Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions

NCT ID: NCT03015142

Last Updated: 2022-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-09

Study Completion Date

2017-10-08

Brief Summary

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There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries). The objective of the study was to investigate the accuracy of screw placement during spine surgery.

Detailed Description

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Conditions

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Spinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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New image-guidance software

Patients in this group had spine surgery with new image-guidance software application.

New image-guidance software

Intervention Type DEVICE

Patients in this group had spine surgery with new image-guidance software application

Interventions

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New image-guidance software

Patients in this group had spine surgery with new image-guidance software application

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject undergoing a spine surgery with pedicle screw placement
* Subject 16 years of age or older
* Subject able to give informed consent

Exclusion Criteria

* Subject participating in a potentially confounding device or drug trial during the course of the study.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Elmi-Terander, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://journals.lww.com/spinejournal/Abstract/publishahead/Pedicle_Screw_Placement_Using_Augmented_Reality.94855.aspx

Pedicle Screw Placement Using Augmented Reality Surgical Navigation with Intraoperative 3D Imaging. A First In-Human Prospective Cohort Study.

Other Identifiers

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XCY607-130099

Identifier Type: -

Identifier Source: org_study_id

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