Trial Outcomes & Findings for A Comparative Assessment of Transfemoral Prosthetic Sockets (NCT NCT04038580)
NCT ID: NCT04038580
Last Updated: 2025-09-29
Results Overview
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
After at least 3 weeks of prosthetic socket use
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Laminated, Then CJ, Then Infinite, Then Quatro
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then CJ, Then Quatro, Then Infinite
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Infinite, Then CJ, Then Quatro
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Infinite, Then Quatro, Then CJ
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Quatro, Then Infinite, Then CJ
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Quatro, Then CJ, Then Infinite
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
|---|---|---|---|---|---|---|
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Baseline Testing
STARTED
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5
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5
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5
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5
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4
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5
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Baseline Testing
COMPLETED
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5
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5
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5
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5
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4
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5
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Baseline Testing
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Washout 1
STARTED
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5
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5
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5
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5
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4
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5
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Washout 1
COMPLETED
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5
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5
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5
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4
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3
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5
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Washout 1
NOT COMPLETED
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0
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0
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0
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1
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1
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0
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Experimental Socket #1
STARTED
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5
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5
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5
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4
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3
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5
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Experimental Socket #1
COMPLETED
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5
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5
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5
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4
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3
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5
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Experimental Socket #1
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Wash-out 2
STARTED
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5
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5
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5
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4
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3
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5
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Wash-out 2
COMPLETED
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4
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5
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5
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2
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3
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4
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Wash-out 2
NOT COMPLETED
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1
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0
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0
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2
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0
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1
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Experimental Socket #2
STARTED
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4
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5
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5
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2
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3
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4
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Experimental Socket #2
COMPLETED
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4
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4
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5
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2
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3
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4
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Experimental Socket #2
NOT COMPLETED
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0
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1
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0
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0
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0
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0
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Wash-out 3
STARTED
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4
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4
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5
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2
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3
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4
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Wash-out 3
COMPLETED
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3
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4
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3
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2
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3
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4
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Wash-out 3
NOT COMPLETED
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1
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0
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2
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0
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0
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0
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Experimental Socket #3
STARTED
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3
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4
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3
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2
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3
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4
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Experimental Socket #3
COMPLETED
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3
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4
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3
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2
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3
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4
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Experimental Socket #3
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Laminated, Then CJ, Then Infinite, Then Quatro
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then CJ, Then Quatro, Then Infinite
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Infinite, Then CJ, Then Quatro
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Infinite, Then Quatro, Then CJ
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Quatro, Then Infinite, Then CJ
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
Laminated, Then Quatro, Then CJ, Then Infinite
Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition.
|
|---|---|---|---|---|---|---|
|
Washout 1
Death
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0
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0
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0
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1
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0
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0
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Washout 1
Withdrawal by Subject
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0
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0
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0
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0
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1
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0
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Wash-out 2
Withdrawal by Subject
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1
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0
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0
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2
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0
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1
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Experimental Socket #2
Withdrawal by Subject
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0
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1
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0
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0
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0
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0
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Wash-out 3
Withdrawal by Subject
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1
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0
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2
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0
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0
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0
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Baseline Characteristics
A Comparative Assessment of Transfemoral Prosthetic Sockets
Baseline characteristics by cohort
| Measure |
All Study Participants
n=29 Participants
This group represents all study participants
|
|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After at least 3 weeks of prosthetic socket usePopulation: All participants who successfully wore the socket at home for three weeks are included. We also exclude baseline data from individuals who did not successfully complete at least one experimental socket.
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Outcome measures
| Measure |
Laminated Socket
n=22 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=17 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=19 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Socket Fit Comfort Score
|
7.0 units on a scale
Standard Error 0.5
|
7.4 units on a scale
Standard Error 0.6
|
7.9 units on a scale
Standard Error 0.4
|
7.3 units on a scale
Standard Error 0.5
|
PRIMARY outcome
Timeframe: After at least 3 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental condition
The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health.
