Vertebral Body Tethering Treatment for Idiopathic Scoliosis (NCT03802656) | Clinical Trial Compass
TerminatedNot Applicable
Vertebral Body Tethering Treatment for Idiopathic Scoliosis
Stopped: Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.
United States2 participantsStarted 2019-06-24
Plain-language summary
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
Who can participate
Age range8 Years – 16 Years
SexALL
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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
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
What they're measuring
1
Safety: Incidence of Treatment-Emergent Adverse Events
Timeframe: 2 years after last subject's device implantation