Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL) in Patients Undergoing Long Segment Deformity Surgery: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Quality of Life as measured by Visual Analog Scale (VAS)
研究概览
简要总结
This study is being done to assess the impact of arm length and abdominal (belly) width on patient performance of daily self-care activities following multiple level spinal fusions. The study will also assess if the number of levels operated on in the spinal fusion procedure affects your ability to perform Activities of Daily Living (ADL) and how long after surgery do the difficulties/limitations persist.
详细描述
This is a prospective, single-center study of adult patients undergoing long segment spinal fusions to the pelvis (>5 levels).
Health Related Quality of Life Outcome (HRQOL) consisting of the Oswestry Disability Index (ODI), Visual Analog Scale, EQ-5D, Scoliosis Research Society-22 and 30 (SRS-22 and SRS-30) and the Lumbar Stiffness Disability Index (LSDI) will be collected preoperatively, 6 weeks, 3 months, 6 months, 12 and 24 months. All measures will be collected during clinic visits.
Primary and secondary objectives The primary objective is to determine the impact of body habitus on postoperative ADLs in patients undergoing long segment spinal fusions.
The secondary objective will be to determine if the number of levels of fusions impact the ability to perform ADLs and to study how long after surgery do the difficulties/limitations persist.
Study procedures Enrolled subjects meeting eligibility criteria and provide consent will be approached by the study coordinator and explained the purpose of the study, risks and benefits to participation, and queried about their interest in participation. Patients consenting to the study will have the following measurements performed by the clinician with an evaluation prior to surgery, during their 6 week, 3 month, 6 month, 12 and 24 month postoperative visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Adults18 to 80 years old
- •Spinal fusion surgery involving thoracolumbar spine > 5 levels
- •Ability to stand to obtain arm span, abdominal girth and ability to bend at the waist to obtain measurement
排除标准
- •Patients who are incarcerated, paraplegic or unable to return for follow-up visits
- •Patients with prior lumbar fusions at the indicated levels for surgery
- •Spinal fusion surgery involving thoracolumbar < 5 levels
- •Patients who already have lumbopelvic fixation with iliac screws
结局指标
主要结局
Change in Quality of Life as measured by Visual Analog Scale (VAS)
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
4 question survey that rates pain
Change in Quality of Life as measured by Scoliosis Research Society (SRS) Form
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
22 or 30 question survey that rates scoliosis
Change in Quality of Life as measured by Oswestry Disability Index (ODI)
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
10 question survey that rates disability from low, moderate, to severe disability
Change in Quality of Life as measured by Lumbar Stiffness Disability Index (LSDI) Form
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Survey that rates lumbar stiffness
Change in Quality of Life as measured by EQ-5D
时间窗: Baseline, 6 weeks, 3 months, 6 months, 12 and 24 months
Survey that looks at 5 different components activities of daily living
次要结局
未报告次要终点