Outcome measures
| Measure |
Laminated Socket
n=22 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=17 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=19 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Frustration Subscale
|
54.6 units on a scale
Interval 41.5 to 67.8
|
65.3 units on a scale
Interval 49.6 to 80.9
|
61.7 units on a scale
Interval 46.6 to 76.8
|
51.9 units on a scale
Interval 38.0 to 65.9
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Perceived Response Subscale
|
85.1 units on a scale
Interval 79.5 to 90.8
|
90.0 units on a scale
Interval 83.3 to 96.7
|
89.9 units on a scale
Interval 83.4 to 96.4
|
87.3 units on a scale
Interval 81.3 to 93.3
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Social Burden Subscale
|
70.0 units on a scale
Interval 63.5 to 76.4
|
82.1 units on a scale
Interval 74.4 to 89.8
|
79.8 units on a scale
Interval 72.3 to 87.2
|
77.9 units on a scale
Interval 71.1 to 84.8
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Ambulation Subscale
|
52.4 units on a scale
Interval 45.2 to 59.5
|
66.6 units on a scale
Interval 58.1 to 75.0
|
66.9 units on a scale
Interval 58.7 to 75.0
|
57.1 units on a scale
Interval 49.6 to 64.6
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Prosthesis Utility Subscale
|
59.3 units on a scale
Interval 52.0 to 66.5
|
72.6 units on a scale
Interval 64.0 to 81.2
|
72.2 units on a scale
Interval 63.9 to 83.8
|
62.9 units on a scale
Interval 55.2 to 70.5
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Residual Limb Health Subscale
|
68.4 units on a scale
Interval 62.1 to 74.7
|
71.1 units on a scale
Interval 63.6 to 78.6
|
76.5 units on a scale
Interval 69.3 to 83.8
|
75.9 units on a scale
Interval 69.2 to 82.6
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Appearance Subscale
|
65.3 units on a scale
Interval 58.3 to 72.3
|
76.7 units on a scale
Interval 68.4 to 85.0
|
73.3 units on a scale
Interval 65.3 to 81.3
|
62.1 units on a scale
Interval 54.7 to 69.5
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Sounds Subscale
|
65.2 units on a scale
Interval 55.6 to 74.9
|
78.5 units on a scale
Interval 67.1 to 89.9
|
69.5 units on a scale
Interval 58.4 to 80.5
|
71.0 units on a scale
Interval 61.8 to 82.2
|
|
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
Well-Being Subscale
|
67.9 units on a scale
Interval 61.7 to 74.1
|
65.4 units on a scale
Interval 58.1 to 72.8
|
77.2 units on a scale
Interval 70.2 to 84.3
|
73.5 units on a scale
Interval 66.9 to 80.1
|
PRIMARY outcome
Timeframe: After at least 3 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental socket are included. One participants surveys for the laminated condition were lost in the mail.
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation.
Outcome measures
| Measure |
Laminated Socket
n=21 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=17 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=19 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Activities Specific Balance Confidence Scale
|
68.7 units on a scale
Standard Error 2.8
|
70.4 units on a scale
Standard Error 3.3
|
67.8 units on a scale
Standard Error 3.2
|
68.8 units on a scale
Standard Error 3.0
|
PRIMARY outcome
Timeframe: after at least 4 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition.
The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials.
Outcome measures
| Measure |
Laminated Socket
n=22 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=18 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=16 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Mobility as Measured by the 10-meter Walk Test
|
1.06 m/s
Standard Error .03
|
1.09 m/s
Standard Error .03
|
1.07 m/s
Standard Error .03
|
1.08 m/s
Standard Error .03
|
PRIMARY outcome
Timeframe: after at least 4 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental socket where included. For those 23 participants, only conditions where the participant wore the socket for four weeks are included
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. The best of three trials was recorded.
Outcome measures
| Measure |
Laminated Socket
n=22 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=15 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=18 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Mobility as Measured by Timed Up and Go (TUG)
|
15.0 seconds
Standard Error .39
|
14.4 seconds
Standard Error .48
|
14.4 seconds
Standard Error .50
|
15.1 seconds
Standard Error .45
|
PRIMARY outcome
Timeframe: after at least 4 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition.
