Status:
TERMINATED
Vertebral Body Tethering Treatment for Idiopathic Scoliosis
Lead Sponsor:
Ochsner Health System
Conditions:
Scoliosis
Spinal Curvatures
Eligibility:
All Genders
8-16 years
Phase:
NA
Brief Summary
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
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 underl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03802656
Start Date
June 24 2019
End Date
December 12 2019
Last Update
April 12 2023
Active Locations (1)
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1
Ochsner Health System- Jefferson Hwy
New Orleans, Louisiana, United States, 70121