A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis

Abstract

Background and purpose: Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty.

Materials and methods: Patients with osteoporosis with 1-3 acute fractures (T5-L5) were randomized and treated with kyphoplasty (n = 191) or vertebroplasty (n = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled.

Results: The average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, P < .001). At 12 months, 7.8% fewer patients with kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant (P > .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, P = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, P = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed.

Conclusions: Kyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival.

© 2014 by American Journal of Neuroradiology.

Figures

Fig 1.

Patient accountability.

Fig 2.

Distribution of index and prevalent fractures and those with edema and vacuum cleft for the BKP and VP groups combined. Index levels (those identified as treatment levels) and prevalent fractures (all radiographic fractures assessed by the core laboratory) are shown, identified from standing lateral x-ray films with 379 of 381 treated patients contributing data. The distribution of levels with edema and those with vacuum cleft is shown on the basis of available MR imaging at baseline (294 of 381 treated patients).

Fig 3.

Kaplan-Meier survival analysis for new clinical fractures.

Fig 4.

Quality-of-life, disability, and pain assessments at baseline and after balloon kyphoplasty or vertebroplasty. Means and 95% confidence intervals are shown for balloon kyphoplasty (solid lines) and vertebroplasty (dashed lines) for the SF-36 Physical Component Summary (scale 0–100) (A); the total EQ-5D scores (scale 0–1) (B); back pain (scale 0–10) (C); and the Oswestry Disability Index (scale 0–100) (D). The treatment P value in each panel indicates the comparison between groups. Below each panel, the n for each group is shown for baseline, 3, 12, and 24 months and the group average for change from baseline and 95% CI for 3, 12, and 24 months. The asterisk indicates P < .001 for all change from baseline scores.

Fig 5.

Cement extravasation. The percentage of treated vertebrae in each treatment group having cement extravasation, measured by using postoperative CT, is shown; results are based on evaluable CT data for 168/191 patients with BKP and 160/190 with VP, accounting for 214/244 and 201/233 levels, respectively. Fischer exact P values comparing the 2 treatment groups for each category are shown.