Vertebral Body Tethering Treatment for Idiopathic Scoliosis

NCT03802656 | Terminated DMC FDA Device

• 1 other identifier: VBT120718
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Disease; Adolescent Idiopathic Scoliosis; Juvenile; Scoliosis

Keywords

Scoliosis; Idiopathic Scoliosis; Adolescent Idiopathic Scoliosis; Vertebral Body Tethering; growth modulation spine; spine; juvenile scoliosis

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of Treatment-Emergent Adverse Events

  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".

  2 years after last subject's device implantation

Secondary Outcomes (2)

• Feasibility: Incidence of Successfully Implanted Tether Devices

  2 years after last subject's device implantation

• Efficacy: Comparison of Preoperative and Postoperative Cobb Angle

  2 years after last subject's device implantation

Study Arms (1)

Anterior Vertebral Body Tethering

EXPERIMENTAL

Subjects who will be undergoing the anterior vertebral body tethering surgery.

Device: Anterior Vertebral Body Tethering

Interventions

Anterior Vertebral Body Tethering DEVICE

Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.

Anterior Vertebral Body Tethering

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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
• Lenke classification of 1, 2, 3, 5, or 6
• 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 patient has not had any previous surgery for this, and no surgery is planned in the future
• Completed standard-of-care procedures as outlined in Section 5

You may not qualify if:

• 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 Disease or Neurofibromatosis
• Sanders bone age greater than 4
• Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees
• Compensatory curve greater than 35 degrees without intent to treat surgically
• 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

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Health System- Jefferson Hwy

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Lawrence Haber, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: June 24, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)