Clinical Data


CLINICAL RESEARCH VALIDATES PEDIGUARD® PROBES IN

SPINE SURGERY

14 Major Peer-Reviewed Publications

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.

Screw placement accuracy and breach detection

  • 97% screw placement accuracy (Bocquet 2005, Lubansu 2008, Chang 2009, Chaput 2011, Bai 2012, Suess 2016)
  • 98% breach detection, twice better than conventional technique (Bolger 2007)
  • 100% medial pedicle breach anticipation (Williams 2014)
  • 92.5% complex deformity, accuracy upper thoracic (Allaoui 2018)
  • 3-times less neuro-monitoring alarms (Ovadia 2011)

Radiation safety and surgical efficiency

  • 73% reduction of X-Ray time in MIS (Lubansu 2011)
  • 30% reduction of X-Ray shots in open surgery (Chaput 2011, Bai 2012)
  • 15% surgical time savings during screw placement (Bai 2012)

Surgical education

  • 58% breach rate reduction among residents (Syed 2014)

New applications and techniques

  • 91% cervical spine lateral mass and pedicle screw placement accuracy (Darden 2016, Koller 2018)
  • New technique with Sacro-Iliac fusion (Sandhu 2014)

PediGuard probes, that integrate the DSG® Technology, have assisted spine surgeons in accurately placing over 330,000 pedicle screws woldwide.

Publications

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

  1. Allaoui et al, World Neurosurgery (2018 Dec;120:e466-e471. doi: 10.1016/j.wneu.2018.08.105. Epub 2018 Aug 24.)
    Contribution of Dynamic Surgical Guidance to the Accurate Placement of Pedicle Screws in Deformity Surgery (abstract)
  2. Koller et al, European Spine Journal (2018 Nov 27. doi: 10.1007/s00586-018-5835-2.)
    Characteristics of deformity surgery in patients with severe and rigid cervical kyphosis (CK): results of the CSRS-Europe multi-centre study project (abstract)
  3. Koller et al, European Spine Journal (2018 Feb;27(Suppl 1):70-100. doi: 10.1007/s00586-017-5421-z. Epub 2017 Dec 30.)
    Osteotomies in ankylosing spondylitis: where, how many and how much? (abstract)
  4. 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)
  5. 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)
  6. Sandhu et al, European Spine Journal (Apr;26(4):1149-1153. doi: 10.1007/s00586-016-4840-6. Epub 2016 Nov 14.)
    S2-AI screw placement with the aide of electronic conductivity device monitoring: a retrospective analysis (abstract)
  7. Williams et al, Coluna Columna (2014: 210-213.)
    Anticipation of vertebral pedicle breach through dynamic surgical guidance (Full text)
  8. 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)
  9. 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)
  10. Chaput et al, Coluna/Columna (2013, vol.12, no.2, p.138-141. ISSN 1808-1851)
    Reduction in Radiation (Fluoroscopy) While Maintaining Safe Placement of Pedicle Screws During Lumbar Spine Fusion (abstract)
  11. 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)
  12. 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)
  13. 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)
  14. Bolger et al, European Spine Journal (October 2005, Volume 15, Issue 3, pp 316 – 320)
    A preliminary study of reliability of impedance measurement to detect iatrogenic initial pedicle perforation (in the porcine model) (abstract)

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
  8. Syed, et al, CNS annual meeting (2014) and SRS annual meeting (2015)
    The Use of an Electrical Conductivity-Monitoring Device (ECMD) Shortens the Learning Curve for Accurate Placement of Pedicle Screws: A Cadaveric Study

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