A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters

Jan Van Meirhaeghe, Leonard Bastian, Steven Boonen, Jonas Ranstam, John B Tillman, Douglas Wardlaw, FREE investigators, Jan Van Meirhaeghe, Leonard Bastian, Steven Boonen, Jonas Ranstam, John B Tillman, Douglas Wardlaw, FREE investigators

Abstract

Study design: Multicenter randomized controlled trial.

Objective: To compare the efficacy and safety of balloon kyphoplasty (BKP) with nonsurgical management (NSM) during 24 months in patients with painful vertebral compression fractures (VCFs).

Summary of background data: Recently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographical vertebral deformity results.

Methods: Adults with 1 to 3 VCFs were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life assessments and objective functional (timed up and go) and radiographical assessments were collected.

Results: Compared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at 1 month (5.35 points; 95% CI, 3.41-7.30; P < 0.0001) and when averaged across the 24 months (overall treatment effect 2.71 points; 95% CI, 1.34-4.09; P = 0.0001). The kyphoplasty group also had greater functionality by assessing timed up and go (overall treatment effect -2.49 s; 95% CI, -0.82 to -4.15; P = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.13° of correction for kyphoplasty compared with 0.82° in the control, P = 0.003). Number of baseline prevalent fractures (P = 0.0003) and treatment assignment (P = 0.004) are the most predictive variables for PCS improvement; however, in patients who underwent BKP, there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) than the quart having lowest correction of angulation (7.40 points, P = 0.0146 for difference). The most common adverse events temporally related to surgery (i.e., within 30 d) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM), and urinary tract infection (10 BKP, 3 NSM). Several other adverse events were possibly related to patient positioning in the operating room.

Conclusion: Compared with NSM, BKP improves patient quality of life and pain averaged during 24 months and results in better improvement of index vertebral body kyphotic angulation. Perioperative complications may be reduced with more care in patient positioning.

Level of evidence: 2.

Trial registration: ClinicalTrials.gov NCT00211211.

Figures

Figure 1.
Figure 1.
Histogram of index and prevalent fractures for BKP and NSM groups, combined. BKP indicates balloon kyphoplasty; NSM, nonsurgical management.
Figure 2.
Figure 2.
Index vertebral body kyphotic angulation correction and height restoration. Means and 95% confidence intervals are shown for balloon kyphoplasty and nonsurgical management for (A) kyphotic angulation of index fractures; (B) index fracture anterior height as a percent; (C) index fracture midvertebral height as a percent; (D) index fracture posterior height as a percent. Group comparison P values are shown for each time point. The asterisk (*) indicates a statistically significant improvement from baseline postoperatively (P < 0.001). The Friedman P value represents change across all time point for the BKP group. BKP indicates balloon kyphoplasty; NSM, nonsurgical management; postop indicates postoperative; NE, not evaluated.
Figure 3.
Figure 3.
Kyphotic angulation for upper and lower quarts of PCS, VAS, EQ-5D, and RMDQ. The figure shows the kyphotic angulation improvement for the upper and lower quarts for each clinical outcome measure. For each assessment, Shapiro-Wilk normality test was conducted. Based upon this test result, Mann-Whitney U nonparametric test P values are shown for SF-36 PCS and parametric t test P values are shown for VAS, EQ-5D, and RMDQ. EQ-5D indicates EuroQol 5 dimension; VAS, visual analogue scale; RMDQ, Roland-Morris Disability Questionnaire; PCS, physical component summary.

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