Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

University of Colorado, Denver66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Adolescent Idiopathic Scoliosis Posterior Spinal Fusion

Interventions

Posterior Spinal FusionPROCEDURE

Ultrasonic Bone ScalpelDEVICE

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Estimated Blood Loss/Level

Estimated blood loss is being obtained from the report generated by the cell saver.

Time frame: Intraoperative

Secondary Outcomes

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)

Procedure Time (Minutes)

Time frame: Intraoperative (for duration of the procedure)

Data from ClinicalTrials.gov

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