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临床试验/NCT00117793
NCT00117793已完成不适用

Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Activity Level

研究概览

简要总结

The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system.

The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.

详细描述

A proper fitting prosthetic socket provides the amputee with a comfortable system allowing them to pursue many of their desired vocational and recreational goals. Unfortunately, many amputees live with an ill-fitting socket and can experience limb pistoning within the socket, which in turn may result in skin irritation, tissue breakdown, discomfort, and a reduction in activity. One of the key factors affecting fit is intraday residual limb volume changes. For an amputee with dysvascular conditions, the implications of a poor fitting socket are exacerbated by poor circulation, reduced healing potential and the compressive forces exerted by their prosthesis.

Vacuum suspension systems may have the potential to alleviate these conditions for healthy and dysvascular amputees. The purported benefits of vacuum suspension systems include, but are not limited to: improved suspension (reduction in the amount of pistoning), maintenance of limb volume throughout the day, and increased tissue oxygenation to the residual limb.

Our first objective is to characterize performance, as related to socket fit, of a vacuum suspension system using objective and subjective measures. We will do this by conducting a within-subject experiment to measure pistoning in three dimensions while walking, overall and regional changes in limb volume before and after a thirty-minute treadmill walk, mobility (step counts) and the perception of socket fit (questionnaire) as a function of prosthetic prescription (vacuum suspension system vs. total surface bearing suction socket).

Our second objective is to determine the effect of pressures within a prosthetic socket on residual limb transcutaneous oxygen tension (tcpO2) levels. We will conduct laboratory-based, in situ testing to determine how the transcutaneous oxygen tension levels, at six sites on the residual limb, respond to pressures simulating those within a vacuum suspension system and a total surface bearing suction socket.

The proposed research will allow us to understand how suspension systems influence prosthetic socket fit and residual limb tissue health and to formulate a knowledge base on two suspension systems providing prosthetists and clinicians the objective data to make better prescription decisions. In addition, the methods utilized in this study (e.g., a residual limb limb volume scanner and assessing dynamic pistoning) can be used to study current and novel suspension systems, liners, and prosthetic socket designs to provide a standard for comparison.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Over 18 and less than 70 years of age,
  • •Have a below knee amputation involving only one side,
  • •If the cause of amputation was for traumatic reasons and do not have diabetes or a vascular condition, the amputation must have occurred at least six months ago and the potential subject must have worn a prosthesis for at least four months,
  • •If the cause of amputation was for diabetes or vascular reasons, the potential subject must have been fit with a prosthesis and have worn it for at least one year,
  • •Wear the prosthesis for at least 6 hours a day,
  • •Able to walk without a cane, crutches, or a walker,
  • •Are moderately active enough to walk at a steady pace for at least 30 minutes.

排除标准

  • •Have pain in legs or any condition that interferes with walking.
  • •Have an ulcer on the residual limb,
  • •If potential subject had an amputation because of a tumor or an infection, no longer have an active tumor or undergoing treatment for a tumor,
  • •Have fallen within the last 3 months.

研究组 & 干预措施

Arm 1

Active Comparator

Current clinical practice

干预措施: Total Surface Bearing Suction Socket (Device)

Arm 2

Experimental

Novel socket system

干预措施: Vacuum assisted socket system (Device)

结局指标

主要结局

Activity Level

时间窗: Two weeks

Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).

Limb Pistoning

时间窗: Measurements were taken after wearing the study prosthesis for three weeks

Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.

Limb Volume

时间窗: Measurements were taken after wearing the study prostheses for three weeks

次要结局

  • Residual Limb Health (PEQ Scale)(Measurements were taken after wearing the study prosthesis for four weeks)
  • Ambulation (PEQ Scale)(Measurements were taken after wearing the study prosthesis for four weeks)
  • Frustration (PEQ Scale)(Measurements were taken after wearing the study prosthesis for four weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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