A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in Bone Mineral Density as collected using DEXA scan
研究概览
简要总结
The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •US Military veteran with transfemoral amputation that is not a result of dysvascular disease
- •Has used or is using a "socket suspension technology" prosthesis
- •Use of non-propulsive, passive microprocessor-regulated devices
- •Agrees not to participate in high levels of physical activity while in the study
- •Subject meets anatomical and eligibility criteria for the investigational device
排除标准
- •Currently on active military duty
- •More than 1 limb amputated
- •Has insulin dependent or adult onset diabetes
- •Recent tobacco use
研究组 & 干预措施
TREATMENT
干预措施: Percutaneous Osseintegrated Prosthesis (Device)
结局指标
主要结局
Changes in Bone Mineral Density as collected using DEXA scan
时间窗: 1 year
Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant
时间窗: 1 year
Changes in implant exit site using Modified Holgers Skin Metric
时间窗: 1 yr
Analyze measurable changes in the stoma punch
时间窗: 1 year
Analyze changes of walking and standing
时间窗: 1 year
Three dimensional motion capture of walking and standing through a calibration volume that contains force plates
Analyze changes in metabolic efficiency
时间窗: 1 year
Measure CO2 and O2 exhaled, total energy cost for walking at slow, normal, fast; self-selected and/or fixed speeds while wearing a two-way valve.
Analyze changes in 6 minute walk test
时间窗: 1 year
Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function
时间窗: 1 yr
Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test
时间窗: 1 year
Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions
时间窗: 1 yr
Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)
时间窗: 1 yr
Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting
时间窗: 1 yr
Assess changes in Donning and Doffing prosthetic time
时间窗: 1 year
Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions
时间窗: 1 yr
Changes in at-home prosthetic usage using StepWatch activity monitor
时间窗: 1 yr
次要结局
未报告次要终点