Vertebral Body Tethering Treatment for Idiopathic Scoliosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 8 Years - 16 Years
Gender All
More Inclusion & Exclusion 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 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 5. Lenke classification of 1, 2, 3, 5, or 6 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 patient has not had any previous surgery for this, and no surgery is planned in the future 9. Completed standard-of-care procedures as outlined in Section 5

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 Disease or Neurofibromatosis 6. Sanders bone age greater than 4 7. Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees 8. Compensatory curve greater than 35 degrees without intent to treat surgically 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03802656
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lawrence Haber
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lawrence Haber, MD
Principal Investigator Affiliation Ochsner Health System
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Diseases, Musculoskeletal Disease, Adolescent Idiopathic Scoliosis, Juvenile; Scoliosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Anterior Vertebral Body Tethering

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

Interventions

Device: - Anterior Vertebral Body Tethering

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ochsner Health System- Jefferson Hwy, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Health System- Jefferson Hwy

New Orleans, Louisiana, 70121

Site Contact

Lawrence Haber, MD

[email protected]

504-842-8705