Clinical trial NCT02465099: Posterior Spinal Fusion With Two Energy Dissection Techniques
Official title: Perioperative Outcomes of Multilevel Posterior Spinal Fusion in Adolescent Scoliosis With Two Energy Dissection Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Scoliosis
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2015-06-08
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Estimated Intraoperative Blood Loss
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Chicago
country: United States
facility: Shriners Hospital for Children - Chicago
state: Illinois
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children-Philadelphia
state: Pennsylvania
Study officials:
affiliation: Ethicon, Inc.
name: Edmund Kassis, M.D.
role: STUDY_DIRECTOR
References: