Posterior Spinal Fusion With Two Energy Dissection Techniques
Stopped early · Phase 4
Conditions studied: Scoliosis
In brief
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.
Key facts
- Study ID
- NCT02465099
- Run by
- Ethicon Endo-Surgery
- People needed
- 64
- Starts
- 2015-06-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2018-02-19
Who can join
Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Valley Children's Hospital — Madera, California, United States
- Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
- Shriners Hospital for Children - Chicago — Chicago, Illinois, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Shriners Hospitals for Children-Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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