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| ID | Type | Description | Link |
|---|---|---|---|
| VA118-12-C-0038 | Other Grant/Funding Number | Veterans Affairs Innovation Initiative |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional TF Socket System | Active Comparator | Conventional Prosthetic Transfemoral Socket System |
|
| Novel TF Socket System | Experimental | Novel Prosthetic Transfemoral Socket System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Prosthetic Transfemoral Socket System | Device | Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket |
| Measure | Description | Time Frame |
|---|---|---|
| Laser Doppler flowmetry tissue perfusion values | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Laser speckle flowmetry tissue perfusion values | Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month | 1 month |
| Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) |
| Measure | Description | Time Frame |
|---|---|---|
| Skin temperature values | Change from baseline in skin temperature values at 1 month | 1 month |
| Prosthesis evaluation questionnaire (PEQ) | Change from baseline in prosthesis evaluation response at 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Schroeder | Contact | 740-869-3377 | ryans@owwco.com |
| Name | Affiliation | Role |
|---|---|---|
| Gayle Gordillo, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Davis Heart and Lung Research Institute | Recruiting | Columbus | Ohio | 43210 | United States |
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|
| Novel Prosthetic transfemoral socket system | Device | Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension |
|
Change from baseline in hyperspectral imaging StO2% at 1 month
| 1 month |
| Trans-Epidermal Water Loss values | Change from baseline in trans-epidermal water loss values at 1 month | 1 month |
| Surface electrical capacitance values | Change from baseline in surface electrical capacitance values at 1 month | 1 month |
| Elasticity (cutometry) values | Change from baseline in elasticity values at 1 month | 1 month |
| Torsional Ballistometry values | Change from baseline in torsional ballistometry values at 1 month | 1 month |
| 1 month |
| The Ohio Willow Wood Company | Recruiting | Mount Sterling | Ohio | 43143 | United States |
|