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Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Adolescent Idiopathic Scoliosis
Posterior Spinal Fusion

Treatments

Device: Ultrasonic Bone Scalpel
Procedure: Posterior Spinal Fusion

Study type

Interventional

Funder types

Other

Identifiers

NCT02781324
15-0036

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

Ultrasonic Bone Scalpel Group
Experimental group
Description:
Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion.
Treatment:
Procedure: Posterior Spinal Fusion
Device: Ultrasonic Bone Scalpel
Standard of Care Group
Active Comparator group
Description:
Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.
Treatment:
Procedure: Posterior Spinal Fusion

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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