Evaluation of a Novel Transfemoral Prosthetic Socket System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-09-30

Brief Summary

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The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.

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Detailed Description

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Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

Conditions

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Lower Limb Amputation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Conventional TF Socket System

Conventional Prosthetic Transfemoral Socket System

Group Type ACTIVE_COMPARATOR

Conventional Prosthetic Transfemoral Socket System

Intervention Type DEVICE

Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket

Novel TF Socket System

Novel Prosthetic Transfemoral Socket System

Group Type EXPERIMENTAL

Novel Prosthetic transfemoral socket system

Intervention Type DEVICE

Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

Interventions

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Conventional Prosthetic Transfemoral Socket System

Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket

Intervention Type DEVICE

Novel Prosthetic transfemoral socket system

Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

Intervention Type DEVICE

Other Intervention Names

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Ischial Containment Pin Transfemoral Socket Suction Transfemoroal Socket Above the knee (AK) socket

Eligibility Criteria

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Inclusion Criteria

* Consenting Adult
* Unilateral transfemoral amputee
* Currently suing a liner with prosthesis
* Uses a prosthesis to ambulate
* Ability to read, write, and understand English
* Available during regular business hours for appointments

Exclusion Criteria

* Impaired contra lateral leg
* Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
* Diagnosis of renal failure
* Smoker

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes