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

Fracture Fixation, Internal Clinical Trial

— PEDI-PDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238521
• Other study ID #: 35RC16_9855_PEDI-PDS
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2017
• Est. completion date: May 2019

Study information

• Verified date: August 2018
• Source: Rennes University Hospital
• Contact: Jonathan LEBHAR, MD
• Phone: 299285753
• Email: Jonathan.LEBHAR[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture Fixation, Internal

Intervention

Procedure:
• Spinal osteosynthesis with classical pedicle finder
Posterior thoracic and lumbar osteosynthesis with classical pedicle finder
• Spinal osteosynthesis with pedicle finder with impedancemetry
Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

Locations

Country	Name	City	State
France	Orthopedic surgery division	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose area product in cGy.cm2 (DAP)	Dose area product in cGy.cm2 (DAP)	Surgery Day
Secondary	Radiation duration in seconds (measured on the fluoroscope);	Radiation duration in seconds (measured on the fluoroscope);	Surgery Day
Secondary	Radiation rate	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	Surgery Day
Secondary	Path of pedicle screws extracted from fluoroscopic images	Trajectory of pedicle screws;	Day 2 after surgery
Secondary	Operating time in minutes.	Operating time in minutes.	Surgery Day