Idiopathic Adolescent Scoliosis
Conditions
Keywords
scoliosis, Vertebral Body Tethering, curve, Shah
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.
Interventions
DEVICEAnterior body tether (ABT)
To insert the ABT in patients to correct AIS.
Sponsors
Nemours Children's Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events After the Procedure | 2 years after the surgery | We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections. Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases. The PI will determine if these events are related to the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cobb Angle in Degrees | The difference between Cobb angles measured prior to surgery and 2 years past surgery. | The difference between pre and post-operative Cobb angle measurements. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anterior Vertebral Tethering Anterior Vertebral Tether Vertebral body tethering done through anterior spine surgery under anesthesia.
Anterior body tether (ABT): To insert the ABT in patients to correct AIS. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Anterior Vertebral Tethering |
|---|---|
| Age, Continuous | 11.34 years |
| Cobb angle | 48.125 degree |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Adverse Events After the Procedure
We will look for any changes in neurological status, tether failure, implant reoperation, overcorrection and wound infections. Adverse events will be summarized by their severity and frequency and reported to IRB and Data Safety board on timely bases. The PI will determine if these events are related to the device.
Time frame: 2 years after the surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Vertebral Tethering | Number of Adverse Events After the Procedure | 8 Number of Tether failures |
Secondary
Cobb Angle in Degrees
The difference between pre and post-operative Cobb angle measurements.
Time frame: The difference between Cobb angles measured prior to surgery and 2 years past surgery.
Population: 8 patients completed the study. Their pre-operative main curve measurements (Cobb angles) were measured and summarized. The same measurements were obtained at the 2 years follow up visits. The data was summarized and the means difference with the standard deviation were reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anterior Vertebral Tethering | Cobb Angle in Degrees | 22.37 degrees | Standard Deviation 4.16 |