Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

NCT02781324 | Completed Results DMC

• 1 other identifier: 15-0036
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion

Keywords

Ultrasonic Bone Scalpel; Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion; Estimated Blood Loss

Outcome Measures

Primary Outcomes (1)

• Estimated Blood Loss/Level

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

  Intraoperative

Secondary Outcomes (2)

• 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)

• Procedure Time (Minutes)

  Intraoperative (for duration of the procedure)

Other Outcomes (9)

• Preoperative Major Cobb Angle (Degrees)

  Preoperative (up to 1 month before scheduled date of surgery)

• Postoperative Major Cobb Angle (Degrees)

  Short Term Postoperative (3 month), Long Term Postoperative (1 year)

• Number of Vertebral Levels Fused

  Intraoperative

Study Arms (2)

Ultrasonic Bone Scalpel Group

EXPERIMENTAL

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; Device: Ultrasonic Bone Scalpel

Standard of Care Group

ACTIVE COMPARATOR

Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.

Procedure: Posterior Spinal Fusion

Interventions

Posterior Spinal Fusion PROCEDURE

Standard of Care Group; Ultrasonic Bone Scalpel Group

Ultrasonic Bone Scalpel DEVICE

Ultrasonic Bone Scalpel Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
• Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

• Title: Eun Kim, Spine Research Assistant
• Organization: Children's Hospital Colorado

eun.kim@childrenscolorado.org

720-777-8026

Study Officials

• Sumeet Garg, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 24, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 13, 2021
• Results First Posted: June 7, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)