N/A Completed N=66 Randomized Double-blind Treatment

Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis · Posterior Spinal Fusion

Source: ClinicalTrials.gov NCT02781324 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcomePrimary: Estimated Blood Loss/Level — 35.21; 38.68 mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Estimated Blood Loss/Level	35.21; 38.68	—
SECONDARY Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group	32; 33	—
SECONDARY Procedure Time (Minutes)	157.5; 159.7	—

Eligibility Criteria

Inclusion Criteria

10-18 years of age
Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)

Exclusion Criteria

Plan for a posterior column osteotomy of Schwab Grade II or higher
Prior spinal surgery
Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
Subjects with bleeding diatheses
Non-idiopathic etiology for scoliosis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02781324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.