NCT03609138撤回不适用
The O-arm Assessment of Vertebral Movement Pre and Post Correction Using ST2R Technique
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients
研究概览
简要总结
The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.
详细描述
Visits include the pre-operative visit, 1 and 2 year follow-up visits. Participation includes answering questions and filling out questionnaires. There are no immediate benefits by joining this study, but could potentially help define better techniques for the future spine surgeries. The risks involved in this study are minimal and there are no alternatives to this study.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology
- •Age between 10 and 21
- •Lenke Type 1 curve
- •Consent and Assent to participate in the study
排除标准
- •Age superior to 21 years
- •Spinal deformities other than Lenke 1 type
- •Use of implant other than those from the PASS LP system or sublaminar bands
- •Neuromuscular or degenerative scoliosis
- •Spinal cord abnormalities with any neurologic symptoms or signs
- •Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
- •Primary muscle diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, Cerebral palsy, or Spina bidifa, Neurofibroma)
- •Primary abnormalities of bones (e.g. osteogenesis imperfect)
- •Congenital Scoliosis
- •Scoliosis requiring anterior release
- •Previous spinal surgery
- •Absence of required preoperative data (diagnosis, consent...)
结局指标
主要结局
Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients
时间窗: 4 years
次要结局
- Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data(4 years)
研究者
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