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Completed

NCT Number: NCT03015142

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

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.

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Key information

Conditions

Spinal Diseases Bone Diseases Musculoskeletal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

New image-guidance software

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2017
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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