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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

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
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".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vertebral Body Tethering Treatment for Idiopathic Scoliosis
Official Title  ICMJE Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Scoliosis
  • Spinal Curvatures
  • Spinal Diseases
  • Bone Diseases
  • Musculoskeletal Disease
  • Adolescent Idiopathic Scoliosis
  • Juvenile; Scoliosis
Intervention  ICMJE Device: Anterior Vertebral Body Tethering
Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
Study Arms  ICMJE Experimental: Anterior Vertebral Body Tethering
Subjects who will be undergoing the anterior vertebral body tethering surgery.
Intervention: Device: Anterior Vertebral Body Tethering
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lawrence Haber, MD 504-842-8705 lawrence.haber@ochsner.org
Contact: Anna Strahan, NP 504-842-3970 anna.strahan@ochsner.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802656
Other Study ID Numbers  ICMJE VBT120718
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lawrence Haber, Ochsner Health System
Study Sponsor  ICMJE Lawrence Haber
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lawrence Haber, MD Ochsner Health System
PRS Account Ochsner Health System
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP