Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015142
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

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.

Condition or disease Intervention/treatment
Spinal Diseases Device: New image-guidance software

Layout table for study information
Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
Actual Study Start Date : November 9, 2016
Actual Primary Completion Date : October 8, 2017
Actual Study Completion Date : October 8, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
New image-guidance software
Patients in this group had spine surgery with new image-guidance software application.
Device: New image-guidance software
Patients in this group had spine surgery with new image-guidance software application




Primary Outcome Measures :
  1. Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software [ Time Frame: During surgery, mean 6.71 hours ]

    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.



Secondary Outcome Measures :
  1. Procedure Time [ Time Frame: During surgery, mean 6.71 hours ]
    Time from skin incision to skin closure

  2. Time to Insert Pedicle Screw [ Time Frame: Intraoperative, mean 5.18 hours ]
  3. Length of Hospitalization [ Time Frame: From start of the interventional procedure until hospital discharge, approximately 5.3 days ]
  4. System Usability Score (SUS Score) [ Time Frame: End of all surgeries ]
    The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).

  5. Patient Radiation Dose [ Time Frame: During surgery, mean 6.71 hours ]
    Radiation dose measured in Air Kerma (AK)

  6. Patient Radiation Dose [ Time Frame: During surgery, mean 6.71 hours ]
    Radiation dose measured in Dose Area Product (DAP)

  7. Radiation Dose (Effective Dose) Received by Operator [ Time Frame: During surgery, mean 6.71 hours ]
  8. Procedure Related Complications [ Time Frame: During surgery, mean 6.71 hours ]
    Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).

  9. Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event [ Time Frame: From start of enrollment until hospital discharge, approximately 51 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients > 16 years.
Criteria

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.
  • Subject meeting an exclusion criteria according to national law (e.g. pregnant woman, breast feeding woman)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015142


Locations
Layout table for location information
Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Philips Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Adrian Elmi-Terander, MD Karolinska University Hospital
  Study Documents (Full-Text)

Documents provided by Philips Healthcare:
Statistical Analysis Plan  [PDF] May 31, 2018
Study Protocol  [PDF] October 4, 2016

Layout table for additonal information
Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT03015142    
Other Study ID Numbers: XCY607-130099
First Posted: January 9, 2017    Key Record Dates
Results First Posted: September 30, 2019
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases