Idiopathic Adolescent ScoliosisNCT04119284
Safety Outcomes of Vertebral Body Tethering Technique
A study testing Anterior body tether (ABT) in people with Idiopathic Adolescent Scoliosis, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The objectives of this study is to assess whether the intervention (Anterior Vertebral Tethering) is a safe and efficacious method of anterior approach surgery for spinal deformity in pediatric scoliosis. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Idiopathic Adolescent Scoliosis
- What is being tested?
- Anterior body tether (ABT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 15 Dec 2023
- 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 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 curve of greater than or equal to 35 degrees and less than or equal to 60 degrees
- Lumbar curve less than 35 degrees
- Patient has already been identified for and recommended to have surgical intervention
- Spina bifida occulta is permitted
- Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the subject has not had any previous surgery for this, and no surgery is planned in the future
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 syndrome or neurofibromatosis
- Sanders bone age greater than 4
Show all 10Show fewer
- Thoracic curve less than 35 degrees or greater than 60 degrees
- Lumbar curve greater than or equal to 35 degrees
- 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
Nemours Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Safety and Efficacy of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
The objectives of this study is to assess whether the intervention (Anterior Vertebral Tethering) is a safe and efficacious method of anterior approach surgery for spinal deformity in pediatric scoliosis.
Read the detailed description
Scoliosis is a condition where the spine is deformed by a curvature in the coronal plane. It is generally associated with a twisting (axial plane) deformity as well.
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 Adolescent Idiopathic Scoliosis(AIS) 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 efficacy of Anterior Vertebral Body Tethering to avoid curve progression to more than 50 degrees.
- Conditions
- Idiopathic Adolescent Scoliosis
- Being tested
- Anterior body tether (ABT)
- Keywords
- scoliosis, Vertebral Body Tethering, curve, Shah
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior body tether (ABT)Device
Also called Reflect/Transition™ Stabilization System Polyethylene terephthalate (PET) cord
To insert the ABT in patients to correct AIS.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Vertebral Tethering | Experimental | Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. Receives: Device: Anterior body tether (ABT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events After the Procedure
We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections.
Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases.
The PI will determine if these events are related to the device.
Measured: 2 years after the surgery
Secondary outcomes (1)
Cobb Angle in Degrees
The difference between pre and post-operative Cobb angle measurements.
Measured: The difference between Cobb angles measured prior to surgery and 2 years past surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Sep 2019
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Why it stopped: IRB suspended the study.
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 Idiopathic Adolescent 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suken Shah, Nemours Children's Clinic
- Investigators
- Suken Shah, MD, Principal investigator, Nemours-AIDHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119284
- Sponsor's protocol ID
- 1365311
- Other IDs
- G180238
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2019
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04119284
- Acronym / sponsor ID
- 1365311
- Conditions
- Idiopathic Adolescent Scoliosis
- Keywords
- scoliosis, Vertebral Body Tethering, curve, Shah
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB suspended the study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study is to assess whether the intervention (Anterior Vertebral Tethering) is a safe and efficacious method of anterior approach surgery for spinal deformity in pediatric scoliosis.
Detailed description
Scoliosis is a condition where the spine is deformed by a curvature in the coronal plane. It is generally associated with a twisting (axial plane) deformity as well.
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 Adolescent Idiopathic Scoliosis(AIS) 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 efficacy of Anterior Vertebral Body Tethering to avoid curve progression to more than 50 degrees.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Vertebral Tethering | Experimental | Device: Anterior body tether (ABT)Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 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 curve of greater than or equal to 35 degrees and less than or equal to 60 degrees
- Lumbar curve less than 35 degrees
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 syndrome 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 body tether (ABT)Also: Reflect/Transition™ Stabilization System Polyethylene terephthalate (PET) cordTo insert the ABT in patients to correct AIS. | Device | Anterior Vertebral Tethering |
Primary outcome
Number of Adverse Events After the Procedure
Time frame: 2 years after the surgery
We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections. Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases. The PI will determine if these events are related to the device.
1 secondary outcome
Cobb Angle in Degrees
Time frame: The difference between Cobb angles measured prior to surgery and 2 years past surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Adolescent Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Suken Shah, MD principal investigator
Nemours-AIDHC
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 body tether (ABT) in people with Idiopathic Adolescent Scoliosis, run by Nemours Children's Clinic 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 8 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 13 Jan 2025. 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 13 Jan 2025). 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?
Number of Adverse Events After the Procedure (time frame: 2 years after the surgery). 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 2025.