Vertebral Body Tethering Treatment for Idiopathic Scoliosis
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|ClinicalTrials.gov Identifier: NCT03802656|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Disease Adolescent Idiopathic Scoliosis Juvenile; Scoliosis||Device: Anterior Vertebral Body Tethering||Not Applicable|
Expanded Access : Lawrence Haber has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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 underlying etiologies and the etiology is used to classify the types of scoliosis. Idiopathic scoliosis is sub-classified in two ways: by age of onset and by magnitude of deformity. 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 scoliosis 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 feasibility of Anterior Vertebral Body Tethering to avoid curve progression to 50 degrees.
The study intervention is surgical orthopedic implantation of the Anterior Vertebral Tether Device, by way of thoracoscopic surgery under general anesthesia. The primary outcome measures include assessments of safety of the insertion procedure and of the device, as well as the secondary measure of feasibility by determining the ability to successfully implant the investigational device.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis|
|Actual Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2025|
Experimental: Anterior Vertebral Body Tethering
Subjects who will be undergoing the anterior vertebral body tethering surgery.
Device: Anterior Vertebral Body Tethering
Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
- Safety: Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years after last subject's device implantation ]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".
- Feasibility: Incidence of Successfully Implanted Tether Devices [ Time Frame: 2 years after last subject's device implantation ]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.
- Efficacy: Comparison of Preoperative and Postoperative Cobb Angle [ Time Frame: 2 years after last subject's device implantation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802656
|Contact: Lawrence Haber, MDfirstname.lastname@example.org|
|Contact: Anna Strahan, NPemail@example.com|
|United States, Louisiana|
|Ochsner Health System- Jefferson Hwy||Recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Lawrence Haber, MD firstname.lastname@example.org|
|Principal Investigator:||Lawrence Haber, MD||Ochsner Health System|