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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02826499
Enrollment
20
Registered
2016-07-11
Start date
2016-07-31
Completion date
2017-07-31
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pedicular Screwing

Keywords

Pediguard, Pedicular screws, Fluoroscopy

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.

Interventions

DEVICEPediguard

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.

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.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients needing vertebral instrumentation with pedicular screwing

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pedicular effraction gradeBetween 24 and 48h after surgeryEvaluation 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

MeasureTime frameDescription
Oswestry Disability Index (ODI)BaselineClinical functional scoring, assessed before the surgical intervention.
SF-36 questionnaireBaselineQuality of life evaluation, assessed before the surgical intervention.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026