Lower Limb Amputation
Conditions
Keywords
Amputee
Brief summary
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.
Detailed description
Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.
Interventions
DEVICEConventional Prosthetic Transfemoral Socket System
Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
DEVICENovel Prosthetic transfemoral socket system
Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension
Sponsors
Ohio State University
Ohio Willow Wood
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Consenting Adult * Unilateral transfemoral amputee * Currently suing a liner with prosthesis * Uses a prosthesis to ambulate * Ability to read, write, and understand English * Available during regular business hours for appointments
Exclusion criteria
* Impaired contra lateral leg * Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.) * Diagnosis of renal failure * Smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laser Doppler flowmetry tissue perfusion values | 1 month | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laser speckle flowmetry tissue perfusion values | 1 month | Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month |
| Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) | 1 month | Change from baseline in hyperspectral imaging StO2% at 1 month |
| Trans-Epidermal Water Loss values | 1 month | Change from baseline in trans-epidermal water loss values at 1 month |
| Elasticity (cutometry) values | 1 month | Change from baseline in elasticity values at 1 month |
| Torsional Ballistometry values | 1 month | Change from baseline in torsional ballistometry values at 1 month |
| Surface electrical capacitance values | 1 month | Change from baseline in surface electrical capacitance values at 1 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature values | 1 month | Change from baseline in skin temperature values at 1 month |
| Prosthesis evaluation questionnaire (PEQ) | 1 month | Change from baseline in prosthesis evaluation response at 1 month |
Countries
United States
Contacts
Primary ContactRyan Schroeder
Outcome results
None listed