Scoliosis Clinical Trial
Official title:
Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
Verified date | April 2023 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 12, 2019 |
Est. primary completion date | December 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 16 Years |
Eligibility | 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 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 5. Lenke classification of 1, 2, 3, 5, or 6 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 patient has not had any previous surgery for this, and no surgery is planned in the future 9. Completed standard-of-care procedures as outlined in Section 5 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 Disease or Neurofibromatosis 6. Sanders bone age greater than 4 7. Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees 8. Compensatory curve greater than 35 degrees without intent to treat surgically 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Health System- Jefferson Hwy | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Ochsner Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Incidence of Treatment-Emergent Adverse Events | Intraoperative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related". | 2 years after last subject's device implantation | |
Secondary | Feasibility: Incidence of Successfully Implanted Tether Devices | The feasibility of the vertebral body tethering device will analyzed based on successful implantation of the device. Implantation will be considered a failure if the device breaks/loosens after implantation, or if it overcorrects the spinal curve. | 2 years after last subject's device implantation | |
Secondary | Efficacy: Comparison of Preoperative and Postoperative Cobb Angle | The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine. | 2 years after last subject's device implantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Recruiting |
NCT05944393 -
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
|
N/A | |
Recruiting |
NCT05888038 -
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
|
N/A | |
Completed |
NCT02531945 -
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
|
N/A | |
Completed |
NCT02890654 -
Scoliosis and Quality of Life of Adolescents
|
||
Completed |
NCT02413788 -
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
|
N/A | |
Completed |
NCT02558985 -
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
|
||
Terminated |
NCT02134704 -
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
|
N/A | |
Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
Completed |
NCT02285621 -
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
|
N/A | |
Withdrawn |
NCT00768313 -
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
|
Phase 4 | |
Completed |
NCT00155545 -
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
|
Phase 1 | |
Completed |
NCT00154505 -
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
|
Phase 1 | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Completed |
NCT00273598 -
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
|
Phase 2 | |
Completed |
NCT03135665 -
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
|
N/A | |
Completed |
NCT06428864 -
Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
|
||
Recruiting |
NCT04423146 -
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
|
||
Completed |
NCT03814239 -
Blood and Fluid Management During Scoliosis Surgery
|
||
Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|