title: [Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures].
abstract: BACKGROUND
  As a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated.
  
  
  METHODS
  The pilot study included 24 patients (mean age 74 years, 34 vertebrae).
  
  
  RESULTS
  During an operation period of 16.6 minutes on average 2.2 ± 1 mL of PMMA cement were injected. 87 % of patients were satisfied or very satisfied with this treatment. In 2 cases leakage of cement has been registered. The pain intensity was already reduced after 7 days to 69.5 mm (VAS scale 0-100). After 30 days, the difference from baseline was 76 mm. Significant improvements have also been shown in the Oswestry Score (functional ability), physical performance and mental well-being.
  
  
  CONCLUSIONS
  On the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.
authors.affiliation: Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn. rahel.bornemann@googlemail.com
authors.forename: R
authors.initials: R
authors.lastname: Bornemann
authors.forename: L A
authors.initials: LA
authors.lastname: Otten
authors.forename: E M W
authors.initials: EM
authors.lastname: Koch
authors.forename: T R
authors.initials: TR
authors.lastname: Jansen
authors.forename: K
authors.initials: K
authors.lastname: Kabir
authors.forename: D C
authors.initials: DC
authors.lastname: Wirtz
authors.forename: R
authors.initials: R
authors.lastname: Pflugmacher
mesh_terms: D000368:Aged; D001843:Bone Cements / Q000627:therapeutic use*; D019544:Equipment Failure Analysis; D005260:Female; D050815:Fractures, Compression / Q000150:complications / Q000628:therapy*; D006801:Humans; D016268:Internal Fixators; D008297:Male; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010865:Pilot Projects; D011474:Prosthesis Design; D016103:Spinal Fractures / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome; D054854:Vertebroplasty / Q000295:instrumentation* / Q000379:methods
chemical_list: D001843:Bone Cements