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| Name | Class |
|---|---|
| Southern Bone & Joint Specialists, P.A. | UNKNOWN |
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The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Prosthetic socket standard of care | Active Comparator |
| |
| Active Comparator: Prosthetic brimless socket | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care socket | Device | Amputees' preferred socket. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gait | Gait will be assessed in terms of biomechanics and spatiotemporal parameters. | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. |
| Balance and Stability | Balance and stability will be assessed for limits of stability and postural stability. | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. |
| Quality of Life | Validated surveys will be used to solicit participants' subjective experience and feedback. | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. |
| Socket Pressure | Pressure sensors are placed on the skin and measured. | 10 minutes after fitting with both sockets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Highsmith, PT,DPT,CP | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Prosthetic Socket (Ischial Containment) | In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition. |
| FG001 | Prosthetic Socket (Experimental): Brimless Socket | 5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control Condition: Ischial Containment |
| |||||||||||||
| Experimental Condition: Brimless |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Prosthetic Socket Standard of Care | This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity. |
| BG001 | Active Comparator: Prosthetic Brimless Socket |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gait | Gait will be assessed in terms of biomechanics and spatiotemporal parameters. | Not Posted | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. | ||||||||||||
| Primary | Balance and Stability | Balance and stability will be assessed for limits of stability and postural stability. | Not Posted | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vacuum Assisted Socket |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Highsmith | University of South Florida | 813-974-3806 | mhighsmi@health.usf.edu |
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| Prosthetic brimless socket | Device | Study socket |
|
| NOT COMPLETED |
|
This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | Quality of Life | Validated surveys will be used to solicit participants' subjective experience and feedback. | Not Posted | Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation. |
| Primary | Socket Pressure | Pressure sensors are placed on the skin and measured. | Posted | Mean | Standard Deviation | mm Hg | 10 minutes after fitting with both sockets |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Standard of Care Socket | 0 | 10 | 0 | 10 |
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