Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility

Completed · Not applicable

Conditions studied: Transfemoral Amputation

In brief

The objective of this trial is to assess use and benefits of the subischial socket for persons with transfemoral amputation and lower mobility levels. Specifically, the investigators will evaluate whether the subischial socket improves comfort, socket wear time, mobility, participation, quality of life and satisfaction with device than the standard-of-care ischial containment socket.

Key facts

Study ID

NCT05662982

Run by

University of Washington

People needed

84

Starts

2023-03-01

Expected to finish

2025-11-30

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Speak and read English;
• Provision of signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• All sexes and genders age 18 years and older;
• Have a unilateral transfemoral or knee disarticulation amputation and have used a prosthesis for 1 year or more;
• Be classified by their prosthetist as being a Medicare Functional Classification Level of K2 (limited community ambulator);
• Have never worn a sub-ischial socket;
• Current IC socket and prosthesis must be well fitting and maintained; current socket must have pelvic weightbearing and/or containment;
• Participant has no plans to change the knee or foot in the next 10 months;
• Willingness to adhere to the monitoring and new socket regimen;
• Have sufficient upper limb function to don liner and change sensors;
• Access to necessary resources for participating in the study (i.e., computer, smartphone, internet access, telephone):
• Be a Veteran (VA site only).
• Exclusion Criteria (intervention group only):
• Have a femoral length <5 inches;
• Have a known silicone allergy;
• Are unable to don or tolerate wearing a compressive liner;
• Loss of metatarsal heads on contralateral limb;
• Active malignancy;
• Pregnancy;
• Polytrauma that affects functional ability beyond that of a unilateral transfemoral amputation.

Where it is running

• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States
• Hanger Institute for Clinical Research and Education — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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