Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03194568|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Scoliosis||Device: Anterior Vertebral Tether||Not Applicable|
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 :||July 12, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2023|
Experimental: Anterior Vertebral Tethering
Subjects receiving Anterior Vertebral Tethering intervention.
Device: Anterior Vertebral Tether
Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years after last subject's device implantation ]Intra-operative 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".
- Comparison of Pre-Operative and Post-Operative 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.
- Comparison of Pre-Operative and Post-Operative SRS 30 Scores [ Time Frame: 2 years after last subject's device implantation ]The SRS 30 questionnaire will be administered at pre-operative and post-operative time points. The results of the questionnaire will be used for pre-operative and post-operative comparative analysis of device related outcomes.
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): NCT03194568
|Contact: Catherine Qiu, MSemail@example.com|
|Contact: Divya Talwar, MPH, PhDcfirstname.lastname@example.org|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Patrick Cahill, MD||Children's Hospital of Philadelphia|