Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Adolescent Idiopathic Scoliosis Posterior Spinal Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Posterior Spinal Fusion

Intervention Type PROCEDURE

Ultrasonic Bone Scalpel

Intervention Type DEVICE

Standard of Care Group

Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion.

Group Type ACTIVE_COMPARATOR

Posterior Spinal Fusion

Intervention Type PROCEDURE

Interventions

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Posterior Spinal Fusion

Intervention Type PROCEDURE

Ultrasonic Bone Scalpel

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No