Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

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