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

NCT02826499 | Completed

• 1 other identifier: CHUB-Pediguard
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pedicular Screwing

Keywords

Pediguard; Pedicular screws; Fluoroscopy

Outcome Measures

Primary Outcomes (2)

• Pedicular effraction grade

  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).

  Between 24 and 48h after surgery

• Pedicular effraction grade

  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).

  1 year after surgery

Secondary Outcomes (4)

• Oswestry Disability Index (ODI)

  Baseline

• Oswestry Disability Index (ODI)

  1 year after surgery

• SF-36 questionnaire

  Baseline

• SF-36 questionnaire

  1 year after surgery

Study Arms (2)

Fluoroscopy

ACTIVE COMPARATOR

Vertebral instrumentation with pedicular screwing, performed under fluoroscopy.

Other: Fluoroscopy

Fluoroscopy and Pediguard

EXPERIMENTAL

Vertebral instrumentation with pedicular screwing, performed under fluoroscopy, with the Pediguard system.

Device: Pediguard; Other: Fluoroscopy

Interventions

Pediguard DEVICE

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.

Fluoroscopy and Pediguard

Fluoroscopy OTHER

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.

Fluoroscopy; Fluoroscopy and Pediguard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients needing vertebral instrumentation with pedicular screwing

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Study Officials

• Tamas Illes, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

BE (1)