An observational study in Spinal Diseases, sponsored by Philips Clinical & Medical Affairs Global. Completed at 1 site in Sweden. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Philips Clinical & Medical Affairs Global · Observational
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.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's enrollment of 21 is below the median of 108 across 87 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Philips Clinical & Medical Affairs Global is the lead sponsor of 82 studies on the registry; 24 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients > 16 years.
Exclusion Criteria:
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
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
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
Radiation Dose (Effective Dose) Received by Operator
Time frame: During surgery, mean 6.71 hours
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
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
| Milestone | New Image-guidance Software |
|---|---|
| Started | 21 |
| Completed | 20 |
| Not completed | 1 |
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.
| Percentage of screw placements | New Image-guidance Software |
|---|---|
| Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software | 94.1 (90.4 to 96.6) |
Time from skin incision to skin closure
| Hours | New Image-guidance Software |
|---|---|
| Procedure Time | 6.71 ± 1.69 |
| Minutes | New Image-guidance Software |
|---|---|
| Time to Insert Pedicle Screw | 5.18 ± 4.03 |
| Days | New Image-guidance Software |
|---|---|
| Length of Hospitalization | 5.3 ± 1.71 |
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).
| Scores on a scale | New Image-guidance Software |
|---|---|
| System Usability Score (SUS Score) | 75.6 ± 13.9 |
Radiation dose measured in Air Kerma (AK)
| mGy (AK) | New Image-guidance Software |
|---|---|
| Patient Radiation Dose | 158.60 ± 71.014 |
Radiation dose measured in Dose Area Product (DAP)
| Gy.cm^2 (DAP) | New Image-guidance Software |
|---|---|
| Patient Radiation Dose | 31.26 ± 12.604 |
| μSv | New Image-guidance Software |
|---|---|
| Radiation Dose (Effective Dose) Received by Operator | 0.21 ± 0.261 |
Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).
| Procedure related complications | New Image-guidance Software |
|---|---|
| Procedure Related Complications | 3 |
| Events | New Image-guidance Software |
|---|---|
| Adverse Events (serious and non-serious) | 5 |
| Adverse Device Effects | 0 |
| Device deficiencies that could have led to SAE | 0 |
Collected over From start of enrollment until hospital discharge, approximately 51 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| New Image-guidance Software | 0/20 (0%) | 1/20 (5%) | 4/20 (20%) |
| Event | New Image-guidance Software |
|---|---|
| Pain right leg due to foramina stenosis by L5 screw. Screw was placed by free-hand.Surgical and medical procedures | 1/20 |
| Event | New Image-guidance Software |
|---|---|
| Horner's syndromeSurgical and medical procedures | 1/20 |
| Postoperative painSurgical and medical procedures | 1/20 |
| Repeated Xper-CTSurgical and medical procedures | 1/20 |
| UrticariaSurgical and medical procedures | 1/20 |
| Age, Categorical(Participants) | New Image-guidance Software |
|---|---|
| <=18 years | 10 |
| Between 18 and 65 years | 9 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | New Image-guidance Software |
|---|---|
| Female | 12 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | New Image-guidance Software |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 21 |
| Region of Enrollment(participants) | New Image-guidance Software |
|---|---|
| Sweden | 21 |
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Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Philips Clinical & Medical Affairs Global