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Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781324
First Posted: May 24, 2016
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition Intervention
Adolescent Idiopathic Scoliosis Posterior Spinal Fusion Procedure: Posterior Spinal Fusion Device: Ultrasonic Bone Scalpel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Estimated blood loss/level [ Time Frame: Intraoperative ]
    Estimated blood loss is being obtained from the report generated by the cell saver.


Secondary Outcome Measures:
  • Intraoperative and postoperative complications [ Time Frame: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery), Long Term Postoperative (up to 1 year after surgery) ]
    Events that cause a deviation from routine care

  • Intraoperative and postoperative blood transfusions (type of transfusion, amount transfused in cc's) [ Time Frame: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery) ]
  • Procedure Time (minutes) [ Time Frame: Intraoperative ]

Other Outcome Measures:
  • Age at Surgery (years) [ Time Frame: Preoperative (on day of surgery) ]
  • Gender at Surgery (Male of Female) [ Time Frame: Preoperative (on day of surgery) ]
  • Exposure to second hand smoke (yes or no) [ Time Frame: Preoperative (up to 1 month before scheduled date of surgery) ]
  • Preoperative major Cobb angle (degrees) [ Time Frame: Preoperative (up to 1 month before scheduled date of surgery) ]
    measured from preoperative radiographs

  • Postoperative major Cobb angle (degrees) [ Time Frame: Short Term Postoperative (3 month), Long Term Postoperative (1 year) ]
    measured from postoperative radiographs

  • Intraoperative use of intrathecal narcotics [ Time Frame: Intraoperative ]
  • Number of vertebral levels fused [ Time Frame: Intraoperative ]
  • BMI percentile at surgery [ Time Frame: Preoperative (on day of surgery) ]
  • Weight (kg) at surgery [ Time Frame: Preoperative (on day of surgery) ]
  • Preoperative Lenke Classification (from Lenke Classification System for Scoliosis) [ Time Frame: Preoperative (up to 1 month before scheduled date of surgery) ]
  • Preoperative hemoglobin/hematocrit [ Time Frame: Preoperative (prior to first incision) ]
  • Postoperative hemoglobin/hematocrit [ Time Frame: Short Term Postoperative (12-18 hours after procedure) ]
  • Hematocrit of donor blood used in allogenic transfusion [ Time Frame: Intraoperative ]
    Taken by hematologist prior to transfusion

  • Intraoperative use of antifibrinolytic [ Time Frame: Intraoperative ]
  • Occurrence of surgical site infection (based on most current CDC definition) [ Time Frame: Long Term Postoperative (up to 1 year after surgery) ]
    Collecting: time to infection, deep vs. superficial, treatment

  • Unplanned return to OR (time to return, reason for return, procedure) [ Time Frame: Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery), Long Term Postoperative (up to 1 year after surgery) ]

Estimated Enrollment: 72
Study Start Date: June 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasonic Bone Scalpel Group
Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
Procedure: Posterior Spinal Fusion Device: Ultrasonic Bone Scalpel
Active Comparator: Standard of Care Group
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.
Procedure: Posterior Spinal Fusion

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781324


Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Sumeet Garg, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02781324     History of Changes
Other Study ID Numbers: 15-0036
First Submitted: May 13, 2016
First Posted: May 24, 2016
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Ultrasonic Bone Scalpel
Adolescent Idiopathic Scoliosis
Posterior Spinal Fusion
Estimated Blood Loss

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases