Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion
• Interventions: Procedure: Posterior Spinal Fusion; Device: Ultrasonic Bone Scalpel

• Registration Number: NCT02781324
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Study Start: 2016-06
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Results First Submitted: 2019-05-13
• Results First Submitted QC: 2019-05-13
• Results First Posted: 2019-06-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonic Bone Scalpel Group	Ultrasonic Bone Scalpel	Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
Ultrasonic Bone Scalpel Group	Posterior Spinal Fusion	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	Posterior Spinal Fusion	Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss/Level	Intraoperative	Estimated blood loss is being obtained from the report generated by the cell saver.

Secondary Outcome Measures

Name	Time	Method
Procedure Time (Minutes)	Intraoperative (for duration of the procedure)
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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States