Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis

Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Device: Anterior Vertebral Tether

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	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".	2 years after last subject's device implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Pre-Operative and Post-Operative Cobb Angle	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 years after last subject's device implantation
Comparison of Pre-Operative and Post-Operative SRS 30 Scores	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.	2 years after last subject's device implantation

Collaborators and Investigators

• Sponsor: Patrick Cahill, MD
• Investigators: Principal Investigator: Patrick Cahill, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2017
• Primary Completion (ACTUAL): January 26, 2022
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (ACTUAL): June 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Scoliosis; Adolescent Idiopathic Scoliosis; Idiopathic Scoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 17-013694

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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