Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

Completed · Not applicable

Conditions studied: Amputation

In brief

The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.

Key facts

Study ID

NCT02773056

Run by

University of South Florida

People needed

15

Starts

2016-06-01

Expected to finish

2018-03-30

Last updated by the study team

2018-04-03

Who can join

Age: 18 and older, up to 44. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral above the knee amputees of non-dysvascular etiology
• 100-275 lbs
• ≥ 1 yr. of prosthetic experience
• Independent community ambulator
• Self-reported ability to walk for 20min consecutively

You may not qualify if…

• Above the knee amputees of dysvascular etiologies
• Body weight <100 or >275 lbs
• Does not speak English or Spanish
• Use of an assistive device (i.e. canes, walkers)
• Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
• Known skin issues
• Known cognitive impairment

Where it is running

• University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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