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

Philips Clinical & Medical Affairs Global21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Diseases

Interventions

New image-guidance softwareDEVICE

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (1)

Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: During surgery, mean 6.71 hours

Secondary Outcomes

Procedure Time

Time from skin incision to skin closure

Time frame: During surgery, mean 6.71 hours

Time to Insert Pedicle Screw

Time frame: Intraoperative, mean 5.18 hours

Length of Hospitalization

Time frame: From start of the interventional procedure until hospital discharge, approximately 5.3 days

System Usability Score (SUS Score)

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).

Time frame: End of all surgeries

Patient Radiation Dose

Radiation dose measured in Air Kerma (AK)

Time frame: During surgery, mean 6.71 hours

Patient Radiation Dose

Radiation dose measured in Dose Area Product (DAP)

Time frame: During surgery, mean 6.71 hours

Data from ClinicalTrials.gov

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