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

August 28, 2018 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: classical pedicle finder
Spinal osteosynthesis with classical pedicle finder
Procedure: Spinal osteosynthesis with classical pedicle finder
Posterior thoracic and lumbar osteosynthesis with classical pedicle finder
Experimental: pedicle finder with impedancemetry
Spinal osteosynthesis with pedicle finder with impedancemetry
Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry
Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose area product in cGy.cm2 (DAP)
Time Frame: Surgery Day
Dose area product in cGy.cm2 (DAP)
Surgery Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation duration in seconds (measured on the fluoroscope);
Time Frame: Surgery Day
Radiation duration in seconds (measured on the fluoroscope);
Surgery Day
Radiation rate
Time Frame: 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
Surgery Day
Path of pedicle screws extracted from fluoroscopic images
Time Frame: Day 2 after surgery
Trajectory of pedicle screws;
Day 2 after surgery
Operating time in minutes.
Time Frame: Surgery Day
Operating time in minutes.
Surgery Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Jonathan LEBHAR, MD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2017

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC16_9855_PEDI-PDS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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