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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-11

Study Completion Date

2019-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Fracture Fixation, Internal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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classical pedicle finder

Spinal osteosynthesis with classical pedicle finder

Group Type ACTIVE_COMPARATOR

Spinal osteosynthesis with classical pedicle finder

Intervention Type PROCEDURE

Posterior thoracic and lumbar osteosynthesis with classical pedicle finder

pedicle finder with impedancemetry

Spinal osteosynthesis with pedicle finder with impedancemetry

Group Type EXPERIMENTAL

Spinal osteosynthesis with pedicle finder with impedancemetry

Intervention Type PROCEDURE

Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

Interventions

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Spinal osteosynthesis with classical pedicle finder

Posterior thoracic and lumbar osteosynthesis with classical pedicle finder

Intervention Type PROCEDURE

Spinal osteosynthesis with pedicle finder with impedancemetry

Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No