SpineGuard

DSG® Technology

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Scientific Principle

The DSG Technology

The DSG Technology is based on the principle that the electrical conductivity of tissue varies by the type of tissue.

Electrical conductivity is the property of a material to conduct an electrical current:

  • Cortical bone has low conductivity
  • Cancellous bone has medium conductivity
  • Periosteum and blood have high conductivity
This parameter, varying conductivity, allows for differentiation between various tissue types while drilling a pedicle prior to screw placement.

How does the PediGuard probe work?

The PediGuard is a smart drilling single use probe for the preparation of the pilot hole. The DSG technology is at the tip of each PediGuard.

Surgical Technique

Activate

Activate the PediGuard probe by pulling out the paper tab on top of the plastic handle.

Schema of Surgical Technique by Spineguard Step 1

Drill & Listen

Advance the PediGuard probe into the pedicle along the target trajectory for screw placement and pay close attention to the audio feedback provided.

Schema of Surgical Technique by Spineguard Step 2
Schema of Surgical Technique by Spineguard Step 3

Interpret & Redirect

A change in pitch and cadence of the audio feedback indicates a change in the tissue around the tip of the PediGuard probe.

Schema of Surgical Technique by Spineguard Step 4
Schema of Surgical Technique by Spineguard Step 5

Determine Screw Length

Using the graduated markings on the PediGuard probe note the depth to which the probe has been inserted into the pedicle and vertebral body.

Schema of Surgical Technique by Spineguard Step 6

For additional information, please refer to the IFU and surgical technique provided with the PediGuard probes.

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 including in osteoporotic patient (Bocquet 2005, Lubansu 2008, Chang 2009, Chaput 2011, Bai 2012, Heimen 2014, Defino 2015, 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 worldwide.

Publications

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

Contribution of Dynamic Surgical Guidance to the Accurate Placement of Pedicle Screws in Deformity Surgery

1. Allaoui et al, World Neurosurgery (2018 Dec;120:e466-e471. doi: 10.1016/j.wneu.2018.08.105. Epub 2018 Aug 24.) Abstract

Characteristics of deformity surgery in patients with severe and rigid cervical kyphosis (CK): results of the CSRS-Europe multi-centre study project

2. Koller et al, European Spine Journal (2018 Nov 27. doi: 10.1007/s00586-018-5835-2.) Abstract

Osteotomies in ankylosing spondylitis: where, how many and how much?

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.)10.1007/s00586-018-5835-2.) Abstract

Accuracy of a dynamic surgical guidance probe for screw insertion in the cervical spine: a cadaveric study

4. Dixon et al, Eur Spine J. (2017 April 26) Abstract

Control of Pedicle Screw Placement with an Electrical Conductivity Measurement Device: Initial Evaluation in the Thoracic and Lumbar Spine

5. Suess O al. Adv Med. (2016:4296294. Epub 2016 Sep 6.) Abstract

S2-AI screw placement with the aid of electronic conductivity device monitoring: a retrospective analysis

6. Sandhu et al, European Spine Journal (Apr;26(4):1149-1153. doi: 10.1007/s00586-016-4840-6. Epub 2016 Nov 14.) Abstract

Anticipation of vertebral pedicle breach through dynamic surgical guidance

7. Williams et al, Coluna Columna (2014: 210-213.) Full text

Independent assessment of a new pedicle probe and its ability to detect pedicle breach: a cadaveric study

8. Guillen et al, Journal of Neurosurgery Spine (2014 Nov; 21(5):821-5) Full text

Comparison of the Pedicle Screws Placement Between Electronic Conductivity Device and Normal Pedicle Finder in Posterior Surgery of Scoliosis

9. Bai et al, Journal of Spinal Disorders & Techniques (2013 Aug;26(6):316-20.) Abstract

Reduction in Radiation (Fluoroscopy) While Maintaining Safe Placement of Pedicle Screws During Lumbar Spine Fusion

10.Chaput et al, Coluna/Columna (2013, vol.12, no.2, p.138-141. ISSN 1808-1851) Abstract

Reduction in Radiation (Fluoroscopy) While Maintaining Safe Placement of Pedicle Screws During Lumbar Spine Fusion 2

11. Chaput et al, SPINE (2012 Oct 1;37(21):E1305-9.) Abstract

The Contribution of an Electronic Conductivity Device to the Safety of Pedicle Screw Insertion in Scoliosis Surgery

12. Ovadia et al, SPINE (2011 Sep 15;36(20):E1314-21) Abstract

Electrical conductivity measurement: a new technique to detect iatrogenic initial pedicle perforation

13.Bolger et al, European Spine Journal (2007 Nov;16(11):1919-24. Epub 2007 Jun 30.) Full text

A preliminary study of reliability of impedance measurement to detect iatrogenic initial pedicle perforation (in the porcine model)

14. Bolger et al, European Spine Journal (October 2005, Volume 15, Issue 3, pp 316 – 320) Abstract

Presentations

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

Does The Use Of Dynamic Surgical Guidance Assist With Accurate Pedicle Screw Placement In Patients With Osteoporosis Or Osteopenia?

1.Defino et al. 2015. 15e Congresso Brasileiro de Coluna. SpineWeek, 2016. Singapore.

Analysis of Cervical Screw Placement Accuracy and Fixation in 137 Patients with Focus on Patients with Cervical Deformity using an Electrical Conductivity Device (ECD)

2. Koller et al, CSRS-NA Annual Scientific Meeting Poster (December 2014).

Prospektive Untersuchung der Schraubenpositionierung bei Spondylodesen zwischen Bildwandler gesteuerter (Standard) und Schraubenplatzierung mittels induktivem Pfriem.

3. Heimen et al. J. DWG annual meeting. Congress Center Leizpig, Leizpig, Germany. 11-13 Dec. 2014. Oral presentation:

Prospective Evaluation of a Free-Hand Electrical Conductivity Measuring Device to Reduce Radiation Exposure during Fluoroscopically Assisted Open or Minimally Invasive Pedicle Screw Arthrodesis

4. Lubansu et al, Eurospine Annual Scientific Meeting Poster (October 2011)

Clinical application of a specialized hand held pedicle drilling tool for pedicle screw placement in thoraco-lumbar fusions

5. Chang et al, AANS Annual Scientific Meeting Poster (2009)

Prospective evaluation of the interest of a free-hand electrical conductivity measuring device to reduce radiation exposure during fluoroscopically assisted pedicle screw fixation

6. Lubansu et al, SFCR Annual Scientific Meeting Poster (2008)

Pedicle screw placement in spinal surgery at lumbar level: interest of guidance by conductivity measurement in the placement of 104 pedicle screws

7. Bocquet, Eurospine Annual Scientific Meeting Poster (October 2006)

The Use of an Electrical Conductivity-Monitoring Device (ECMD) Shortens the Learning Curve for Accurate Placement of Pedicle Screws: A Cadaveric Study

8. Syed, et al, CNS annual meeting (2014) and SRS annual meeting (2015)

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