Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility (NCT05662982) | Clinical Trial Compass
CompletedNot Applicable
Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility
United States84 participantsStarted 2023-03-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Change in Socket Comfort Score (SCS)
Timeframe: Change from week 12 to week 24 compared between Intervention and Reference Groups.