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Completed

NCT Number: NCT03238521

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

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.

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Key information

Conditions

Fracture Fixation, Internal

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic surgery division

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal osteosynthesis with classical pedicle finder

Procedure

Posterior thoracic and lumbar osteosynthesis with classical pedicle finder

Spinal osteosynthesis with pedicle finder with impedancemetry

Procedure

Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

Primary outcomes

  1. Dose area product in cGy.cm2 (DAP)

    Time frame: Surgery Day

    Dose area product in cGy.cm2 (DAP)

Secondary outcomes

  1. Radiation duration in seconds (measured on the fluoroscope);

    Time frame: Surgery Day

    Radiation duration in seconds (measured on the fluoroscope);

  2. 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

  3. Path of pedicle screws extracted from fluoroscopic images

    Time frame: Day 2 after surgery

    Trajectory of pedicle screws;

  4. Operating time in minutes.

    Time frame: Surgery Day

    Operating time in minutes.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: PEDI-PDS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2017
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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