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The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Experimental | Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. |
|
| Standard of Care Group | Active Comparator | Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior Spinal Fusion | Procedure |
| ||
| Ultrasonic Bone Scalpel |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss/Level | Estimated blood loss is being obtained from the report generated by the cell saver. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group | This outcome measure measures the number of patients with intraoperative and postoperative blood transfusions placed in the Ultrasonic Bone Scalpel Group and the Standard of Care Group. | Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Major Cobb Angle (Degrees) | measured from preoperative radiographs | Preoperative (up to 1 month before scheduled date of surgery) |
| Postoperative Major Cobb Angle (Degrees) | Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define Scoliosis. A Cobb angle of 10 degrees is the minimum angle to define scoliosis. Angles of 40-50 degrees or more may require corrective surgery. Cobb angle will be measured from postoperative radiographs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sumeet Garg, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasonic Bone Scalpel Group | Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel |
| FG001 | Standard of Care Group | Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasonic Bone Scalpel Group | Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel |
| BG001 | Standard of Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Estimated Blood Loss/Level | Estimated blood loss is being obtained from the report generated by the cell saver. | The above 65 patients were analyzed as part of a treated cohort and an intention-to-treat cohort. The discrepancy between the 65 patients with data evaluated and the 66 patients initially consented is explained by 1 patient who withdrew consent from the study. The study team therefore did not feel it was ethical to collect this patient's data. | Posted | Mean | Standard Deviation | mL | Intraoperative |
|
18 months
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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 | Ultrasonic Bone Scalpel Group | Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion Ultrasonic Bone Scalpel |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eun Kim, Spine Research Assistant | Children's Hospital Colorado | 720-777-8026 | eun.kim@childrenscolorado.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2015 | May 6, 2019 | Prot_SAP_000.pdf |
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| Device |
|
| Procedure Time (Minutes) | Intraoperative (for duration of the procedure) |
| Short Term Postoperative (3 month), Long Term Postoperative (1 year) |
| Number of Vertebral Levels Fused | Intraoperative |
| BMI Percentile at Surgery | Preoperative (on day of surgery) |
| Weight (kg) at Surgery | Preoperative (on day of surgery) |
| Percent of Participants With Lenke 1 Curve Pattern | Lenke Type 1 is a main thoracic curve pattern, and is the most common pattern observed in cases of adolescent idiopathic scoliosis (AIS). The Lenke Classification System provides surgeons with a simple, accurate, and reproducible way to communicate about scoliosis. It relies on measurements taken from standard x-rays. The surgeon evaluates the x-ray from the front, side, and in bending positions. Each scoliosis curve is then classified in three ways: by the curve type based on the three regions of the spine, a lumbar spine modifier, and a sagittal thoracic modifier. The classification system combines the curve type (1-6) with the lumbar modifier (A, B, C) and the sagittal thoracic modifier (-. N, +) to form the complete classification. | Preoperative (up to 1 month before scheduled date of surgery) |
| Preoperative Hematocrit | Preoperative (prior to first incision) |
| Postoperative Hematocrit | Short Term Postoperative (12-18 hours after procedure) |
| Intraoperative Use of Antifibrinolytic | Intraoperative |
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Standard of Care Group |
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion |
|
|
| Secondary | Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group | This outcome measure measures the number of patients with intraoperative and postoperative blood transfusions placed in the Ultrasonic Bone Scalpel Group and the Standard of Care Group. | Posted | Count of Participants | Participants | Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery) |
|
|
|
| Secondary | Procedure Time (Minutes) | Posted | Mean | Standard Deviation | minutes | Intraoperative (for duration of the procedure) |
|
|
|
| Other Pre-specified | Preoperative Major Cobb Angle (Degrees) | measured from preoperative radiographs | Posted | Mean | Standard Deviation | degrees | Preoperative (up to 1 month before scheduled date of surgery) |
|
|
|
| Other Pre-specified | Postoperative Major Cobb Angle (Degrees) | Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define Scoliosis. A Cobb angle of 10 degrees is the minimum angle to define scoliosis. Angles of 40-50 degrees or more may require corrective surgery. Cobb angle will be measured from postoperative radiographs | Not Posted | Short Term Postoperative (3 month), Long Term Postoperative (1 year) | Participants |
| Other Pre-specified | Number of Vertebral Levels Fused | Posted | Mean | Standard Deviation | vertebral levels | Intraoperative |
|
|
|
| Other Pre-specified | BMI Percentile at Surgery | Posted | Mean | Standard Deviation | percentile | Preoperative (on day of surgery) |
|
|
|
| Other Pre-specified | Weight (kg) at Surgery | Posted | Mean | Standard Deviation | kilograms | Preoperative (on day of surgery) |
|
|
|
| Other Pre-specified | Percent of Participants With Lenke 1 Curve Pattern | Lenke Type 1 is a main thoracic curve pattern, and is the most common pattern observed in cases of adolescent idiopathic scoliosis (AIS). The Lenke Classification System provides surgeons with a simple, accurate, and reproducible way to communicate about scoliosis. It relies on measurements taken from standard x-rays. The surgeon evaluates the x-ray from the front, side, and in bending positions. Each scoliosis curve is then classified in three ways: by the curve type based on the three regions of the spine, a lumbar spine modifier, and a sagittal thoracic modifier. The classification system combines the curve type (1-6) with the lumbar modifier (A, B, C) and the sagittal thoracic modifier (-. N, +) to form the complete classification. | Posted | Number | percentage of participants | Preoperative (up to 1 month before scheduled date of surgery) |
|
|
|
| Other Pre-specified | Preoperative Hematocrit | one less standard of care participant analyzed because labs were not drawn in designated window. | Posted | Mean | Standard Deviation | grams/deciliter | Preoperative (prior to first incision) |
|
|
|
| Other Pre-specified | Postoperative Hematocrit | deviation in numbers due to some postop labs not being drawn and therefore no postop hematocrit values were collected | Posted | Mean | Standard Deviation | grams/deciliter | Short Term Postoperative (12-18 hours after procedure) |
|
|
|
| Other Pre-specified | Intraoperative Use of Antifibrinolytic | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Standard of Care Group | Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Posterior Spinal Fusion | 0 | 31 | 0 | 31 | 0 | 31 |
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