Clinical Outcomes
Vertebral Augmentation Clinical Outcomes
Vertebral augmentation (also known as balloon kyphoplasty) is a widely used and well-documented treatment for vertebral compression fractures (VCFs). Clinical outcomes from multiple studies[1][2][3][4][5][6][7] show that vertebral augmentation can potentially result in:
- Rapid and sustained pain relief
- Increased mobility
- Improved quality of life
- Low complication rate
Documented Clinical Outcomes
Fracture Reduction and Evaluation (FREE) Study by D. Wardlaw et al.
According to the FREE study by D. Wardlaw et al.[8] – a multicenter, randomized, controlled trial of 300 patients with VCFs – balloon kyphoplasty resulted in measurably improved back pain, disability and quality of life that persisted for more than two years.
The primary study endpoint was quality of life measured by the physical component (PC) of the SF-36 measured at one month postoperative. Secondary measures included the SF-36 subscales and summary scales, the Euroquol-5D (EQ-5D) global health measure, a Visual Analog Scale and the Roland Morris Disability Questionnaire.
At one month, the SF-36 PC scores had improved 5.1 points (p < 0.0001) more than the scores for the nonsurgical group. At two-year follow-up, the kyphoplasty patients’ baseline SF-36 PC scores had improved by 3 points (p = 0.002).
Additionally, as indicated by VAS scores, the kyphoplasty group showed clinically meaningful pain reduction in as early as seven days. This improvement was sustained throughout the two-year study.
The kyphoplasty patients also reported statistically significant gains in quality of life. The EQ-5D scores improved an average of 0.13 points, more than the non-operative patients at two years, (P = .004).
Multicenter, 155-patient Prospective Study by S.R. Garfin et al.
Study[9] showed that patients treated with balloon kyphoplasty experienced rapid, measurable and sustained improvements in back pain, back function, and quality of life for up to 24 months.
VAS scores decreased from 60% (from 15 to 6 as rated on a scale of 1-20) within seven days after kyphoplasty (p < 0.001) and remained lower throughout the two-year follow-up. At 24 months, 87% of patients (100 patients completing the 24 months) reported no days in bed due to back pain during the preceding 28-day period, compared to only 46% before the procedure.
The ability to perform common activities such as lifting and bending and standing for one hour without difficulty improved from approximately 20% of patients before balloon kyphoplasty to over 50% within one month and persisted or increased through 24 months (p < 0.001). The average number of days per month that back pain limited or qualitatively impacted the patients’ daily activities was reduced by 50 to 81% over the two-year follow-up period when compared to the month before the procedure.
Prospective Study by I.H. Lieberman et al.
Study[10][11] found clinical improvements in pain, mental health and vitality with an average of 6.7 months of follow-up after balloon kyphoplasty in 30 patients. SF-36 scores for bodily pain were 11.6-58.7, (P = 0.0001) and physical function were 11.7-47.4, (P = 0.002).
A Systematic Review by R.S. Taylor et al.
R.S. Taylor et al.[12][13][14] offers evidence that balloon kyphoplasty provides statistically significant pain relief for at least two years. The authors found level III evidence to support the procedure as an effective therapy in the management of patients with symptomatic osteoporotic VCFs refractory to conventional medical therapy.
