Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781324
• Other study ID #: 15-0036
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Posterior Spinal Fusion
• Scoliosis

Intervention

Procedure:
• Posterior Spinal Fusion

Device:
• Ultrasonic Bone Scalpel

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preoperative Major Cobb Angle (Degrees)	measured from preoperative radiographs	Preoperative (up to 1 month before scheduled date of surgery)
Other	Postoperative Major Cobb Angle (Degrees)	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	Short Term Postoperative (3 month), Long Term Postoperative (1 year)
Other	Number of Vertebral Levels Fused		Intraoperative
Other	BMI Percentile at Surgery		Preoperative (on day of surgery)
Other	Weight (kg) at Surgery		Preoperative (on day of surgery)
Other	Percent of Participants With Lenke 1 Curve Pattern	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.	Preoperative (up to 1 month before scheduled date of surgery)
Other	Preoperative Hematocrit		Preoperative (prior to first incision)
Other	Postoperative Hematocrit		Short Term Postoperative (12-18 hours after procedure)
Other	Intraoperative Use of Antifibrinolytic		Intraoperative
Primary	Estimated Blood Loss/Level	Estimated blood loss is being obtained from the report generated by the cell saver.	Intraoperative
Secondary	Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group	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.	Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)
Secondary	Procedure Time (Minutes)		Intraoperative (for duration of the procedure)