Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion
Conditions
Keywords
Ultrasonic Bone Scalpel, Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion, Estimated Blood Loss
Brief summary
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.
Interventions
DEVICEUltrasonic Bone Scalpel
PROCEDUREPosterior Spinal Fusion
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. 10-18 years of age 2. Diagnosis of Adolescent Idiopathic Scoliosis (AIS) 3. Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)
Exclusion criteria
1. Plan for a posterior column osteotomy of Schwab Grade II or higher 2. Prior spinal surgery 3. Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations) 4. Subjects with medical comorbidities (e.g. heart, lung, kidney disease) 5. Subjects with bleeding diatheses 6. Non-idiopathic etiology for scoliosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss/Level | Intraoperative | Estimated blood loss is being obtained from the report generated by the cell saver. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group | Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery) | 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. |
| Procedure Time (Minutes) | Intraoperative (for duration of the procedure) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Preoperative (up to 1 month before scheduled date of surgery) | 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 Major Cobb Angle (Degrees) | Preoperative (up to 1 month before scheduled date of surgery) | measured from preoperative radiographs |
| Postoperative Hematocrit | Short Term Postoperative (12-18 hours after procedure) | — |
| Intraoperative Use of Antifibrinolytic | Intraoperative | — |
| Preoperative Hematocrit | Preoperative (prior to first incision) | — |
| Postoperative Major Cobb Angle (Degrees) | Short Term Postoperative (3 month), Long Term Postoperative (1 year) | 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 |
| Number of Vertebral Levels Fused | Intraoperative | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care Group | Ultrasonic Bone Scalpel Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 31 Participants | 62 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 21 Participants | 47 Participants |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 30 Participants | 22 Participants | 52 Participants |
| Sex: Female, Male Male | 1 Participants | 9 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Estimated Blood Loss/Level
Estimated blood loss is being obtained from the report generated by the cell saver.
Time frame: Intraoperative
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Estimated Blood Loss/Level | 35.21 mL | Standard Deviation 18.09 |
| Standard of Care Group | Estimated Blood Loss/Level | 38.68 mL | Standard Deviation 15.34 |
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.
Time frame: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonic Bone Scalpel Group | Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group | 32 Participants |
| Standard of Care Group | Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group | 33 Participants |
Secondary
Procedure Time (Minutes)
Time frame: Intraoperative (for duration of the procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Procedure Time (Minutes) | 157.5 minutes | Standard Deviation 39.46 |
| Standard of Care Group | Procedure Time (Minutes) | 159.7 minutes | Standard Deviation 36.25 |
Other Pre-specified
BMI Percentile at Surgery
Time frame: Preoperative (on day of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | BMI Percentile at Surgery | 53.92 percentile | Standard Deviation 28.42 |
| Standard of Care Group | BMI Percentile at Surgery | 55.7 percentile | Standard Deviation 25.63 |
Other Pre-specified
Intraoperative Use of Antifibrinolytic
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonic Bone Scalpel Group | Intraoperative Use of Antifibrinolytic | 32 Participants |
| Standard of Care Group | Intraoperative Use of Antifibrinolytic | 33 Participants |
Other Pre-specified
Number of Vertebral Levels Fused
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Number of Vertebral Levels Fused | 10.53 vertebral levels | Standard Deviation 2.74 |
| Standard of Care Group | Number of Vertebral Levels Fused | 10.55 vertebral levels | Standard Deviation 1.82 |
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.
Time frame: Preoperative (up to 1 month before scheduled date of surgery)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasonic Bone Scalpel Group | Percent of Participants With Lenke 1 Curve Pattern | 53 percentage of participants |
| Standard of Care Group | Percent of Participants With Lenke 1 Curve Pattern | 64 percentage of participants |
Other Pre-specified
Postoperative Hematocrit
Time frame: Short Term Postoperative (12-18 hours after procedure)
Population: deviation in numbers due to some postop labs not being drawn and therefore no postop hematocrit values were collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Postoperative Hematocrit | 30.39 grams/deciliter | Standard Deviation 10.7 |
| Standard of Care Group | Postoperative Hematocrit | 30.45 grams/deciliter | Standard Deviation 9.51 |
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
Time frame: Short Term Postoperative (3 month), Long Term Postoperative (1 year)
Other Pre-specified
Preoperative Hematocrit
Time frame: Preoperative (prior to first incision)
Population: one less standard of care participant analyzed because labs were not drawn in designated window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Preoperative Hematocrit | 38.24 grams/deciliter | Standard Deviation 5.77 |
| Standard of Care Group | Preoperative Hematocrit | 36.5 grams/deciliter | Standard Deviation 12.73 |
Other Pre-specified
Preoperative Major Cobb Angle (Degrees)
measured from preoperative radiographs
Time frame: Preoperative (up to 1 month before scheduled date of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Preoperative Major Cobb Angle (Degrees) | 49.78 degrees | Standard Deviation 8.37 |
| Standard of Care Group | Preoperative Major Cobb Angle (Degrees) | 51.15 degrees | Standard Deviation 7.7 |
Other Pre-specified
Weight (kg) at Surgery
Time frame: Preoperative (on day of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasonic Bone Scalpel Group | Weight (kg) at Surgery | 52.45 kilograms | Standard Deviation 10.37 |
| Standard of Care Group | Weight (kg) at Surgery | 54.14 kilograms | Standard Deviation 8.96 |