Clinical Data


CLINICAL RESEARCH VALIDATES PEDIGUARD® PROBES

With mounting clinical evidence confirming its efficacy, PediGuard devices, that integrate the DSG™ Technology, are becoming a compelling answer to the clinical needs associated with safe and accurate pedicle screw placement.

  • 97% screw placement accuracy (Defino 2015, Heimen 2014, Bai 2013, Chaput 2012, Chang 2009, Bocquet 2006.)
  • 98% breach detection (Bolger 2007)
  • 100% pedicle breach anticipation and 87% breach anticipation overall (Williams 2014)
  • 58% breach rate reduction when used by residents (Sandhu 2014)
  • 3-times fewer pedicle perforations than with free-hand technique (Bai 2013)
  • 3-fold reduction in neuro-monitoring alarms (Ovadia 2011)
  • 25% – 54% reduction in radiation exposure during pedicle screw placement (Chaput 2012, Bai 2013, Defino 2015)
  • 15% surgical time savings during screw placement (Bai 2013)

PediGuard probes, that integrate the DSG™ Technology, have assisted spine surgeons in accurately placing over 300,000 pedicle screws woldwilde.

 

Publications: The following articles published in reputed peer-reviewed journals validate the accuracy and benefits of the PediGuard Probes and DSG Technology:

  1. Dixon et al, Eur Spine J. (2017 April 26)
    Accuracy of a dynamic surgical guidance probe for screw insertion in the cervical spine: a cadaveric study (abstract)
  2. Suess O al. Adv Med. (2016: 4296294. Epub 2016 Sep 6.)
    Control of Pedicle Screw Placement with an Electrical Conductivity Measurement Device: Initial Evaluation in the Thoracic and Lumbar Spine (abstract)
  3. Chaput et al, SPINE (2012 Oct 1;37(21):E1305-9.)
    Reduction in Radiation (Fluoroscopy) While Maintaining Safe Placement of Pedicle Screws During Lumbar Spine Fusion (abstract)
  4. Bai et al, Journal of Spinal Disorders & Techniques (2013 Aug;26(6):316-20.)
    Comparison of the Pedicle Screws Placement Between Electronic Conductivity Device and Normal Pedicle Finder in Posterior Surgery of Scoliosis (abstract)
  5. Ovadia et al, SPINE (2011 Sep 15;36(20):E1314-21)
    The Contribution of an Electronic Conductivity Device to the Safety of Pedicle Screw Insertion in Scoliosis Surgery (abstract)
  6. Bolger et al, European Spine Journal (2007 Nov;16(11):1919-24. Epub 2007 Jun 30.)
    Electrical conductivity measurement: a new technique to detect iatrogenic initial pedicle perforation (Full text)
  7. Guillen et al, Journal of Neurosurgery Spine (2014 Nov;21(5):821-5)
    Independent assessment of a new pedicle probe and its ability to detect pedicle breach:  a cadaveric study (Full text)
  8. Williams et al, Coluna Columna (2014: 210-213.)
    Anticipation of vertebral pedicle breach through dynamic surgical guidance (Full text)

Presentations: Data from the clinical research of the PediGuard probes was presented at the following scientific/clinical society meetings:

  1. Defino et al. 2015. 15e Congresso Brasileiro de Coluna. SpineWeek, 2016. Singapore. Does The Use Of Dynamic Surgical Guidance Assist With Accurate Pedicle Screw Placement In Patients With Osteoporosis Or Osteopenia?
  2. Koller et al, CSRS-NA Annual Scientific Meeting Poster (December 2014).  Analysis of Cervical Screw Placement Accuracy and Fixation in 137 Patients with Focus on Patients with Cervical Deformity using an Electrical Conductivity Device (ECD)
  3. Heimen et al. J. DWG annual meeting. Congress Center Leizpig, Leizpig, Germany. 11-13 Dec. 2014. Oral presentation: Prospektive Untersuchung der Schraubenpositionierung bei Spondylodesen zwischen Bildwandler gesteuerter (Standard) und Schraubenplatzierung mittels induktivem Pfriem.
  4. Lubansu et al, Eurospine Annual Scientific Meeting Poster (October 2011)
    Prospective Evaluation of a Free-Hand Electrical Conductivity Measuring Device to Reduce Radiation Exposure during Fluoroscopically Assisted Open or Minimally Invasive Pedicle Screw Arthrodesis
  5. Chang et al, AANS Annual Scientific Meeting Poster (2009)
    Clinical application of a specialized hand held pedicle drilling tool for pedicle screw placement in thoraco-lumbar fusions
  6. Lubansu et al, SFCR Annual Scientific Meeting Poster (2008)
    Prospective evaluation of the interest of a free-hand electrical conductivity measuring device to reduce radiation exposure during fluoroscopically assisted pedicle screw fixation
  7. Bocquet, Eurospine Annual Scientific Meeting Poster (October 2006)
    Pedicle screw placement in spinal surgery at lumbar level:  interest of guidance by conductivity measurement in the placement of 104 pedicle screws

Please contact SpineGuard to request a copy of the most up-to-date version of the comprehensive Clinical Brochure, which summarizes these studies and identifies the clinical benefits and overall value of the PediGuard Probes and DSG Technology