title: A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up.
abstract: METHODS
  Randomized, controlled, prospective (AAOS therapeutic level I) trial conducted under Food and Drug Administration Investigational Device Exemption hypothesized noninferiority of a novel bioactive composite material to polymethylmethacrylate (PMMA).
  
  
  OBJECTIVE
  To determine the safety and efficacy of a new, nonresorbable bioactive composite (Cortoss) compared with PMMA, the standard treatment of vertebral compression fractures (VCFs).
  
  
  BACKGROUND
  Vertebroplasty with PMMA, the widely adopted treatment for VCFs nonresponsive to conservative care, provides effective, immediate pain relief, but the material has received criticism for its properties. A new bioactive composite material designed specifically for vertebroplasty showed promising results in animals and nonrandomized clinical studies and was subsequently compared with PMMA in a randomized study. This study represents the first prospective study evaluating vertebroplasty comparing PMMA with another material with 24-month follow-up.
  
  
  METHODS
  Using 2:1 randomization, vertebroplasty was performed with Cortoss on 162 patients and PMMA on 94 patients. Inclusion criteria were painful osteoporotic VCFs with a visual analogue scale pain score of at least 50 mm on a 100-mm scale and at least 30% disability as measured by the Oswestry Disability Index. Evaluations at pretreatment, treatment day, and 7 posttreatment intervals out to 24 months included pain, disability, neurological status, adverse events, quality of life, patient satisfaction, analgesic use, and independently reviewed radiographs.
  
  
  RESULTS
  Noninferiority of Cortoss relative to PMMA was observed, with Cortoss-treated patients experiencing significant pain relief at 3 months (P = 0.0395) and better maintenance or improvement in function at 24 months (P = 0.0299). Incidence of serious device-related adverse events was 4.3% in both groups; none were life threatening.
  
  
  CONCLUSIONS
  Vertebroplasty using either Cortoss or PMMA provides effective, immediate, and lasting pain relief and prevents further loss of function. Both materials performed comparably at most time points; Cortoss demonstrated better results for pain reduction at 3 months and for function at 24 months.
authors: Spine Institute, St John's Health Center, Santa Monica, CA, USA. baehw@yahoo.com
authors: Hyun
authors: H
authors: Bae
authors: Homer Paul
authors: HP
authors: Hatten
authors: Raymond
authors: R
authors: Linovitz
authors: A David
authors: AD
authors: Tahernia
authors: Michael K
authors: MK
authors: Schaufele
authors: Vance
authors: V
authors: McCollom
authors: Louis
authors: L
authors: Gilula
authors: Philip
authors: P
authors: Maurer
authors: Ramsin
authors: R
authors: Benyamin
authors: John M
authors: JM
authors: Mathis
authors: Maarten
authors: M
authors: Persenaire
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017438:Bisphenol A-Glycidyl Methacrylate / Q000627:therapeutic use*; D057186:Comparative Effectiveness Research; D005260:Female; D005500:Follow-Up Studies; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D019904:Polymethyl Methacrylate / Q000627:therapeutic use*; D011446:Prospective Studies; D016103:Spinal Fractures / Q000601:surgery*; D016896:Treatment Outcome; D054854:Vertebroplasty / Q000295:instrumentation* / Q000379:methods
chemical_list: C475778:CORTOSS; D017438:Bisphenol A-Glycidyl Methacrylate; D019904:Polymethyl Methacrylate