RAVINE

• Research type

  Research Study

• Full title

  A Comparison of Complication Rates between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System versus NuVasive XLIF® - Post market surveillance study

• IRAS ID

  182282

• Contact name

  Robert Lee

• Sponsor organisation

  K2M, Inc.

• Duration of Study in the UK

  2 years, 10 months, 17 days

• Research summary

  Degenerative disc disease is a spinal condition caused by the breakdown of intervertebral discs, this is a painful condition, which usually requires surgical treatment, which leads to spinal fusion as a result of which the pain caused should be minimised. The surgical approach and type of device used can minimise the muscle disruption and blood loss and such lead to faster recovery. Various devices are currently available on the market and are used in everyday practice. The aim of this study is to collect data from patients being treated with a specific device (K2M RAVINE system) during lateral spine surgery. The data collected will be compared to data already available in literature on a different device (NuVasive XLIF® system). Particular focus will be looking at the incidence of thigh/leg pain and dysesthesia (abnormal sensation). This will be assessed from radiological outcomes and from questionnaires completed by patients reporting their outcome and their pain.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  15/WM/0366

• Date of REC Opinion

  23 Nov 2015

• REC opinion

  Further Information Favourable Opinion