Balloon kyphoplasty shows safety and efficacy in improving quality of life, pain, and functional outcomes, while reducing opioid use, among patients treated for vertebral compression fractures (VCFs).
It was found that all primary endpoints demonstrated statistical improvement and these were maintained or improved throughout a 12-month follow-up.
Secondary endpoints, including opioid usage, activity, angulation correction, and height restoration, also showed statistical improvement.
In balloon kyphoplasty, a minimally invasive treatment for VCFs caused by bones weakened from osteoporosis or cancer, the compressed bone is gently raised to its normal position and the cavity created is filled with orthopedic cement to stabilize the fracture.
The procedure differs from vertebroplasty only in the use of the balloon approach.
This, the largest prospective outcomes trial for kyphoplasty to date, involved 350 patients with painful, acute, or subacute VCF who were enrolled at 24 sites and underwent kyphoplasty.
The patients had a mean age of 78 years; 77% were female. All had one to three acute or subacute fractures less than 4 months old. Approximately half (54.9%) had bilateral kyphoplasty.
Most patients had VCF due to osteoporosis (343 of 350), and the remaining cases were due to cancer.
The patients' average pain scores were greater than 7 on a scale of 1 to 10, and disability on the Oswestry Disability Index (ODI) was greater than 30 on a scale of 0 to 100.
Follow-up data collected at 1-, 3-, 6-, and 12-month time points showed significant improvements in various measures.
In terms of the primary endpoints, patients showed significant improvements in the numeric rating scale for back pain, from an average of 8.7 at baseline (on a scale of 0 to 10) to 3.3 at 1 month, 2.7 at 3 months, 2.5 at 6 months, and 2.4 at 12 months.
Disability measures on the ODI showed improvement from 63.4 (on a 0-to-100 scale) to 32.9, 28.1, 27.1, and 27.2 at these time points, respectively.
Measures of quality of life improved to 34.9, 36.6, 36.6, 37.6, and 38 at the same time points.
Average score on the EuroQol-5-domain, which also assesses quality of life, improved from 0.383 points (scale of 0 to 1) at baseline to 0.693, 0.731, 0.739, and 0.741, respectively.
All improvements were statistically significant.
Importantly, the percentage of patients taking opioids dropped from 71.5% at baseline to 55.3% at 12 months.
The mean number of days with limited activity per month declined significantly from about 11 days to approximately 2 over the 12-month follow-up (P < .001 for all time points). The mean number of bed-rest days also dropped sharply from six per month to less than one (P < .001 for all time points).
In terms of measures of kyphotic angulation and vertebral height improvement, index fracture midline height improvements were observed at postoperative and 3-month time points, as well as at the 12-month time point.
In terms of adverse events, there were five device- or procedure-related events (1.46%), all of which resolved with appropriate treatment.
The current findings are notable in light of previous research questioning the benefits of vertebroplasty, including a study in the New England Journal of Medicine showing no improvement from the procedure over a sham treatment at all time points up to 6 months.
With as many as 40% of people over the age of 80 having had developed VCFs during their lifetime, and about 1.5 million people developing VCFs annually, the development of kyphoplasty is a very positive.
The findings build on previous evidence of potential benefits of kyphoplasty.
This study adds further evidence that kyphoplasty can be effective in treating painful osteoporotic compression fractures.
Previous randomized comparative studies have also shown benefit of balloon kyphoplasty vs medical treatment.
For more information on Kyphoplasty, contact Comprehensive Pain Management in our various loactions.