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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03238521

Acronym

PEDI-PDS

Enrollment

Registered

2017-08-03

Start date

2017-11-11

Completion date

2019-09-02

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Fixation, Internal

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.

Interventions

PROCEDURESpinal osteosynthesis with classical pedicle finder

Posterior thoracic and lumbar osteosynthesis with classical pedicle finder

PROCEDURESpinal osteosynthesis with pedicle finder with impedancemetry

Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Dose area product in cGy.cm2 (DAP)	Surgery Day	Dose area product in cGy.cm2 (DAP)

Secondary

Measure	Time frame	Description
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;
Operating time in minutes.	Surgery Day	Operating time in minutes.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJonathan LEBHAR, MD

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026