Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:10 - 18
Updated:10/13/2018
Start Date:June 2016
End Date:January 2019

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

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.


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
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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from
Aurora, CO
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