ScoliosisNCT03802656
Vertebral Body Tethering Treatment for Idiopathic Scoliosis
A study testing Anterior Vertebral Body Tethering in people with Scoliosis and Spinal Curvatures, run by Ochsner Health System at 1 site in United States.
Trial summary
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Scoliosis, Spinal Curvatures, Spinal Diseases
- What is being tested?
- Anterior Vertebral Body Tethering
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females age 8 to 16 years old at time of enrollment (inclusive)
- Diagnosis of idiopathic scoliosis
- Sanders bone age of less than or equal to 4
- Thoracic or thoracolumbar/lumbar curves of greater than or equal to 35 degrees and less than or equal to 60 degrees from levels T4 through L3
- Lenke classification of 1, 2, 3, 5, or 6
- Patient has already been identified for and recommended to have surgical intervention
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- Spina bifida occulta is permitted
- Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the patient has not had any previous surgery for this, and no surgery is planned in the future
- Completed standard-of-care procedures as outlined in Section 5
Who cannot join
- Pregnancy (current)
- Prior spinal or chest surgery
- MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- Associated syndrome, including Marfan Disease or Neurofibromatosis
- Sanders bone age greater than 4
Show all 10Show fewer
- Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees
- Compensatory curve greater than 35 degrees without intent to treat surgically
- Unable or unwilling to firmly commit to returning for required follow-up visits
- Investigator judgement that the subject/family may not be a candidate for the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Health System- Jefferson Hwy
New Orleans, Louisiana, 70121
About this study
Official title: Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
Read the detailed description
Scoliosis is a condition in which the spine is deformed by a curvature in the coronal plane. It is generally associated with a twisting (axial plane) deformity as well. It can have a variety of underlying etiologies and the etiology is used to classify the types of scoliosis. Idiopathic scoliosis is sub-classified in two ways: by age of onset and by magnitude of deformity. Curves between 10 and 25 degrees are considered mild. Curves between 25 and 50 degrees are classified as moderate. Curves greater than 50 degrees are termed severe. The current standard of care for moderate scoliosis in patients with remaining growth is to utilize a thoracolumbosacral orthosis (TLSO brace) to prevent progression of deformity. The scientific evidence has supported the efficacy of this intervention in avoiding progression of the Cobb angle to 50 degrees or more.
If treated with a TLSO brace, many idiopathic scoliosis patients would conceivably be subjected to years of brace wear and the cost and psychological factors inherent therein. Additional downsides of brace treatment include the potentially negative psychosocial impact of wearing an external sign of deformity during adolescence, a key period of emotional development. Prior research has identified negative psychosocial effects related to wearing a brace in children.
Recent evidence has suggested that certain curve patterns will likely progress to 50 degrees or more, despite treatment with a TLSO brace. Sanders, et al. demonstrated a correlation of Cobb angle (greater than 35 degrees) and skeletal maturity (bone age 4 or less) to the risk of progression to 50 degrees or more, despite TLSO bracing. The evidence supports that the current practice of TLSO bracing is not an effective treatment to avoid progression to 50 degrees in these patients. It is on this population (thoracic Cobb angle greater than 35 degrees, bone age of 4 or less) that we intend to test the safety and feasibility of Anterior Vertebral Body Tethering to avoid curve progression to 50 degrees.
The study intervention is surgical orthopedic implantation of the Anterior Vertebral Tether Device, by way of thoracoscopic surgery under general anesthesia. The primary outcome measures include assessments of safety of the insertion procedure and of the device, as well as the secondary measure of feasibility by determining the ability to successfully implant the investigational device.
- Conditions
- Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Diseases, Musculoskeletal Disease, Adolescent Idiopathic Scoliosis
- Being tested
- Anterior Vertebral Body Tethering
- Keywords
- Scoliosis, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Vertebral Body Tethering, growth modulation spine, spine, juvenile scoliosis
- Medical subject headings
- Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Vertebral Body TetheringDevice
Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Vertebral Body Tethering | Experimental | Subjects who will be undergoing the anterior vertebral body tethering surgery. Receives: Device: Anterior Vertebral Body Tethering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of Treatment-Emergent Adverse Events
Intraoperative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".
Measured: 2 years after last subject's device implantation
Secondary outcomes (2)
Feasibility: Incidence of Successfully Implanted Tether Devices
The feasibility of the vertebral body tethering device will analyzed based on successful implantation of the device. Implantation will be considered a failure if the device breaks/loosens after implantation, or if it overcorrects the spinal curve.
