Evaluation of a Novel Transfemoral Prosthetic Socket System

Ohio Willow Wood

Status: Unknown

Conditions: Lower Limb Amputation

Treatments: Device: Novel Prosthetic transfemoral socket system; Device: Conventional Prosthetic Transfemoral Socket System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01846845

VA-2012-Aim3

VA118-12-C-0038 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Conventional TF Socket System

Active Comparator group

Description:

Conventional Prosthetic Transfemoral Socket System

Treatment:

Device: Conventional Prosthetic Transfemoral Socket System

Novel TF Socket System

Experimental group

Description:

Novel Prosthetic Transfemoral Socket System

Treatment:

Device: Novel Prosthetic transfemoral socket system