Posterior Spinal Fusion With Two Energy Dissection Techniques

Perioperative Outcomes of Multilevel Posterior Spinal Fusion in Adolescent Scoliosis With Two Energy Dissection Techniques

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.

Study Overview

• Status: Terminated
• Conditions: Scoliosis
• Intervention / Treatment: Device: Electrocautery Dissection (ED); Device: Ultrasonic Dissection (UD)

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Madera, California, United States, 93638
      • Valley Children's Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours/Alfred I. duPont Hospital for Children
  • Illinois
    • Chicago, Illinois, United States, 60707
      • Shriners Hospital for Children - Chicago
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Shriners Hospitals for Children-Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Harmonic ultrasonic dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: ENG 14-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes