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| Name | Class |
|---|---|
| Otto Bock Healthcare | INDUSTRY |
| Florida High Tech Corridor Council | OTHER |
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The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic knee 1 (Otto Bock C-Leg) | Active Comparator | This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics). |
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| Prosthetic knee 2 (Otto Bock Genium) | Active Comparator | This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance) |
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| Non-amputee controls | No Intervention | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otto Bock C-Leg | Device | Amputees' preferred prosthetic knee. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 75 Meter Self Selected Walking Test | Time to Complete a 75 meter walking distance. | 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. |
| Physical Functional Performance (Continuous Scale; 10-items) | Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function. | Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Balance and Stability | Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform. | 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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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. 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 | Prosthetic Knee 1 Then Prosthetic Knee 2 | Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium). |
| FG001 | Prosthetic Knee 2 Then Prosthetic Knee 1 | Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg). |
| FG002 | Control (Non-amputees) | Non-amputee control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first. |
| BG001 | Non Amputee Control Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 75 Meter Self Selected Walking Test | Time to Complete a 75 meter walking distance. | Posted | Mean | Standard Deviation | seconds | 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 | Prosthetic Knee 1 | Otto Bock C-Leg: Amputees' preferred prosthetic knee. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Jason Highsmith | University of South Florida | 8139743806 | mhighsmi@health.usf.edu |
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| Otto Bock Genium |
| Device |
Study knee. |
|
| Prosthesis Evaluation Questionnaire: Utility Score. | The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response). | 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. |
non-amputee healty controls |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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healthy, non-amputee controls
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| Secondary | Balance and Stability | Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform. | Posted | Mean | Standard Deviation | scores on a scale | 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. |
|
|
|
| Secondary | Prosthesis Evaluation Questionnaire: Utility Score. | The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response). | Posted | Median | Full Range | score on a scale | 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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|
| Primary | Physical Functional Performance (Continuous Scale; 10-items) | Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function. | Posted | Mean | Standard Deviation | scores on a scale | Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete. |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Prosthetic Knee 2 | Otto Bock Genium: Study knee. | 0 | 20 | 0 | 20 |
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