Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
Primary Purpose
Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterior Spinal Fusion
Ultrasonic Bone Scalpel
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Ultrasonic Bone Scalpel, Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion, Estimated Blood Loss
Eligibility Criteria
Inclusion Criteria:
- 10-18 years of age
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)
Exclusion Criteria:
- Plan for a posterior column osteotomy of Schwab Grade II or higher
- Prior spinal surgery
- Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
- Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
- Subjects with bleeding diatheses
- Non-idiopathic etiology for scoliosis
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasonic Bone Scalpel Group
Standard of Care Group
Arm Description
Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.
Outcomes
Primary Outcome Measures
Estimated Blood Loss/Level
Estimated blood loss is being obtained from the report generated by the cell saver.
Secondary Outcome Measures
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.
Procedure Time (Minutes)
Full Information
NCT ID
NCT02781324
First Posted
May 13, 2016
Last Updated
December 17, 2020
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02781324
Brief Title
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
Official Title
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion
Keywords
Ultrasonic Bone Scalpel, Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion, Estimated Blood Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasonic Bone Scalpel Group
Arm Type
Experimental
Arm Description
Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
Arm Title
Standard of Care Group
Arm Type
Active Comparator
Arm Description
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.
Intervention Type
Procedure
Intervention Name(s)
Posterior Spinal Fusion
Intervention Type
Device
Intervention Name(s)
Ultrasonic Bone Scalpel
Primary Outcome Measure Information:
Title
Estimated Blood Loss/Level
Description
Estimated blood loss is being obtained from the report generated by the cell saver.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group
Description
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)
Title
Procedure Time (Minutes)
Time Frame
Intraoperative (for duration of the procedure)
Other Pre-specified Outcome Measures:
Title
Preoperative Major Cobb Angle (Degrees)
Description
measured from preoperative radiographs
Time Frame
Preoperative (up to 1 month before scheduled date of surgery)
Title
Postoperative Major Cobb Angle (Degrees)
Description
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)
Title
Number of Vertebral Levels Fused
Time Frame
Intraoperative
Title
BMI Percentile at Surgery
Time Frame
Preoperative (on day of surgery)
Title
Weight (kg) at Surgery
Time Frame
Preoperative (on day of surgery)
Title
Percent of Participants With Lenke 1 Curve Pattern
Description
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)
Title
Preoperative Hematocrit
Time Frame
Preoperative (prior to first incision)
Title
Postoperative Hematocrit
Time Frame
Short Term Postoperative (12-18 hours after procedure)
Title
Intraoperative Use of Antifibrinolytic
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
10-18 years of age
Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)
Exclusion Criteria:
Plan for a posterior column osteotomy of Schwab Grade II or higher
Prior spinal surgery
Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
Subjects with bleeding diatheses
Non-idiopathic etiology for scoliosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumeet Garg, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
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