Trial Outcomes & Findings for Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis (NCT NCT01473992)
NCT ID: NCT01473992
Last Updated: 2023-12-12
Results Overview
Time to Complete a 75 meter walking distance.
COMPLETED
NA
25 participants
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.
2023-12-12
Participant Flow
Participant milestones
| Measure |
Prosthetic Knee 1 Then Prosthetic Knee 2
Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium).
|
Prosthetic Knee 2 Then Prosthetic Knee 1
Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg).
|
Control (Non-amputees)
Non-amputee control group
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
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.
|
Non Amputee Control Group
n=5 Participants
non-amputee healty controls
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Prosthetic Knee 1
n=20 Participants
Otto Bock C-Leg: Amputees' preferred prosthetic knee.
|
Prosthetic Knee 2
n=20 Participants
Otto Bock Genium: Study knee.
|
Non Amputee Control Group
n=5 Participants
healthy, non-amputee controls
|
|---|---|---|---|
|
75 Meter Self Selected Walking Test
|
65.1 seconds
Standard Deviation 10.2
|
64.0 seconds
Standard Deviation 10.3
|
54.0 seconds
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Prosthetic Knee 1
n=20 Participants
Otto Bock C-Leg: Amputees' preferred prosthetic knee.
|
Prosthetic Knee 2
n=20 Participants
Otto Bock Genium: Study knee.
|
Non Amputee Control Group
n=5 Participants
healthy, non-amputee controls
|
|---|---|---|---|
|
Physical Functional Performance (Continuous Scale; 10-items)
|
55.2 scores on a scale
Standard Deviation 14.8
|
59.6 scores on a scale
Standard Deviation 16.0
|
73.04 scores on a scale
Standard Deviation 15.67
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Prosthetic Knee 1
n=10 Participants
Otto Bock C-Leg: Amputees' preferred prosthetic knee.
|
Prosthetic Knee 2
n=10 Participants
Otto Bock Genium: Study knee.
|
Non Amputee Control Group
n=5 Participants
healthy, non-amputee controls
|
|---|---|---|---|
|
Balance and Stability
|
60.7 scores on a scale
Standard Deviation 24.3
|
59.2 scores on a scale
Standard Deviation 25.4
|
73.1 scores on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Prosthetic Knee 1
n=20 Participants
Otto Bock C-Leg: Amputees' preferred prosthetic knee.
|
Prosthetic Knee 2
n=20 Participants
Otto Bock Genium: Study knee.
|
Non Amputee Control Group
healthy, non-amputee controls
|
|---|---|---|---|
|
Prosthesis Evaluation Questionnaire: Utility Score.
|
6.0 score on a scale
Interval 2.0 to 7.0
|
5.5 score on a scale
Interval 2.0 to 7.0
|
—
|
Adverse Events
Prosthetic Knee 1
Prosthetic Knee 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place