A Comparative Assessment of Transfemoral Prosthetic Sockets

NCT ID: NCT04038580

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2024-07-01

Brief Summary

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

Detailed Description

The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. Thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. This data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) Are individual characteristics associated with benefits of specific socket designs?

Conditions

Amputation; Amputation; Traumatic, Leg, Lower

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Prescribed Laminated Socket

In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.

Group Type: SHAM_COMPARATOR

Laminated Socket

Intervention Type: DEVICE

This is the currently prescribed socket the participant normally wears.

Adjustable Sockets

In this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket.

Group Type: EXPERIMENTAL

Quatro

Intervention Type: DEVICE

The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Infinite Socket

Intervention Type: DEVICE

The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

CJ Socket

Intervention Type: DEVICE

The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Interventions

Laminated Socket

This is the currently prescribed socket the participant normally wears.

Intervention Type: DEVICE

Quatro

The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Intervention Type: DEVICE

Infinite Socket

The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Intervention Type: DEVICE

CJ Socket

The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Unilateral lower-limb amputation
• Six months of independent ambulation
• Own and regularly wear a prosthesis with socket
• Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "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

• Pathology or injury of the intact limb
• Medication that affects their ability to walk
• Neurologic or cardiovascular disease
• Significant vision problems
• Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Deanna H Gates

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna H Gates, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Rosalind Franklin University

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00140733

Identifier Type: -

Identifier Source: org_study_id