Scoliosis
Conditions
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.
Interventions
DEVICEUltrasonic 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
DEVICEElectrocautery 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
Sponsors
Children's Hospital Medical Center, Cincinnati
Ethicon Endo-Surgery
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Intraoperative Blood Loss | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Monopolar Electrocautery Dissection Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces. | 45 |
| Phase II OSTEOVUE Ultrasonic Dissection Patients meeting the study criteria, scheduled to undergo posterior spinal fusion using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces. | 19 |
| Total | 64 |
Baseline characteristics
| Characteristic | Phase 1 Monopolar Electrocautery Dissection | Phase II OSTEOVUE Ultrasonic Dissection | Total |
|---|---|---|---|
| Age, Continuous | 15.1 years STANDARD_DEVIATION 2.64 | 14.5 years STANDARD_DEVIATION 1.84 | 14.9 years STANDARD_DEVIATION 2.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 31 Participants | 16 Participants | 47 Participants |
| Region of Enrollment United States | 45 participants | 19 participants | 64 participants |
| Sex: Female, Male Female | 37 Participants | 14 Participants | 51 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 18 |
| serious Total, serious adverse events | 0 / 45 | 0 / 18 |
Outcome results
Primary
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.
Time frame: Intraoperative
Population: All subjects in which the procedure was started. There was one subject that was enrolled who was to receive treatment with ultrasonic dissection, but the procedure was not performed due to study closure. Therefore, N=19 subjects enrolled for the ultrasonic dissection group, but only 18 subjects received treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Monopolar Electrocautery Dissection | Estimated Intraoperative Blood Loss | 134 milliliters | Standard Deviation 124 |
| Phase II OSTEOVUE Ultrasonic Dissection | Estimated Intraoperative Blood Loss | 163 milliliters | Standard Deviation 146 |