Thighplasty of Transfemoral Amputee Residual Limbs to Improve Prosthesis Fit and Patient Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.
研究概览
简要总结
The purpose of our study is to improve the fit and function of prosthetic sockets for above the knee amputees through the use of an outpatient thigh reduction surgical procedure.
详细描述
We will quantify the anatomical distribution of subcutaneous fat, muscle and bone in the residual limb of the transfemoral amputees with an MRI. We will measure the displacement of the socket wall relative to the femur under mechanical loading with x-ray. The functional mobility level of the subject with be quantified via standard clinical and bio mechanical tests. Perform a standard medial thighplasty with our without thigh liposuction. Characterize the post-surgical anatomy, compliance of the residual limb and function of the amputee subjects. After six months, repeat the MRI and xray and compare results. Subject will also complete a questionnaire regarding their views on the outcome of the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese transfemoral amputees with a BMI of at least
- •Mid to long residual limb, excessive adipose tissue in their residual limb
- •Community ambulators
- •Adults over the age of 18
排除标准
- •Amputation due to vascular disease or diabetes
- •Cognitive impairments that would interfere with the protocol or patient safety
- •Systemic disease that is not stable or would significantly increase the risk of complications with surgery
- •Chronic wounds
- •People who do not ambulate on a daily basis
- •Children under the age of 18.
结局指标
主要结局
Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.
时间窗: Pre surgery and 6 months post surgery
We will measure the compliance of their residual limb by the displacement of the socket wall relative to the femur under mechanical loading with X-ray. The subjects will adjust their foot placement, limb loading and muscle contractions to achieve up to 8 specified force/torque levels (as measured by a 6 degree-of-freedom load cell located in series with their pylon and socket), which correspond to forces and torques that are typical of over ground walking and standing postures and are scaled for their body weight. For each force/torque level, static X-ray scans of locations of the prosthetic socket wall and residual limb femur will be acquired.
次要结局
- Assess walking endurance(Pre surgery and 6 months post surgery)
- Assess balance stability(Pre surgery and 6 months post surgery)
研究者
Todd Kuiken
Director, Center for Bionic Medicine
Shirley Ryan AbilityLab