Adolescent Idiopathic ScoliosisNCT02781324
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
A study testing Posterior Spinal Fusion and Ultrasonic Bone Scalpel in people with Adolescent Idiopathic Scoliosis and Posterior Spinal Fusion, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion
- What is being tested?
- Posterior Spinal Fusion and Ultrasonic Bone Scalpel
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2018
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 10-18 years of age
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)
Who cannot join
- Plan for a posterior column osteotomy of Schwab Grade II or higher
- Prior spinal surgery
- Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
- Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
- Subjects with bleeding diatheses
- Non-idiopathic etiology for scoliosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial
The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.
- Being tested
- Posterior Spinal Fusion, Ultrasonic Bone Scalpel
- Keywords
- Ultrasonic Bone Scalpel, Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion, Estimated Blood Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Spinal FusionProcedure or surgery
Ultrasonic Bone ScalpelDevice
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Bone Scalpel Group | Experimental | Surgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. Receives: Procedure: Posterior Spinal Fusion; Device: Ultrasonic Bone Scalpel |
| Standard of Care Group | Active comparator | Surgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. Receives: Procedure: Posterior Spinal Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss/Level
Estimated blood loss is being obtained from the report generated by the cell saver.
Measured: Intraoperative
Secondary outcomes (2)
Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group
This outcome measure measures the number of patients with intraoperative and postoperative blood transfusions placed in the Ultrasonic Bone Scalpel Group and the Standard of Care Group.
Measured: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)
Procedure Time (Minutes)
Measured: Intraoperative (for duration of the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018
- Study completionJan 2018
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 Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumeet Garg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781324
- Sponsor's protocol ID
- 15-0036
- Status last verified
- Dec 2020
- First submitted
- 13 May 2016
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02781324
- Acronym / sponsor ID
- 15-0036
- Keywords
- Ultrasonic Bone Scalpel, Adolescent Idiopathic Scoliosis, Posterior Spinal Fusion, Estimated Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Bone Scalpel Group | Experimental | Procedure: Posterior Spinal Fusion, Device: Ultrasonic Bone ScalpelSurgeons will use the ultrasonic bone scalpel, to their discretion, along with standard of care manual devices when performing the posterior spinal fusion. |
| Standard of Care Group | Active comparator | Procedure: Posterior Spinal FusionSurgeons will use, to their discretion, only standard of care manual devices when performing the posterior spinal fusion. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 10-18 years of age
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)
Key exclusion criteria (6 listed)
- Plan for a posterior column osteotomy of Schwab Grade II or higher
- Prior spinal surgery
- Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
- Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
- Subjects with bleeding diatheses
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 |
|---|---|---|
| Posterior Spinal Fusion | Procedure or surgery | Standard of Care Group, Ultrasonic Bone Scalpel Group |
| Ultrasonic Bone Scalpel | Device | Ultrasonic Bone Scalpel Group |
Primary outcome
Estimated Blood Loss/Level
Time frame: Intraoperative
Estimated blood loss is being obtained from the report generated by the cell saver.
2 secondary outcomes
Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group
Time frame: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)
Procedure Time (Minutes)
Time frame: Intraoperative (for duration of the procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sumeet Garg, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Spinal Fusion and Ultrasonic Bone Scalpel in people with Adolescent Idiopathic Scoliosis and Posterior Spinal Fusion, run by University of Colorado, Denver at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2019). 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 Blood Loss/Level (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2021.