Children's Hospital Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT02781324
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.
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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intraoperative
Estimated blood loss is being obtained from the report generated by the cell saver.
Time frame: 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.
Time frame: Intraoperative (for duration of the procedure)
Time frame: Preoperative (up to 1 month before scheduled date of surgery)
measured from preoperative radiographs
Time frame: Short Term Postoperative (3 month), Long Term Postoperative (1 year)
Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define Scoliosis. A Cobb angle of 10 degrees is the minimum angle to define scoliosis. Angles of 40-50 degrees or more may require corrective surgery. Cobb angle will be measured from postoperative radiographs
Time frame: Intraoperative
Time frame: Preoperative (on day of surgery)
Time frame: Preoperative (on day of surgery)
Time frame: Preoperative (up to 1 month before scheduled date of surgery)
Lenke Type 1 is a main thoracic curve pattern, and is the most common pattern observed in cases of adolescent idiopathic scoliosis (AIS). The Lenke Classification System provides surgeons with a simple, accurate, and reproducible way to communicate about scoliosis. It relies on measurements taken from standard x-rays. The surgeon evaluates the x-ray from the front, side, and in bending positions. Each scoliosis curve is then classified in three ways: by the curve type based on the three regions of the spine, a lumbar spine modifier, and a sagittal thoracic modifier. The classification system combines the curve type (1-6) with the lumbar modifier (A, B, C) and the sagittal thoracic modifier (-. N, +) to form the complete classification.
Time frame: Preoperative (prior to first incision)
Time frame: Short Term Postoperative (12-18 hours after procedure)
Time frame: Intraoperative
University of Colorado, Denver
Other
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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