Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Completed · Not applicable

Conditions studied: Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion

In brief

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.

Key facts

Study ID

NCT02781324

Run by

University of Colorado, Denver

People needed

66

Starts

2016-06-01

Expected to finish

2018-01-01

Last updated by the study team

2021-01-13

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 10-18 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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