Spinal Diseases
Conditions
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.
Interventions
DEVICENew image-guidance software
Patients in this group had spine surgery with new image-guidance software application
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Procedure Time | During surgery, mean 6.71 hours | Time from skin incision to skin closure |
| Radiation Dose (Effective Dose) Received by Operator | During surgery, mean 6.71 hours | — |
| Procedure Related Complications | During surgery, mean 6.71 hours | Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication). |
| Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event | From start of enrollment until hospital discharge, approximately 51 days | — |
| Patient Radiation Dose | During surgery, mean 6.71 hours | Radiation dose measured in Air Kerma (AK) |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Image-guidance Software Patients who had spine surgery with new image-guidance software | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | New Image-guidance Software |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Region of Enrollment Sweden | 21 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
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
Population: 20 subjects were treated with the new image-guidance software. One was treated in the conventional method placing screws by free-hand method.~Total of 253 screws (163 in thoracic, 77 in lumbar and 13 in sacral regions) were placed with new image-guidance software.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Image-guidance Software | Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software | 94.1 Percentage of screw placements |
Secondary
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
Population: 21 patients enrolled, 20 patients treated with new image-guidance software
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| New Image-guidance Software | Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event | Adverse Events (serious and non-serious) | 5 Events |
| New Image-guidance Software | Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event | Adverse Device Effects | 0 Events |
| New Image-guidance Software | Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event | Device deficiencies that could have led to SAE | 0 Events |
Secondary
Length of Hospitalization
Time frame: From start of the interventional procedure until hospital discharge, approximately 5.3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | Length of Hospitalization | 5.3 Days | Standard Deviation 1.71 |
Secondary
Patient Radiation Dose
Radiation dose measured in Dose Area Product (DAP)
Time frame: During surgery, mean 6.71 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | Patient Radiation Dose | 31.26 Gy.cm^2 (DAP) | Standard Deviation 12.604 |
Secondary
Patient Radiation Dose
Radiation dose measured in Air Kerma (AK)
Time frame: During surgery, mean 6.71 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | Patient Radiation Dose | 158.60 mGy (AK) | Standard Deviation 71.014 |
Secondary
Procedure Related Complications
Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).
Time frame: During surgery, mean 6.71 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| New Image-guidance Software | Procedure Related Complications | 3 Procedure related complications |
Secondary
Procedure Time
Time from skin incision to skin closure
Time frame: During surgery, mean 6.71 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | Procedure Time | 6.71 Hours | Standard Deviation 1.69 |
Secondary
Radiation Dose (Effective Dose) Received by Operator
Time frame: During surgery, mean 6.71 hours
Population: There were 2 cases out of the 20 patients were the dosage information was missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | Radiation Dose (Effective Dose) Received by Operator | 0.21 μSv | Standard Deviation 0.261 |
Secondary
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
Population: Four independent physicians provided feedback via a validated system usability score (SUS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | System Usability Score (SUS Score) | 75.6 Scores on a scale | Standard Deviation 13.9 |
Secondary
Time to Insert Pedicle Screw
Time frame: Intraoperative, mean 5.18 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Image-guidance Software | Time to Insert Pedicle Screw | 5.18 Minutes | Standard Deviation 4.03 |