title: Clinical experience using Cortoss for treating vertebral compression fractures with vertebroplasty and kyphoplasty: twenty four-month follow-up.
abstract: METHODS
  Forty patients were enrolled in 2 FDA-approved pilot Investigational Device Exemption (IDE) studies using Cortoss for the treatment of vertebral compression fractures (VCF). Twenty patients were treated at 3 centers, using vertebroplasty (VP) and 20 patients were treated at 5 centers, using kyphoplasty (KP).
  
  
  OBJECTIVE
  To assess the feasibility and clinical outcomes using Cortoss to treat osteoporotic VCF.
  
  
  BACKGROUND
  Cortoss is an injectable bioactive, self-setting, radiopaque composite shown to stabilize and provide immediate weight bearing support to fractured vertebrae. Cortoss is approved for use in Europe for both screw and vertebral augmentation. METHODS.: Patient assessments were conducted before surgery and after surgery through 24 months using Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and quality-of-life assessment (SF-12) questionnaires. Extravasations were evaluated using radiographs and CT scans.
  
  
  RESULTS
  Immediate pain improvement was seen in VP patients with VAS scores decreasing from 75.7 before surgery to 35.9 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 48.9). Disability improved with average ODI scores decreasing from 52.2% preoperative to 38.3% at 2 years for VP patients. Immediate pain improvement was also seen in KP patients with VAS scores decreasing from 78.1 before surgery to 42.7 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 25.4). ODI scores improved from 60.5% preoperative to 34.5% at 2 years for KP patients. Average material volumes injected were 1.85 mL for VP and 4.13 mL for KP. Extravasations from both techniques were minor, anatomically close to the treated vertebrae and asymptomatic. No cardiac irregularities or pulmonary emboli were observed.
  
  
  CONCLUSIONS
  These studies indicate Cortoss is safe and effective in treating osteoporotic VCF using vertebroplasty or kyphoplasty. Pain relief and restoration of function with Cortoss is comparable to results found in the literature for polymethylmethacrylate.
authors.affiliation: The Spine Institute, Santa Monica, CA, USA. hbae@laspineinstitute.com
authors.forename: Hyun
authors.initials: H
authors.lastname: Bae
authors.forename: Michael
authors.initials: M
authors.lastname: Shen
authors.forename: Philip
authors.initials: P
authors.lastname: Maurer
authors.forename: Walter
authors.initials: W
authors.lastname: Peppelman
authors.forename: William
authors.initials: W
authors.lastname: Beutler
authors.forename: Raymond
authors.initials: R
authors.lastname: Linovitz
authors.forename: Erik
authors.initials: E
authors.lastname: Westerlund
authors.forename: Timothy
authors.initials: T
authors.lastname: Peppers
authors.forename: Isador
authors.initials: I
authors.lastname: Lieberman
authors.forename: Choll
authors.initials: C
authors.lastname: Kim
authors.forename: Federico
authors.initials: F
authors.lastname: Girardi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017438:Bisphenol A-Glycidyl Methacrylate / Q000009:adverse effects / Q000627:therapeutic use*; D004185:Disability Evaluation; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D058498:Kyphoplasty / Q000379:methods*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D016103:Spinal Fractures / Q000601:surgery*; D016896:Treatment Outcome; D054854:Vertebroplasty / Q000379:methods*
chemical_list: C475778:CORTOSS; D017438:Bisphenol A-Glycidyl Methacrylate