Study Stopped
Terminated due to commercial considerations with no patient safety reasons.
Posterior Spinal Fusion With Two Energy Dissection Techniques
Perioperative Outcomes of Multilevel Posterior Spinal Fusion in Adolescent Scoliosis With Two Energy Dissection Techniques
1 other identifier
interventional
64
1 country
5
Brief Summary
The OSTEOVUEâ„¢ 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2015
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
February 19, 2018
CompletedFebruary 19, 2018
February 1, 2018
11 months
June 3, 2015
September 13, 2017
February 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Estimated Intraoperative Blood Loss
Estimated blood loss during intraoperative Stage 1, defined as the period from first incision to the first bone violation/cut (e.g., first pedicle screw drill); and intraoperative Stage 2, defined as the period from first bone violation/cut to last suture.
Intraoperative
Study Arms (2)
Electrocautery Dissection (ED)
ACTIVE COMPARATORPatients meeting the study criteria, scheduled to undergo posterior spinal fusion (PSF) using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
Ultrasonic Dissection (UD)
EXPERIMENTALPatients meeting the study criteria, scheduled to undergo PSF using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
Interventions
Ultrasonic energy will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (\>=6) PSF
Electrocautery dissection will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (\>=6) PSF
Eligibility Criteria
You may qualify if:
- Between 10 and 21 years of age;
- Diagnosed with neuromuscular scoliosis associated with cerebral palsy or with idiopathic scoliosis between the ages of 10 and 18;
- Indicated for primary PSF surgery;
- Anticipated \>= 6 vertebrae fusions;
- Not in need of three column osteotomy (pedicle subtraction osteotomy \[PSO\]);
- Not in need of vertebral column resection (VCR);
- Curve magnitude \>45 degrees for scoliosis and for sagittal deformity; and
- An American Society of Anesthesiologists (ASA) physical status (PS) classification of 1 to 4
You may not qualify if:
- One or both parents or a guardian unable or unwilling to provide parental permission and child assent (if capable, the child must express willingness to participate);
- Previous failed vertebral fusion at same target levels;
- Syndromic scoliosis;
- Congenital scoliosis;
- Early-onset scoliosis (onset before 10 years of age);
- Requiring an anterior procedure;
- Requiring PSO;
- Requiring VCR;
- Presence of coagulation abnormalities;
- Planned staged procedure (exclude if second stage or beyond);
- Requiring emergency surgery; and/or
- Participation in any other clinical study (not to include registry or survey-only studies) for the duration of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Valley Children's Hospital
Madera, California, 93638, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Shriners Hospital for Children - Chicago
Chicago, Illinois, 60707, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Shriners Hospitals for Children-Philadelphia
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated due to internal strategic considerations and not for any patient safety concerns.
Results Point of Contact
- Title
- Jason Waggoner
- Organization
- Ethicon Inc
Study Officials
- STUDY DIRECTOR
Edmund Kassis, M.D.
Ethicon, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2015
First Posted
June 8, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
February 19, 2018
Results First Posted
February 19, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make IPD available.