NCT05190354已完成不适用
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Medical Creations, Inc.4 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2021年11月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- User Preference of the Xtremity Socket - Activity
研究概览
简要总结
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 19 years old
- •Unilateral or bilateral transtibial amputation
- •Subject has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
- •Currently using a standard carbon fiber or high temperature thermoplastic prosthetic socket.
- •Residual limb is between 26-34 cm circumference with a liner (when measured 4cm proximal to distal end)
- •Subject is eligible for standard carbon fiber or high temperature thermoplastic prosthetic socket if necessary.
- •Must be able to ambulate at least 100 yards with or without an assistive device.
- •Must be able to don and doff a prosthesis independently.
- •Estimated life expectancy > 1 year
排除标准
- •Amputation < 6 months prior to enrollment
- •Residual limb less than (<) 26cm and greater than (>) 34cm circumference at the distal end.
- •Body weight greater than (>) 275lbs.
- •Syme's amputations or total limb length over 30cm
- •Some bulbous or irregular limb shapes
- •Build height and circumference limitations
- •Wounds or skin issues that preclude normal fit
- •Unusual alignment of the socket or foot
- •Alignment outside the capability of the Xtremity System.
- •Planned for any major surgery within 6 months of enrollment.
- •Subject is pregnant or breastfeeding
- •Subject is incarcerated.
- •Subject anticipates that the socket will frequently be subject to temperatures greater than 110 degrees F while in their possession.
- •Subject anticipates that the socket will frequently be subject to direct sunlight
- •Limb circumference at the mid-patella tendon exceeds the maximum circumference (see sizing chart in the instructions for use)
- •Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
- •Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre and post-treatment.
结局指标
主要结局
User Preference of the Xtremity Socket - Activity
时间窗: 21 Days
Rate of device success measured by activity level ranked low activity to high activity (1-10)
User Preference of the Xtremity Socket - Socket Comfort Score
时间窗: 21 Days
Rate of device success measured by Socket Comfort Score
User Preference of the Xtremity Socket - Achievement of durability
时间窗: 21 days
Device success defined as rate of achieving durability
User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire
时间窗: 21 Days
Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire
次要结局
- Benefits to prosthetist - Material Consumption(21 days)
- Benefits to prosthetist - Skill(21 days)
- Benefits to Patient - Mobility(21 days)
- Benefits to patient - Number of Visits(21 days)
- Benefits to prosthetist - Casting Time(21 days)
- Benefits to prosthetist - Adjustability(21 days)
- Benefits to Patient - Cosmesis(21 days)
- Benefits to prosthetist - Material Waste(21 days)
- Device Safety - Composite of Device Related Adverse Events(21 days)
- Benefits to prosthetist - Resources(21 days)
研究者
研究点 (4)
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