Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation (SocketFit)

VA Office of Research and Development

Status: Enrolling

Conditions: Transfemoral Amputation; Transtibial Amputation

Treatments: Device: Adjustable Quatro socket; Device: Conventional prosthetic socket

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT05989243

A3643-R

Details and patient eligibility

About

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Full description

The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The investigators will enroll up to 40 Veterans

  • 20 with unilateral transtibial amputation
  • 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old

• All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation

• Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator

Exclusion criteria

• Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)

Trial design

40 participants in 2 patient groups

Veterans with a transtibial amputation

Description:

20 Veterans with a transtibial amputation, 10 females and 10 males

Treatment:

Device: Conventional prosthetic socket

Device: Adjustable Quatro socket

Veterans with a transfemoral amputation

Description:

20 Veterans with a transfemoral amputation, 10 females and 10 males

Treatment:

Device: Conventional prosthetic socket

Device: Adjustable Quatro socket