.
Explore additional clinical data for vertebroplasty and balloon kyphoplasty procedures.EXPLORE CLINICAL DATA
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.