Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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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.

Official Title
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Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial

Conditions
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Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion

Intervention / Treatment
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* Procedure: Posterior Spinal Fusion
* Device: Ultrasonic Bone Scalpel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonic Bone Scalpel Group<br>Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. | Procedure: Posterior Spinal Fusion<br> <br> Device: Ultrasonic Bone Scalpel<br> <br> |
| Active Comparator: Standard of Care Group<br>Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. | Procedure: Posterior Spinal Fusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss/Level | Estimated blood loss is being obtained from the report generated by the cell saver. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| Procedure Time (Minutes) |  | Intraoperative (for duration of the procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonic Bone Scalpel, Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion, Estimated Blood Loss