Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Safety: Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 8 to 16 years old at time of enrollment (inclusive)
- •Diagnosis of idiopathic scoliosis
- •Sanders bone age of less than or equal to 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
- •Lenke classification of 1, 2, 3, 5, or 6
- •Patient has already been identified for and recommended to have surgical intervention
- •Spina bifida occulta is permitted
- •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
- •Completed standard-of-care procedures as outlined in Section 5
排除标准
- •Pregnancy (current)
- •Prior spinal or chest surgery
- •MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- •Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- •Associated syndrome, including Marfan Disease or Neurofibromatosis
- •Sanders bone age greater than 4
- •Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees
- •Compensatory curve greater than 35 degrees without intent to treat surgically
- •Unable or unwilling to firmly commit to returning for required follow-up visits
- •Investigator judgement that the subject/family may not be a candidate for the intervention
结局指标
主要结局
Safety: Incidence of Treatment-Emergent Adverse Events
时间窗: 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".
次要结局
- Feasibility: Incidence of Successfully Implanted Tether Devices(2 years after last subject's device implantation)
- Efficacy: Comparison of Preoperative and Postoperative Cobb Angle(2 years after last subject's device implantation)