A Comparative Assessment of Transfemoral Prosthetic Sockets

University of Michigan

Status: Completed

Conditions: Amputation; Traumatic, Leg, Lower; Amputation

Treatments: Device: CJ Socket; Device: Infinite Socket; Device: Laminated Socket; Device: Quatro

Study type: Interventional

Funder types: Other

Identifiers

NCT04038580

HUM00140733

Details and patient eligibility

About

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

Full 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?

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Prescribed Laminated Socket

Sham Comparator group

Description:

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

Treatment:

Device: Laminated Socket

Adjustable Sockets

Experimental group

Description:

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.

Treatment:

Device: Quatro

Device: Infinite Socket

Device: CJ Socket