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

University of South Florida15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Amputation

Interventions

Ischial Ramus Containment (IRC)DEVICE

Ischial Ramus Containment (IRC) is the standard of care socket

Dynamic Socket Ischial Ramus Containment (IRC)DEVICE

Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket

Sub-Ischial Interface (Sub-I)DEVICE

Sub-Ischial Interface (Sub-I) is a comparator study socket

Eligibility

Sex: ALLMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

Skin Temperature

Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed