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Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT03194568
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Cahill, MD, Children's Hospital of Philadelphia

Brief Summary:
This study will assess whether Anterior Vertebral Tethering is a safe and feasible method of anterior approach surgery for spinal deformity in pediatric idiopathic scoliosis.

Condition or disease Intervention/treatment Phase
Idiopathic Scoliosis Device: Anterior Vertebral Tether Not Applicable

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
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 : July 12, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Anterior Vertebral Tethering
Subjects receiving Anterior Vertebral Tethering intervention.
Device: Anterior Vertebral Tether
Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years after last subject's device implantation ]
    Intra-operative 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. Comparison of Pre-Operative and Post-Operative 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.

  2. Comparison of Pre-Operative and Post-Operative SRS 30 Scores [ Time Frame: 2 years after last subject's device implantation ]
    The SRS 30 questionnaire will be administered at pre-operative and post-operative time points. The results of the questionnaire will be used for pre-operative and post-operative comparative analysis of device related outcomes.



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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 curve of greater than or equal to 35 degrees and less than or equal to 60 degrees
  5. Lumbar curve less than 35 degrees
  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 subject has not had any previous surgery for this, and no surgery is planned in the future

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 syndrome or neurofibromatosis
  6. Sanders bone age greater than 4
  7. Thoracic curve less than 35 degrees or greater than 60 degrees
  8. Lumbar curve greater than or equal to 35 degrees
  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): NCT03194568


Contacts
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Contact: Catherine Qiu, MS 267-426-5433 qiuc@email.chop.edu
Contact: Divya Talwar, MPH, PhDc 215-590-7841 talward@email.chop.edu

Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Patrick Cahill, MD
Investigators
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Principal Investigator: Patrick Cahill, MD Children's Hospital of Philadelphia

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Responsible Party: Patrick Cahill, MD, Attending Orthopaedic Surgeon, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03194568     History of Changes
Other Study ID Numbers: 17-013694
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 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: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Patrick Cahill, MD, Children's Hospital of Philadelphia:
Scoliosis
Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases