NCT04038580

A Comparative Assessment of Transfemoral Prosthetic Sockets

A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Laminated Socket	This is the currently prescribed socket the participant normally wears.
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.
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.
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.

Timeline

• Start date: 2019-08-15
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2019-07-31
• Last updated: 2025-09-29
• Results posted: 2025-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study