Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
1 other identifier
observational
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2016
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2017
CompletedResults Posted
Study results publicly available
September 30, 2019
CompletedMarch 8, 2022
March 1, 2022
11 months
January 2, 2017
July 22, 2019
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification. Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach \< 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach \> 4 mm. Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.
During surgery, mean 6.71 hours
Secondary Outcomes (9)
Procedure Time
During surgery, mean 6.71 hours
Time to Insert Pedicle Screw
Intraoperative, mean 5.18 hours
Length of Hospitalization
From start of the interventional procedure until hospital discharge, approximately 5.3 days
System Usability Score (SUS Score)
End of all surgeries
Patient Radiation Dose
During surgery, mean 6.71 hours
- +4 more secondary outcomes
Study Arms (1)
New image-guidance software
Patients in this group had spine surgery with new image-guidance software application.
Interventions
Patients in this group had spine surgery with new image-guidance software application
Eligibility Criteria
Patients \> 16 years.
You may qualify if:
- Subject undergoing a spine surgery with pedicle screw placement
- Subject 16 years of age or older
- Subject able to give informed consent
You may not qualify if:
- Subject participating in a potentially confounding device or drug trial during the course of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rami Nachabe
- Organization
- Philips
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Elmi-Terander, MD
Karolinska University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 9, 2017
Study Start
November 9, 2016
Primary Completion
October 8, 2017
Study Completion
October 8, 2017
Last Updated
March 8, 2022
Results First Posted
September 30, 2019
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share