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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New image-guidance software | Patients in this group had spine surgery with new image-guidance software application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New image-guidance software | Device | Patients in this group had spine surgery with new image-guidance software application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During surgery, mean 6.71 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Time from skin incision to skin closure | During surgery, mean 6.71 hours |
| Time to Insert Pedicle Screw | Intraoperative, mean 5.18 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients > 16 years.
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Elmi-Terander, MD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
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| Label | URL |
|---|---|
| Pedicle Screw Placement Using Augmented Reality Surgical Navigation with Intraoperative 3D Imaging. A First In-Human Prospective Cohort Study. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Image-guidance Software | Patients who had spine surgery with new image-guidance software. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Image-guidance Software | Patients who had spine surgery with new image-guidance software |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of screw placements | During surgery, mean 6.71 hours | Screw placements | Screw placements |
|
From start of enrollment until hospital discharge, approximately 51 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Image-guidance Software | Patients who had spine surgery with new image-guidance software |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain right leg due to foramina stenosis by L5 screw. Screw was placed by free-hand. | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Horner's syndrome | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rami Nachabe | Philips | +1-513-926-1486 | rami.nachabe@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2016 | Jul 22, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2018 | Jul 22, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Length of Hospitalization | 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). | End of all surgeries |
| Patient Radiation Dose | Radiation dose measured in Air Kerma (AK) | During surgery, mean 6.71 hours |
| Patient Radiation Dose | Radiation dose measured in Dose Area Product (DAP) | During surgery, mean 6.71 hours |
| Radiation Dose (Effective Dose) Received by Operator | During surgery, mean 6.71 hours |
| Procedure Related Complications | Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication). | During surgery, mean 6.71 hours |
| 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 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients who had spine surgery with new image-guidance software |
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| Secondary | Procedure Time | Time from skin incision to skin closure | Posted | Mean | Standard Deviation | Hours | During surgery, mean 6.71 hours |
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| Secondary | Time to Insert Pedicle Screw | Posted | Mean | Standard Deviation | Minutes | Intraoperative, mean 5.18 hours |
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| Secondary | Length of Hospitalization | Posted | Mean | Standard Deviation | Days | From start of the interventional procedure until hospital discharge, approximately 5.3 days |
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| 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). | Four independent physicians provided feedback via a validated system usability score (SUS) | Posted | Mean | Standard Deviation | Scores on a scale | End of all surgeries |
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| Secondary | Patient Radiation Dose | Radiation dose measured in Air Kerma (AK) | Posted | Mean | Standard Deviation | mGy (AK) | During surgery, mean 6.71 hours |
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| Secondary | Patient Radiation Dose | Radiation dose measured in Dose Area Product (DAP) | Posted | Mean | Standard Deviation | Gy.cm^2 (DAP) | During surgery, mean 6.71 hours |
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| Secondary | Radiation Dose (Effective Dose) Received by Operator | There were 2 cases out of the 20 patients were the dosage information was missing. | Posted | Mean | Standard Deviation | μSv | During surgery, mean 6.71 hours |
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| Secondary | Procedure Related Complications | Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication). | Posted | Number | Procedure related complications | During surgery, mean 6.71 hours |
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| Secondary | Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event | 21 patients enrolled, 20 patients treated with new image-guidance software | Posted | Number | Events | From start of enrollment until hospital discharge, approximately 51 days |
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| 0 |
| 20 |
| 1 |
| 20 |
| 4 |
| 20 |
| Postoperative pain | Surgical and medical procedures | Systematic Assessment |
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| Repeated Xper-CT | Surgical and medical procedures | Systematic Assessment |
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| Urticaria | Surgical and medical procedures | Systematic Assessment |
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