Clinical trial NCT04119284: Safety Outcomes of Vertebral Body Tethering Technique
Official title: Safety and Efficacy of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Adolescent Scoliosis
Keywords: scoliosis
Vertebral Body Tethering
curve
Shah
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 scoliosis.

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 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 Adolescent Idiopathic Scoliosis(AIS) 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 efficacy of Anterior Vertebral Body Tethering to avoid curve progression to more than 50 degrees.

Eligibility 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 curve of greater than or equal to 35 degrees and less than or equal to 60 degrees
5. Lumbar curve less than 35 degrees
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 subject has not had any previous surgery for this, and no surgery is planned in the future

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 syndrome or neurofibromatosis
6. Sanders bone age greater than 4
7. Thoracic curve less than 35 degrees or greater than 60 degrees
8. Lumbar curve greater than or equal to 35 degrees
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

Primary outcomes:
measure: Number of Adverse Events After the Procedure
timeFrame: 2 years after the surgery
Secondary outcomes:
measure: Cobb Angle in Degrees
timeFrame: The difference between Cobb angles measured prior to surgery and 2 years past surgery.
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Hospital for Children
state: Delaware
Study officials:
affiliation: Nemours-AIDHC
name: Suken Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: