NCT04119284

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

September 27, 2019

Results QC Date

November 22, 2024

Last Update Submit

January 9, 2025

Conditions

Idiopathic Adolescent Scoliosis

Keywords

scoliosisVertebral Body TetheringcurveShah

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cobb Angle in Degrees

    The difference between Cobb angles measured prior to surgery and 2 years past surgery.

Study Arms (1)

Anterior Vertebral Tethering

EXPERIMENTAL

Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia.

Device: Anterior body tether (ABT)

Interventions

Anterior body tether (ABT)DEVICE

To insert the ABT in patients to correct AIS.

Also known as: Reflect/Transition™ Stabilization System Polyethylene terephthalate (PET) cord
Anterior Vertebral Tethering

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
Suken Shah, MD, Orthopedics Department Chair
Organization
Nemours Hospital for Children
suken.shah@nemours.org
3025472557

Study Officials

  • Suken Shah, MD

    Nemours-AIDHC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 8, 2019

Study Start

September 1, 2019

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

January 13, 2025

Results First Posted

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Informed Consent Form Access

Locations

US(1)