Trial Outcomes & Findings for Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees (NCT NCT02240186)
NCT ID: NCT02240186
Last Updated: 2018-12-12
Results Overview
Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
Results posted on
2018-12-12
Participant Flow
Participant milestones
| Measure |
Prosthetic Knee Joints
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
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|---|---|
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Overall Study
STARTED
|
50
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Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
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27
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prosthetic Knee Joints
n=50 Participants
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
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|---|---|
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Age, Continuous
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69 years
STANDARD_DEVIATION 9 • n=50 Participants
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|
Sex: Female, Male
Female
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22 Participants
n=50 Participants
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Sex: Female, Male
Male
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28 Participants
n=50 Participants
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|
Region of Enrollment
United States
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50 participants
n=50 Participants
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PRIMARY outcome
Timeframe: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)Population: Activity measurement data were available for analysis on 46 baseline participants, 31 MPK participants, and 18 NMPK participants.
Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.
Outcome measures
| Measure |
Prosthetic Knee Joints
n=46 Participants
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
Prosthetic Knee Joint - MPK
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
Prosthetic Knee Joint - NMPK
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
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|---|---|---|---|
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Daily Activity Measured With Triaxial Accelerometers
Baseline
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15.64 % of Day
Standard Deviation 8362
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—
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—
|
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Daily Activity Measured With Triaxial Accelerometers
MPK
|
19.68 % of Day
Standard Deviation 11.88
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—
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—
|
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Daily Activity Measured With Triaxial Accelerometers
NMPK
|
18.23 % of Day
Standard Deviation 10.54
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—
|
—
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PRIMARY outcome
Timeframe: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)Population: Data for falls were available for analysis on 46 baseline participants, 30 MPK participants, and 17 NMPK participants.
The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.
Outcome measures
| Measure |
Prosthetic Knee Joints
n=46 Participants
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
Prosthetic Knee Joint - MPK
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
Prosthetic Knee Joint - NMPK
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
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|---|---|---|---|
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Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
Baseline
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2.0 Falls per month
Interval 0.0 to 6.0
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—
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—
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Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
MPK
|
0.0 Falls per month
Interval 0.0 to 3.25
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—
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—
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Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
NMPK
|
3.0 Falls per month
Interval 0.0 to 3.0
|
—
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—
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SECONDARY outcome
Timeframe: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)Population: Not all participants completed all the scales in the questionnaire.
The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements. The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life.
Outcome measures
| Measure |
Prosthetic Knee Joints
n=48 Participants
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
Prosthetic Knee Joint - MPK
n=33 Participants
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
Prosthetic Knee Joint - NMPK
n=23 Participants
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.
Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
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|---|---|---|---|
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Social Burden
|
62.21 Score on a scale
Standard Deviation 22.75
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71.71 Score on a scale
Standard Deviation 23.00
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66.06 Score on a scale
Standard Deviation 29.15
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Sounds
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76.96 Score on a scale
Standard Deviation 25.28
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81.70 Score on a scale
Standard Deviation 23.22
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85.13 Score on a scale
Standard Deviation 16.91
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Ambulation
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39.07 Score on a scale
Standard Deviation 17.14
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49.58 Score on a scale
Standard Deviation 24.61
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45.31 Score on a scale
Standard Deviation 20.94
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Appearance
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64.55 Score on a scale
Standard Deviation 18.81
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74.43 Score on a scale
Standard Deviation 20.64
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62.80 Score on a scale
Standard Deviation 19.37
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Frustration
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51.48 Score on a scale
Standard Deviation 29.44
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66.28 Score on a scale
Standard Deviation 28.67
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56.29 Score on a scale
Standard Deviation 28.83
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Perceived Response
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85.23 Score on a scale
Standard Deviation 12.29
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89.28 Score on a scale
Standard Deviation 12.88
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90.00 Score on a scale
Standard Deviation 9.91
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Residual Limb Health
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74.46 Score on a scale
Standard Deviation 19.95
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77.08 Score on a scale
Standard Deviation 15.58
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76.31 Score on a scale
Standard Deviation 18.56
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Utility
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53.96 Score on a scale
Standard Deviation 16.48
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64.09 Score on a scale
Standard Deviation 21.07
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52.52 Score on a scale
Standard Deviation 14.18
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Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Well Being
|
53.47 Score on a scale
Standard Deviation 21.81
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62.00 Score on a scale
Standard Deviation 22.18
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61.10 Score on a scale
Standard Deviation 20.28
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Adverse Events
Prosthetic Knee Joints
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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