Safety Outcomes of Vertebral Body Tethering Technique

NCT ID: NCT04119284

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-12-15

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.

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.

Conditions

Idiopathic Adolescent Scoliosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anterior Vertebral Tethering

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

Group Type: EXPERIMENTAL

Anterior body tether (ABT)

Intervention Type: DEVICE

To insert the ABT in patients to correct AIS.

Interventions

Anterior body tether (ABT)

To insert the ABT in patients to correct AIS.

Intervention Type: DEVICE

Other Intervention Names

Reflect/Transition™ Stabilization System Polyethylene terephthalate (PET) cord

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Suken Shah

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suken Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours-AIDHC

Locations

Nemours Hospital for Children

Wilmington, Delaware, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: Informed Consent Form

The Informed consent form can be obtained while the patient is seen for scoliosis at Nemours-AIDHC.

View Document

Other Identifiers

G180238

Identifier Type: OTHER

Identifier Source: secondary_id

1365311

Identifier Type: -

Identifier Source: org_study_id