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Comparison of the Malposition Rates of the Vertebral Pedicle Screws Using the PediGuard Technique: PediGuard Technique Associated With Fluoroscopy and Fluoroscopy Alone

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ClinicalTrials.gov Identifier: NCT02826499
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Tamas Illes, Brugmann University Hospital

Brief Summary:

Pedicular screwing has become the gold standard for intervertebral fixation required in degenerative, scoliotic, tumoral pathologies or for fractures. Several pedicular screwing methods exist.

The free hand pedicular screwing requires a high learning curve and has, as a consequence, a high malposition rate.

The placing of pedicular screws under fluoroscopic control is the most common technique as it is both reproducible and accessible. It is a two dimensional imaging technique. The profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and the direction of the screw in the sagittal plane. However, there is no real control of the direction of the pedicular screw in the horizontal or frontal plane. The screw malposition rate is less important than with the 'free hand' technique but remains none of the less significant. Furthermore, fluoroscopy is an irradiating imaging technique, both for the patient and the staff.

New revolutionary techniques as the tridimensional navigation and the per-operatory tomodensitometry appeared in the last few years. The techniques give the best results when used concommitantly. The material has the advantage of being very precise. The pedicular screw malposition rate is minimal after a three-dimensional localisation. However, those systems require qualified staff and expose the patient and the nursing team to high radiation levels. The costs are higher and the surgery duration is globally longer. It is thus difficult to implement this technique in each belgian hospital.

Finally, the Pediguard technique appeared on the market. It is a guide for the perforation of the pedicular channel, with a probe at its extremity. This probe allows a real time measurement of the electric conductivity of the tissues that are being crossed. The conductivity measure is translated in a sound signal. Because the cortical bone has a low conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the event of a breach in the pedicular cortical, as blood and periost have a high conductibility, the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to anticipate a cortical effraction, by detecting the proximity of the cortical wall. It is efficient but remains relatively expensive.

The main objective of this study is to determine the precision of the placing of pedicular screws, with and without Pediguard system, under fluoroscopy.


Condition or disease Intervention/treatment Phase
Pedicular Screwing Device: Pediguard Other: Fluoroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Malposition Rates of the Vertebral Pedicle Screws Using the PediGuard Technique: PediGuard Technique Associated With Fluoroscopy and Fluoroscopy Alone
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Active Comparator: Fluoroscopy
Vertebral instrumentation with pedicular screwing, performed under fluoroscopy.
Other: Fluoroscopy
The placing of pedicular screws under fluoroscopic control is the most common technique as it is both reproducible and accessible. It is a two dimensional imaging technique. The profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and the direction of the screw in the sagittal plane. However, there is no real control of the direction of the pedicular screw in the horizontal or frontal plane and it is an irradiating imaging technique.

Experimental: Fluoroscopy and Pediguard
Vertebral instrumentation with pedicular screwing, performed under fluoroscopy, with the Pediguard system.
Device: Pediguard
It is a guide for the perforation of the pedicular channel, with a probe at its extremity. This probe allows a real time measurement of the electric conductivity of the tissues that are being crossed. The conductivity measure is translated in a sound signal. Because the cortical bone has a low conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the event of a breach in the pedicular cortical, as blood and periost have a high conductibility, the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to anticipate a cortical effraction, by detecting the proximity of the cortical wall.

Other: Fluoroscopy
The placing of pedicular screws under fluoroscopic control is the most common technique as it is both reproducible and accessible. It is a two dimensional imaging technique. The profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and the direction of the screw in the sagittal plane. However, there is no real control of the direction of the pedicular screw in the horizontal or frontal plane and it is an irradiating imaging technique.




Primary Outcome Measures :
  1. Pedicular effraction grade [ Time Frame: Between 24 and 48h after surgery ]
    Evaluation of screw malposition, performed under CT-scan and graded according to the following: 0 (no effraction), grade 1 (effraction up to 2 mm), grade 2 (effraction between 2 and 4 mm), grade 3 (effraction of more than 4 mm).

  2. Pedicular effraction grade [ Time Frame: 1 year after surgery ]
    Evaluation of screw malposition, performed under CT-scan and graded according to the following: 0 (no effraction), grade 1 (effraction up to 2 mm), grade 2 (effraction between 2 and 4 mm), grade 3 (effraction of more than 4 mm).


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline ]
    Clinical functional scoring, assessed before the surgical intervention.

  2. Oswestry Disability Index (ODI) [ Time Frame: 1 year after surgery ]
    Clinical functional scoring

  3. SF-36 questionnaire [ Time Frame: Baseline ]
    Quality of life evaluation, assessed before the surgical intervention.

  4. SF-36 questionnaire [ Time Frame: 1 year after surgery ]
    Quality of life evaluation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients needing vertebral instrumentation with pedicular screwing

Exclusion Criteria:

  • Contra-indication to the placement of pedicular screws under fluoroscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826499


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Tamas Illes, MD CHU Brugmann

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Responsible Party: Tamas Illes, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02826499     History of Changes
Other Study ID Numbers: CHUB-Pediguard
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Tamas Illes, Brugmann University Hospital:
Pediguard
Pedicular screws
Fluoroscopy