Utility of Postoperative Bracing: A Single-institution, Randomized-control Trial Comparing Brace to No-brace for Patients Undergoing Long-segment Fusion for Spinal Deformity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Oswestry Disability Index (ODI) score
研究概览
简要总结
The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity.
If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment.
Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The principal investigator's new or returning patients
- •Adults 18 to 80 years of old
- •Undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity
排除标准
- •Patients who are undergoing a spinal fusion for other reasons besides deformity
- •Patients who are unable to provide consent or fill out survey questionnaires
- •Patients who have brace-prohibitive body habitus
- •Patients who are unable to obtain standing AP and lateral 3-foot standing scoliosis x-rays
结局指标
主要结局
Change in Oswestry Disability Index (ODI) score
时间窗: Baseline, 3 months, 6 months, 12 months and 24 months
Scores from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability.
次要结局
- Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)(Baseline, 3 months, 6 months, 12 months and 24 months)
- Change in Visual Analogue Scale (VAS)(Baseline, 3 months, 6 months, 12 months and 24 months)