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Vertebral Body Tethering Treatment for Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802656
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Lawrence Haber, Ochsner Health System

Brief Summary:
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.

Condition or disease Intervention/treatment Phase
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Disease Adolescent Idiopathic Scoliosis Juvenile; Scoliosis Device: Anterior Vertebral Body Tethering Not Applicable

Expanded Access : Lawrence Haber has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Anterior Vertebral Body Tethering
Subjects who will be undergoing the anterior vertebral body tethering surgery.
Device: Anterior Vertebral Body Tethering
Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.




Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. Feasibility: Incidence of Successfully Implanted Tether Devices [ Time Frame: 2 years after last subject's device implantation ]
    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.

  2. Efficacy: Comparison of Preoperative and Postoperative Cobb Angle [ Time Frame: 2 years after last subject's device implantation ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females age 8 to 16 years old at time of enrollment (inclusive)
  2. Diagnosis of idiopathic scoliosis
  3. Sanders bone age of less than or equal to 4
  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
  5. Lenke classification of 1, 2, 3, 5, or 6
  6. Patient has already been identified for and recommended to have surgical intervention
  7. Spina bifida occulta is permitted
  8. 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
  9. Completed standard-of-care procedures as outlined in Section 5

Exclusion Criteria:

  1. Pregnancy (current)
  2. Prior spinal or chest surgery
  3. MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
  4. Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
  5. Associated syndrome, including Marfan Disease or Neurofibromatosis
  6. Sanders bone age greater than 4
  7. Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees
  8. Compensatory curve greater than 35 degrees without intent to treat surgically
  9. Unable or unwilling to firmly commit to returning for required follow-up visits
  10. Investigator judgement that the subject/family may not be a candidate for the intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802656


Contacts
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Contact: Lawrence Haber, MD 504-842-8705 lawrence.haber@ochsner.org
Contact: Anna Strahan, NP 504-842-3970 anna.strahan@ochsner.org

Locations
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United States, Louisiana
Ochsner Health System- Jefferson Hwy Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Lawrence Haber, MD       lawrence.haber@ochsner.org   
Sponsors and Collaborators
Lawrence Haber
Investigators
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Principal Investigator: Lawrence Haber, MD Ochsner Health System
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Responsible Party: Lawrence Haber, Director of Pediatric Spine Surgery, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03802656    
Other Study ID Numbers: VBT120718
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Lawrence Haber, Ochsner Health System:
Scoliosis
Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Vertebral Body Tethering
growth modulation spine
spine
juvenile scoliosis
Additional relevant MeSH terms:
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Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spinal Curvatures