N/A
N=66
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis · Posterior Spinal Fusion
Bottom Line
View on ClinicalTrials.gov: NCT02781324 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Estimated Blood Loss/Level — 35.21; 38.68 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Posterior Spinal Fusion (Procedure); Ultrasonic Bone Scalpel (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2018
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 | — |
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.
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
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.