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Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study

NCT04134975 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-03-11

No results posted yet for this study

Summary

Investigators team propose to evaluate the impact of the use of intraoperative scanning coupled with Stryker navigation, compared to the conventional fluoroscopy technique, on the accuracy of pedicle screws, in instrumented spinal surgery, by a randomised prospective study, in terms of pedicular screw accuracy. We will also evaluate the radiation exposure of the neurosurgical team and the patient in these two techniques.

Conditions

  • Lumbar Disc Disease
  • Surgical Procedure, Unspecified

Interventions

PROCEDURE

Spine surgery

surgery with pedicle screw placement between L1 and S1

Sponsors & Collaborators

  • Ramsay Générale de Santé

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04134975 on ClinicalTrials.gov