Posterior Spinal Fusion With Two Energy Dissection Techniques
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|ClinicalTrials.gov Identifier: NCT02465099|
Recruitment Status : Terminated (Terminated due to commercial considerations with no patient safety reasons.)
First Posted : June 8, 2015
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis||Device: Ultrasonic Dissection (UD) Device: Electrocautery Dissection (ED)||Phase 4|
The primary objective is to compare intraoperative blood loss between surgeries performed with monopolar electrocautery and ultrasonic energy (as the primary means for soft tissue dissection) in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) posterior spinal fusion (PSF).
This is a prospective, multicenter, pair-matched comparison study that will be carried out in two phases:
Phase I Perioperative outcome variables (primary and secondary) will be collected from patients with adolescent scoliosis, meeting the study inclusion criteria, scheduled to undergo PSF using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces. This group will be the Electrocautery Dissection (ED) group.
Phase II The same outcomes variables measured on the ED group during Phase I will be subsequently collected from a group of patients with adolescent scoliosis, meeting the study inclusion criteria and scheduled to undergo PSF surgery. For this study group, surgery will be performed with the Harmonic OSTEOVUE™ Spine Soft Tissue Dissector (referred to as the OSTEOVUE™ Dissector in this protocol) and metal Cobb elevator, as the primary means of soft tissue dissection and removal from vertebral surfaces. This group will be the Ultrasonic Dissection (UD) group.
Patients in the UD group will be recruited from the existing patient population of PSF candidates at each participating site.
Prior to recruitment of participants in Phase II, each Principal Investigator (PI) will have documented training/in service of the use the OSTEOVUE™ Dissector in at least 5 multilevel spine surgery cases.
The proportion of neuromuscular versus idiopathic cases recruited in Phase II will be based on the proportion of patients with either of these conditions recruited in Phase I.
Up to five US sites of orthopedic surgeons and/or neurosurgeons, with expertise in pediatric PSF surgery, will participate in the study. 100 subjects will be enrolled in this study (46 in the ED group and 54 in the UD group).
Propensity score matching will be utilized to match subjects in the ED group to subjects in the UD group. Propensity scores will be based on the variables known to influence blood loss, and full details of the matching methodology will be provided in a separate Statistical Analysis Plan.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perioperative Outcomes of Multilevel Posterior Spinal Fusion in Adolescent Scoliosis With Two Energy Dissection Techniques|
|Actual Study Start Date :||June 1, 2015|
|Actual Primary Completion Date :||May 1, 2016|
|Actual Study Completion Date :||May 1, 2016|
Active Comparator: Electrocautery Dissection (ED)
Patients 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.
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
Experimental: Ultrasonic Dissection (UD)
Patients meeting the study criteria, scheduled to undergo PSF using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
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
Other Name: Harmonic ultrasonic dissection
- Estimated Intraoperative Blood Loss [ Time Frame: Intraoperative ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465099
|United States, California|
|Valley Children's Hospital|
|Madera, California, United States, 93638|
|United States, Delaware|
|Nemours/Alfred I. duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|United States, Illinois|
|Shriners Hospital for Children - Chicago|
|Chicago, Illinois, United States, 60707|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|Shriners Hospitals for Children-Philadelphia|
|Philadelphia, Pennsylvania, United States, 19140|
|Study Director:||Edmund Kassis, M.D.||Ethicon, Inc.|