Measured: 2 years after last subject's device implantation
Efficacy: Comparison of Preoperative and Postoperative Cobb Angle
The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.
Measured: 2 years after last subject's device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start24 Jun 2019
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Why it stopped: Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Haber, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802656
- Sponsor's protocol ID
- VBT120718
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03802656
- Acronym / sponsor ID
- VBT120718
- Conditions
- Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Diseases, Musculoskeletal Disease, Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis, Vertebral Body Tethering, growth modulation spine, spine, juvenile scoliosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
Detailed description
Scoliosis is a condition in which the spine is deformed by a curvature in the coronal plane. It is generally associated with a twisting (axial plane) deformity as well. It can have a variety of underlying etiologies and the etiology is used to classify the types of scoliosis. Idiopathic scoliosis is sub-classified in two ways: by age of onset and by magnitude of deformity. Curves between 10 and 25 degrees are considered mild. Curves between 25 and 50 degrees are classified as moderate. Curves greater than 50 degrees are termed severe. The current standard of care for moderate scoliosis in patients with remaining growth is to utilize a thoracolumbosacral orthosis (TLSO brace) to prevent progression of deformity. The scientific evidence has supported the efficacy of this intervention in avoiding progression of the Cobb angle to 50 degrees or more.
If treated with a TLSO brace, many idiopathic scoliosis patients would conceivably be subjected to years of brace wear and the cost and psychological factors inherent therein. Additional downsides of brace treatment include the potentially negative psychosocial impact of wearing an external sign of deformity during adolescence, a key period of emotional development. Prior research has identified negative psychosocial effects related to wearing a brace in children.
Recent evidence has suggested that certain curve patterns will likely progress to 50 degrees or more, despite treatment with a TLSO brace. Sanders, et al. demonstrated a correlation of Cobb angle (greater than 35 degrees) and skeletal maturity (bone age 4 or less) to the risk of progression to 50 degrees or more, despite TLSO bracing. The evidence supports that the current practice of TLSO bracing is not an effective treatment to avoid progression to 50 degrees in these patients. It is on this population (thoracic Cobb angle greater than 35 degrees, bone age of 4 or less) that we intend to test the safety and feasibility of Anterior Vertebral Body Tethering to avoid curve progression to 50 degrees.
The study intervention is surgical orthopedic implantation of the Anterior Vertebral Tether Device, by way of thoracoscopic surgery under general anesthesia. The primary outcome measures include assessments of safety of the insertion procedure and of the device, as well as the secondary measure of feasibility by determining the ability to successfully implant the investigational device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Vertebral Body Tethering | Experimental | Device: Anterior Vertebral Body TetheringSubjects who will be undergoing the anterior vertebral body tethering surgery. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Males or females age 8 to 16 years old at time of enrollment (inclusive)
- Diagnosis of idiopathic scoliosis
- Sanders bone age of less than or equal to 4
- Thoracic or thoracolumbar/lumbar curves of greater than or equal to 35 degrees and less than or equal to 60 degrees from levels T4 through L3
- Lenke classification of 1, 2, 3, 5, or 6
Key exclusion criteria (10 listed)
- Pregnancy (current)
- Prior spinal or chest surgery
- MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- Associated syndrome, including Marfan Disease or Neurofibromatosis
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 |
|---|---|---|
| Anterior Vertebral Body TetheringVertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance. | Device | Anterior Vertebral Body Tethering |
Primary outcome
Safety: Incidence of Treatment-Emergent Adverse Events
Time frame: 2 years after last subject's device implantation
Intraoperative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".
2 secondary outcomes
Feasibility: Incidence of Successfully Implanted Tether Devices
Time frame: 2 years after last subject's device implantation
Efficacy: Comparison of Preoperative and Postoperative Cobb Angle
Time frame: 2 years after last subject's device implantation
Results and safety
The study was stopped early (reason given: Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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.
Lawrence Haber, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Vertebral Body Tethering in people with Scoliosis and Spinal Curvatures, run by Ochsner Health System 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 9 inclusion and 10 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 12 Apr 2023. 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?
The study was stopped early (reason given: Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.). Results are not available in the source record.
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?
Safety: Incidence of Treatment-Emergent Adverse Events (time frame: 2 years after last subject's device implantation). 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 12 Apr 2023.