title: Vertebral body stenting versus kyphoplasty for the treatment of osteoporotic vertebral compression fractures: a randomized trial.
abstract: BACKGROUND
  In the treatment of vertebral compression fractures, vertebral body stenting with an expandable scaffold inserted before application of the bone cement was developed to impede secondary loss of vertebral height encountered in patients treated with balloon kyphoplasty. The purpose of this study was to clarify whether there are relevant differences between balloon kyphoplasty and vertebral body stenting with regard to perioperative and postoperative findings.
  
  
  METHODS
  In a two-armed randomized controlled trial, patients with a total of 100 fresh osteoporotic vertebral compression fractures were treated with either balloon kyphoplasty or vertebral body stenting. The primary outcome was the post-interventional change in the kyphotic angle on radiographs. The secondary outcomes were the maximum pressure of the balloon tamp during inflation, radiation exposure time, perioperative complications, and cement leakage.
  
  
  RESULTS
  The mean reduction (and standard deviation) of kyphosis (the kyphotic correction angle) was 4.5° ± 3.6° after balloon kyphoplasty and 4.7° ± 4.2° after vertebral body stenting (p = 0.972). The mean pressures were 24 ± 5 bar (348 ± 72 pounds per square inch [psi]) during vertebral body stenting and 16 ± 6 bar (233 ± 81 psi) during balloon kyphoplasty (p = 0.014). There were no significant differences in radiation exposure time.None of the patients underwent revision surgery, and postoperative neurologic sequelae were not observed. Cement leakage occurred at twenty-five of the 100 vertebral levels without significant differences between the two intervention arms (p = 0.230). Intraoperative material-related complications were observed at one of the fifty vertebral levels in the balloon kyphoplasty group and at nine of the fifty levels in the vertebral body stenting group.
  
  
  CONCLUSIONS
  No beneficial effect of vertebral body stenting over balloon kyphoplasty was found among patients with painful osteoporotic vertebral fractures with regard to kyphotic correction, cement leakage, radiation exposure time, or neurologic sequelae. Vertebral body stenting was associated with significantly higher pressures during balloon inflation and more material-related complications.
authors.affiliation: Division of Trauma Surgery, Department of Surgery, University of Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. Clement.Werner@usz.ch
authors.forename: Clément M L
authors.initials: CM
authors.lastname: Werner
authors.forename: Georg
authors.initials: G
authors.lastname: Osterhoff
authors.forename: Jannis
authors.initials: J
authors.lastname: Schlickeiser
authors.forename: Raphael
authors.initials: R
authors.lastname: Jenni
authors.forename: Guido A
authors.initials: GA
authors.lastname: Wanner
authors.forename: Christian
authors.initials: C
authors.lastname: Ossendorf
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Simmen
mesh_terms: D000368:Aged; D001843:Bone Cements; D016009:Chi-Square Distribution; D005119:Extravasation of Diagnostic and Therapeutic Materials; D005260:Female; D050815:Fractures, Compression / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D058498:Kyphoplasty / Q000379:methods*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000175:diagnosis / Q000601:surgery*; D019904:Polymethyl Methacrylate; D011446:Prospective Studies; D016103:Spinal Fractures / Q000175:diagnosis / Q000601:surgery*; D018709:Statistics, Nonparametric; D015607:Stents; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D001843:Bone Cements; D019904:Polymethyl Methacrylate