Safety Outcomes of Vertebral Body Tethering Technique

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.

Study Overview

• Status: Suspended
• Conditions: Idiopathic Adolescent Scoliosis
• Intervention / Treatment: Device: Anterior body tether (ABT)

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petya Yorgova, MS; Phone Number: 3026515920; Email: petya.yorgova@nemours.org
• Study Contact Backup: Name: Geraldine Neiss, Ph.D.; Phone Number: 3026516518; Email: geraldine.neiss@nemours.org

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterior Vertebral Tethering; Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia.	Device: Anterior body tether (ABT); To insert the ABT in patients to correct AIS.; Other Names: Reflect/Transition™ Stabilization System Polyethylene terephthalate (PET) cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cobb angle in degrees	The difference be between pre and post-operative Cobb angle measurements.	Cobb angle will be measured prior to surgery, at 6 moths, 1 year and 2 years past surgery.

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Suken Shah, MD, Nemours-AIDHC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: scoliosis; Vertebral Body Tethering; curve; Shah
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Free Radical Scavengers; Terephthalic acid
• Other Study ID Numbers: 1365311; G180238 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Informed Consent Form
   Information comments: The Informed consent form can be obtained while the patient is seen for scoliosis at Nemours-AIDHC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes