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Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT02781324
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment
Adolescent Idiopathic Scoliosis Posterior Spinal Fusion Procedure: Posterior Spinal Fusion Device: Ultrasonic Bone Scalpel

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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

  2. 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) ]
  3. Procedure Time (minutes) [ Time Frame: Intraoperative ]

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

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

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

  14. Intraoperative use of antifibrinolytic [ Time Frame: Intraoperative ]
  15. 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

  16. 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) ]


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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

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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02781324     History of Changes
Other Study ID Numbers: 15-0036
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 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