Vertebral Body Tethering Treatment for Idiopathic Scoliosis

Sponsor

Lawrence Haber (Other)

Overall Status

Recruiting

CT.gov ID

NCT03802656

Collaborator

(none)

Enrollment

Location

Arm

67.3

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Disease Adolescent Idiopathic Scoliosis Juvenile; Scoliosis	Device: Anterior Vertebral Body Tethering	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Jun 24, 2019

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anterior Vertebral Body Tethering Subjects who will be undergoing the anterior vertebral body tethering surgery.	Device: Anterior Vertebral Body Tethering Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.

Arm

Intervention/Treatment

Experimental: Anterior Vertebral Body Tethering

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

Device: Anterior Vertebral Body Tethering

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

Outcome Measures

Primary Outcome Measures

Safety: Incidence of Treatment-Emergent Adverse Events [2 years after last subject's device implantation]
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".

Secondary Outcome Measures

Feasibility: Incidence of Successfully Implanted Tether Devices [2 years after last subject's device implantation]
The feasibility of the vertebral body tethering device will analyzed based on successful implantation of the device. Implantation will be considered a failure if the device breaks/loosens after implantation, or if it overcorrects the spinal curve.
Efficacy: Comparison of Preoperative and Postoperative Cobb Angle [2 years after last subject's device implantation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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