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Posterior Spinal Fusion With Two Energy Dissection Techniques

NCT02465099 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-02-19

Study results available
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Summary

The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for soft tissue removal from vertebral surfaces. The aim of the present study is to compare blood loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will assess the possible influence of the device use in secondary perioperative outcomes.

Conditions

  • Scoliosis

Interventions

DEVICE

Ultrasonic Dissection (UD)

Ultrasonic energy will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (\>=6) PSF

DEVICE

Electrocautery Dissection (ED)

Electrocautery dissection will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (\>=6) PSF

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Edmund Kassis, M.D. · Ethicon, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2016-05-01
Completion
2016-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465099 on ClinicalTrials.gov