Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device?

Not Applicable

• Conditions: Fracture Fixation, Internal
• Interventions: Procedure: Spinal osteosynthesis with classical pedicle finder; Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry

• Registration Number: NCT03238521
• Lead Sponsor: Rennes University Hospital

Brief Summary

To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Study Start: 2017-11-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Men and women between 18 and 80 years-old;
• Patient with an indication of PPTLO for one or two segments
• Patient in a position to understand protocol information;
• Patient who received information about the protocol and who did not show opposition to participate

Exclusion Criteria

• History of posterior spinal fusion surgery on the spinal level concerned by the study;
• Morbid obesity (body mass index greater than 35 kg / m²);
• Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.
• Simultaneous participation in another research protocol involving the human person

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
classical pedicle finder	Spinal osteosynthesis with classical pedicle finder	Spinal osteosynthesis with classical pedicle finder
pedicle finder with impedancemetry	Spinal osteosynthesis with pedicle finder with impedancemetry	Spinal osteosynthesis with pedicle finder with impedancemetry

Primary Outcome Measures

Name	Time	Method
Dose area product in cGy.cm2 (DAP)	Surgery Day	Dose area product in cGy.cm2 (DAP)

Secondary Outcome Measures

Name	Time	Method
Operating time in minutes.	Surgery Day	Operating time in minutes.
Radiation duration in seconds (measured on the fluoroscope);	Surgery Day	Radiation duration in seconds (measured on the fluoroscope);
Radiation rate	Surgery Day	Radiation rate on:1 ring carried by the surgeon (passive dosimeter),1 passive dosimeter worn at the surgeon's eye level, 1 passive dosimeter on the fluoroscope,1 active dosimeter placed on the bust of the surgeon under the lead apron
Path of pedicle screws extracted from fluoroscopic images	Day 2 after surgery	Trajectory of pedicle screws;

Trial Locations

Locations (1)

Orthopedic surgery division; 🇫🇷 Rennes, France