Status:
TERMINATED
Safety Outcomes of Vertebral Body Tethering Technique
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Idiopathic Adolescent Scoliosis
Eligibility:
All Genders
8-16 years
Phase:
NA
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 scolio...
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 ...
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 curve of greater than or equal to 35 degrees and less than or equal to 60 degrees
- Lumbar curve less than 35 degrees
- 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 subject has not had any previous surgery for this, and no surgery is planned in the future
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 syndrome or neurofibromatosis
- Sanders bone age greater than 4
- Thoracic curve less than 35 degrees or greater than 60 degrees
- Lumbar curve greater than or equal to 35 degrees
- 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 :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04119284
Start Date
September 1 2019
End Date
December 15 2023
Last Update
January 13 2025
Active Locations (1)
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1
Nemours Hospital for Children
Wilmington, Delaware, United States, 19803