ScoliosisPhase 4NCT02465099

Posterior Spinal Fusion With Two Energy Dissection Techniques

A Phase 4 study testing Ultrasonic Dissection (UD) and Electrocautery Dissection (ED) in people with Scoliosis, run by Ethicon Endo-Surgery at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 10 to 21 years
Conditions the study is for: Scoliosis
What is being tested?: Ultrasonic Dissection (UD) and Electrocautery Dissection (ED)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 5 sitesUnited States
Study dates: 1 Jun 2015to 1 May 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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);
Previous failed vertebral fusion at same target levels;
Syndromic scoliosis;
Congenital scoliosis;
Early-onset scoliosis (onset before 10 years of age);
Requiring an anterior procedure;

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Requiring PSO;
Requiring VCR;
Presence of coagulation abnormalities;
Planned staged procedure (exclude if second stage or beyond);
Requiring emergency surgery; and/or
Participation in any other clinical study (not to include registry or survey-only studies) for the duration of the study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Scoliosis
Being tested: Ultrasonic Dissection (UD), Electrocautery Dissection (ED)
Medical subject headings: Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasonic Dissection (UD)Device
Also called Harmonic ultrasonic dissection
Ultrasonic energy will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF
Electrocautery Dissection (ED)Device
Electrocautery dissection will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF

Study groups in NCT02465099
Study group	Role	What they receive
Electrocautery Dissection (ED)	Active comparator	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. Receives: Device: Electrocautery Dissection (ED)
Ultrasonic Dissection (UD)	Experimental	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. Receives: Device: Ultrasonic Dissection (UD)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20151 May 2016

First posted8 Jun 2015 (estimated)
Study start1 Jun 2015
Primary completion1 May 2016
Study completion1 May 2016

Why it stopped: Terminated due to commercial considerations with no patient safety reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ScoliosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02465099
Sponsor's protocol ID: ENG 14-004
Status last verified: Feb 2018
First submitted: 3 Jun 2015
Last updated: 19 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to make IPD available.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
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All Scoliosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perioperative Outcomes of Multilevel Posterior Spinal Fusion in Adolescent Scoliosis With Two Energy Dissection Techniques
ClinicalTrials.gov ID: NCT02465099
Acronym / sponsor ID: ENG 14-004
Conditions: Scoliosis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to commercial considerations with no patient safety reasons.
Enrolment: 64 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Collaborators: Children's Hospital Medical Center, Cincinnati
Study start: 1 Jun 2015 (actual)
Primary completion: 1 May 2016 (actual)
Study completion: 1 May 2016 (actual)
First posted: 8 Jun 2015 (estimated)
Results: Posted 19 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a prospective, multicenter, pair-matched comparison study that will be carried out in two phases:

Patients in the UD group will be recruited from the existing patient population of PSF candidates at each participating site.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Electrocautery Dissection (ED)	Active comparator	Device: 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.
Ultrasonic Dissection (UD)	Experimental	Device: 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.

Who may qualify

Ages: 10 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Between 10 and 21 years of age;
Diagnosed with neuromuscular scoliosis associated with cerebral palsy or with idiopathic scoliosis between the ages of 10 and 18;
Indicated for primary PSF surgery;
Anticipated >= 6 vertebrae fusions;
Not in need of three column osteotomy (pedicle subtraction osteotomy [PSO]);

Key exclusion criteria (12 listed)

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);
Previous failed vertebral fusion at same target levels;
Syndromic scoliosis;
Congenital scoliosis;
Early-onset scoliosis (onset before 10 years of age);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ultrasonic Dissection (UD)Also: Harmonic ultrasonic dissectionUltrasonic energy will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF	Device	Ultrasonic Dissection (UD)
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	Device	Electrocautery Dissection (ED)

Primary outcome

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.

Results and safety

Results posted to the registry on 19 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 Monopolar Electrocautery Dissection	45	45
Phase II OSTEOVUE Ultrasonic Dissection	19	19

Primary outcome: Estimated Intraoperative Blood Loss

Time frame: Intraoperative. Mean (Standard Deviation). Unit: milliliters

Measure	Phase 1 Monopolar Electrocautery Dissection n = 45	Phase II OSTEOVUE Ultrasonic Dissection n = 18
Value	134 (124)	163 (146)

Population analysed: 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.

Adverse events

Time frame: Intraoperatively through hospital discharge (average of 5 days with range of 2 to 24 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 Monopolar Electrocautery Dissection	0 of 45 (0%)	0 of 45 (0%)	Not reported
Phase II OSTEOVUE Ultrasonic Dissection	0 of 18 (0%)	0 of 18 (0%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated due to internal strategic considerations and not for any patient safety concerns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to make IPD available.

Related trials for Scoliosis

Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
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Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edmund Kassis, M.D. study director

Ethicon, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ultrasonic Dissection (UD) and Electrocautery Dissection (ED) in people with Scoliosis, run by Ethicon Endo-Surgery at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated Intraoperative Blood Loss (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02465099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018; AzTrials last refreshed its copy on 26 Oct 2026.