An interventional study of Otto Bock C-Leg and Otto Bock Genium in Other and Unspecified Complications of Amputation Stump, sponsored by Jason Highsmith. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Jason Highsmith · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Jason Highsmith as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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).
Device: Otto Bock C-Leg
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)
Device: Otto Bock Genium
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.
Amputees' preferred prosthetic knee.
Study knee.
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.
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.
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.
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.
| Milestone | Prosthetic Knee 1 Then Prosthetic Knee 2 | Prosthetic Knee 2 Then Prosthetic Knee 1 | Control (Non-amputees) |
|---|---|---|---|
| Started | 10 | 10 | 5 |
| Completed | 10 | 10 | 5 |
| Not completed | 0 | 0 | 0 |
Time to Complete a 75 meter walking distance.
| seconds | Prosthetic Knee 1 | Prosthetic Knee 2 | Non Amputee Control Group |
|---|---|---|---|
| 75 Meter Self Selected Walking Test | 65.1 ± 10.2 | 64.0 ± 10.3 | 54.0 ± 6.9 |
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.
| scores on a scale | Prosthetic Knee 1 | Prosthetic Knee 2 | Non Amputee Control Group |
|---|---|---|---|
| Balance and Stability | 60.7 ± 24.3 | 59.2 ± 25.4 | 73.1 ± 21.3 |
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).
| score on a scale | Prosthetic Knee 1 | Prosthetic Knee 2 |
|---|---|---|
| Prosthesis Evaluation Questionnaire: Utility Score. | 6.0 (2 to 7) | 5.5 (2 to 7) |
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.
| scores on a scale | Prosthetic Knee 1 | Prosthetic Knee 2 | Non Amputee Control Group |
|---|---|---|---|
| Physical Functional Performance (Continuous Scale; 10-items) | 55.2 ± 14.8 | 59.6 ± 16.0 | 73.04 ± 15.67 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prosthetic Knee 1 | — | 0/20 (0%) | 0/20 (0%) |
| Prosthetic Knee 2 | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Entire Study Population | Non Amputee Control Group | Total |
|---|---|---|---|
| Mean | 46.5 ± 14.2 | 57.2 ± 15.7 | 51.9 ± 15.0 |
| Age, Categorical(Participants) | Entire Study Population | Non Amputee Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 3 | 21 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Entire Study Population | Non Amputee Control Group | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 16 | 3 | 19 |
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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