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Completed

NCT Number: NCT02781324

Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

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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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 10-18 years of age
  • Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
  • Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)

Exclusion criteria

  • 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

Treatment and study plan

Posterior spinal fusion

Procedure

Ultrasonic Bone Scalpel

Device

Primary outcomes

  1. Estimated Blood Loss/Level

    Time frame: Intraoperative

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

Secondary outcomes

  1. Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group

    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.

  2. Procedure Time (Minutes)

    Time frame: Intraoperative (for duration of the procedure)

Other outcomes

  1. Preoperative Major Cobb Angle (Degrees)

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

    measured from preoperative radiographs

  2. Postoperative Major Cobb Angle (Degrees)

    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

  3. Number of Vertebral Levels Fused

    Time frame: Intraoperative

  4. BMI Percentile at Surgery

    Time frame: Preoperative (on day of surgery)

  5. Weight (kg) at Surgery

    Time frame: Preoperative (on day of surgery)

  6. Percent of Participants With Lenke 1 Curve Pattern

    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.

  7. Preoperative Hematocrit

    Time frame: Preoperative (prior to first incision)

  8. Postoperative Hematocrit

    Time frame: Short Term Postoperative (12-18 hours after procedure)

  9. Intraoperative Use of Antifibrinolytic

    Time frame: Intraoperative

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 24, 2016
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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