Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis

NCT03194568 | Completed Results DMC FDA Device

• 1 other identifier: 17-013694
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Scoliosis

Keywords

Scoliosis; Idiopathic Scoliosis; Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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".

  up to 2 years

Secondary Outcomes (2)

• Comparison of Pre-Operative and Post-Operative Cobb Angle

  up to 2 years

• Comparison of Pre-Operative and Post-Operative SRS 30 Scores

  up to 2 years

Study Arms (1)

Anterior Vertebral Tethering

EXPERIMENTAL

Subjects receiving Anterior Vertebral Tethering intervention.

Device: Anterior Vertebral Tether

Interventions

Anterior Vertebral Tether DEVICE

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

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

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 syndrome or neurofibromatosis
• Sanders bone age greater than 4
• Thoracic curve less than 35 degrees or greater than 60 degrees
• Lumbar curve greater than or equal to 35 degrees
• 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

• Patrick Cahill, MD: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Patrick Cahill
• Organization: Children's Hospital of Philadelphia

cahillp1@chop.edu

2155901000

Study Officials

• Patrick Cahill, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 INVESTIGATOR
• PI Title: Attending Orthopaedic Surgeon

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 21, 2017
• Study Start: July 12, 2017
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)