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Not Yet Recruiting
NCT05662982
Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility
Conditions: Transfemoral Amputation
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: University of Washington
Location: United States
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.
Eligibility Criteria
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;Participant has no plans to change the knee or foot in the next 9 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.
Source: ClinicalTrials.gov (NCT05662982). StuddyBuddy aggregates publicly available trial information.