[Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures]

Z Orthop Unfall. 2012 Dec;150(6):572-8. doi: 10.1055/s-0032-1327935. Epub 2013 Jan 7.
[Article in German]

Abstract

Background: As a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated.

Material and 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.

Conclusion: On the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.

Publication types

  • Clinical Trial
  • English Abstract

MeSH terms

  • Aged
  • Bone Cements / therapeutic use*
  • Equipment Failure Analysis
  • Female
  • Fractures, Compression / complications
  • Fractures, Compression / therapy*
  • Humans
  • Internal Fixators*
  • Male
  • Pain / etiology
  • Pain / prevention & control*
  • Pilot Projects
  • Prosthesis Design
  • Spinal Fractures / complications
  • Spinal Fractures / therapy*
  • Treatment Outcome
  • Vertebroplasty / instrumentation*
  • Vertebroplasty / methods

Substances

  • Bone Cements