Other and Unspecified Complications of Amputation Stump
Conditions
Brief summary
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.
Interventions
DEVICEOtto Bock C-Leg
Amputees' preferred prosthetic knee.
DEVICEOtto Bock Genium
Study knee.
Sponsors
Otto Bock Healthcare
Florida High Tech Corridor Council
Jason Highsmith
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Unilateral transfemoral or knee-disarticulation amputee * 18 to 85 years of age * K3 (variable cadence and community) ambulators; * Current use of and experience with the C-Leg for at least 1 year * Ability to descend stairs and hills without caregiver and assistive devices * Be able to independently provide informed consent * Be willing to comply with study procedures.
Exclusion criteria
* History of chronic skin breakdown on the residual limb * Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking) * Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate * Unwillingness/inability to follow instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 75 Meter Self Selected Walking Test | 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. | Time to Complete a 75 meter walking distance. |
| Physical Functional Performance (Continuous Scale; 10-items) | Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance and 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. | 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. |
| Prosthesis Evaluation Questionnaire: Utility Score. | 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. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Non Amputee Control Group non-amputee healty controls | 5 |
| Total | 25 |
Baseline characteristics
| Characteristic | Entire Study Population | Non Amputee Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 3 Participants | 21 Participants |
| Age, Continuous | 46.5 years STANDARD_DEVIATION 14.2 | 57.2 years STANDARD_DEVIATION 15.7 | 51.9 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 16 Participants | 3 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
75 Meter Self Selected Walking Test
Time to Complete a 75 meter walking distance.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Knee 1 | 75 Meter Self Selected Walking Test | 65.1 seconds | Standard Deviation 10.2 |
| Prosthetic Knee 2 | 75 Meter Self Selected Walking Test | 64.0 seconds | Standard Deviation 10.3 |
| Non Amputee Control Group | 75 Meter Self Selected Walking Test | 54.0 seconds | Standard Deviation 6.9 |
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.
Time frame: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Knee 1 | Physical Functional Performance (Continuous Scale; 10-items) | 55.2 scores on a scale | Standard Deviation 14.8 |
| Prosthetic Knee 2 | Physical Functional Performance (Continuous Scale; 10-items) | 59.6 scores on a scale | Standard Deviation 16 |
| Non Amputee Control Group | Physical Functional Performance (Continuous Scale; 10-items) | 73.04 scores on a scale | Standard Deviation 15.67 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Knee 1 | Balance and Stability | 60.7 scores on a scale | Standard Deviation 24.3 |
| Prosthetic Knee 2 | Balance and Stability | 59.2 scores on a scale | Standard Deviation 25.4 |
| Non Amputee Control Group | Balance and Stability | 73.1 scores on a scale | Standard Deviation 21.3 |
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).
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prosthetic Knee 1 | Prosthesis Evaluation Questionnaire: Utility Score. | 6.0 score on a scale |
| Prosthetic Knee 2 | Prosthesis Evaluation Questionnaire: Utility Score. | 5.5 score on a scale |