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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 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Brief 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.

Condition or disease Intervention/treatment Phase
Scoliosis Device: Ultrasonic Dissection (UD) Device: Electrocautery Dissection (ED) Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 10 and 21 years of age;
  2. Diagnosed with neuromuscular scoliosis associated with cerebral palsy or with idiopathic scoliosis between the ages of 10 and 18;
  3. Indicated for primary PSF surgery;
  4. Anticipated >= 6 vertebrae fusions;
  5. Not in need of three column osteotomy (pedicle subtraction osteotomy [PSO]);
  6. Not in need of vertebral column resection (VCR);
  7. Curve magnitude >45 degrees for scoliosis and for sagittal deformity; and
  8. An American Society of Anesthesiologists (ASA) physical status (PS) classification of 1 to 4

Exclusion Criteria:

  1. 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);
  2. Previous failed vertebral fusion at same target levels;
  3. Syndromic scoliosis;
  4. Congenital scoliosis;
  5. Early-onset scoliosis (onset before 10 years of age);
  6. Requiring an anterior procedure;
  7. Requiring PSO;
  8. Requiring VCR;
  9. Presence of coagulation abnormalities;
  10. Planned staged procedure (exclude if second stage or beyond);
  11. Requiring emergency surgery; and/or
  12. Participation in any other clinical study (not to include registry or survey-only studies) for the duration of the study.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Ethicon Endo-Surgery
Children's Hospital Medical Center, Cincinnati
Investigators
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Study Director: Edmund Kassis, M.D. Ethicon, Inc.

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Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT02465099     History of Changes
Other Study ID Numbers: ENG 14-004
First Posted: June 8, 2015    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases