NCT01633931Unknown不适用
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in major scoliotic curve magnitude
研究概览
简要总结
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Adolescent Idiopathic Scoliosis
- •Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
- •Skeletally immature (Risser Sign 0, 1, 2, or 3)
- •In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
- •Age between 10 and 15
- •Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
- •Candidate for surgical implantation of spinal instrumentation
- •Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
- •Must sign informed consent to permit the use of personal health data
排除标准
- •Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
- •Patients who require an MRI following implantation
- •Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
- •Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- •History of previous surgical treatment for AIS
结局指标
主要结局
Change in major scoliotic curve magnitude
时间窗: Change from baseline to 36 months postoperative
Measured in degrees
Number and Types of Adverse Events
时间窗: Operative through 36 months postoperative
次要结局
- Radiographic evaluation coronal balance compared to baseline(Change from baseline to 36 months postoperative)
- Radiographic evaluation sagittal balance compared to baseline(Change from baseline to 36 months postoperative)
- Percent of patients indicated for surgical spine fusion(Change from baseline to 36 months postoperative)
- Comparison of Rib Hump prominence(Change from baseline to 36 months postoperative)
- Quality of life assessment via SRS-30 questionnaire(Change from baseline to 36 months postoperative)
- Expected vs. Actual Device Lengthening(All postoperative visits where lengthening is conducted)
研究者
研究点 (1)
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