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Outcome measures
| Measure |
Laminated Socket
n=22 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=16 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=18 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Mobility as Measured by Five Times Sit To Stand (FTSTS)
|
24.9 seconds
Standard Error 1.1
|
21.8 seconds
Standard Error 1.4
|
24.0 seconds
Standard Error 1.4
|
23.9 seconds
Standard Error 1.3
|
PRIMARY outcome
Timeframe: After at least 3 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for three weeks before dropping out of the study or failing the socket condition. Surveys for one participant in the laminated condition were lost in the mail.
The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average.
Outcome measures
| Measure |
Laminated Socket
n=21 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=17 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=19 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form
|
50.5 T Score
Standard Error 1.0
|
50.6 T Score
Standard Error 1.1
|
52.0 T Score
Standard Error 1.1
|
49.4 T Score
Standard Error 1.0
|
SECONDARY outcome
Timeframe: After at least 3 weeks of prosthetic socket usePopulation: All participants with data. The data from the sensor was not reliable, so data was used from self report.
Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week.
Outcome measures
| Measure |
Laminated Socket
n=23 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=14 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=15 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Prosthetic Wear Time
|
1.77 average number of times per day
Standard Deviation .837
|
1.49 average number of times per day
Standard Deviation 1.7
|
1.47 average number of times per day
Standard Deviation .53
|
1.05 average number of times per day
Standard Deviation .35
|
SECONDARY outcome
Timeframe: After 4 weeks of prosthetic socket usePopulation: All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition.
The L test is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side. The fastest time out of three trials was recorded.
Outcome measures
| Measure |
Laminated Socket
n=22 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=15 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=18 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Time to Complete the L Test
|
33.1 seconds
Standard Error .8
|
32.2 seconds
Standard Error 1.0
|
31.2 seconds
Standard Error 1.1
|
32.6 seconds
Standard Error 1.0
|
SECONDARY outcome
Timeframe: After three weeks of device usePopulation: All participants with at least one full day of accelerometer data.
Participants will wear accelerometers to measure their average step count per day over a one week time frame. Data will be collected after at least three weeks of socket use.
Outcome measures
| Measure |
Laminated Socket
n=28 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=16 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=15 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=16 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Steps Per Day Taken at Home
|
2526 steps/day
Standard Deviation 1857
|
2238 steps/day
Standard Deviation 1842
|
2224 steps/day
Standard Deviation 1626
|
2616 steps/day
Standard Deviation 1828
|
SECONDARY outcome
Timeframe: After at least three weeks of prosthetic socket use.Population: Data were compared to the participants prescribed socket, which was either laminated (n=26) or CJ (n=3). There is only data for individuals who successfully completed at least two conditions (i.e. baseline and experimental). Since this is a relative measure, there is less data than for other outcomes. For example, only individuals who were prescribed the CJ would have a value for the laminated condition. Several participants also did not complete this survey.
The prosthetic preference questionnaire consisted of a single question which asked which socket the participant preferred on a 100 mm visual analog scale from their prescribed socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the experimental socket.
Outcome measures
| Measure |
Laminated Socket
n=1 Participants
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=10 Participants
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=14 Participants
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=13 Participants
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Prosthetic Preference
|
4 units on a scale
Standard Error NA
There is only one data point so a standard error cannot be calculated
|
33.4 units on a scale
Standard Error 11.6
|
48.3 units on a scale
Standard Error 11.0
|
37.4 units on a scale
Standard Error 9.6
|
Adverse Events
Laminated Socket
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
CJ Socket
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Quatro
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Infinite Socket
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laminated Socket
n=28 participants at risk
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=25 participants at risk
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=20 participants at risk
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=24 participants at risk
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Infections and infestations
Death
|
3.6%
1/28 • Number of events 1 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/25 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/20 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/24 • over 4 weeks of prosthetic socket use, up to two months
|
|
Musculoskeletal and connective tissue disorders
Cancer
|
0.00%
0/28 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/25 • over 4 weeks of prosthetic socket use, up to two months
|
5.0%
1/20 • Number of events 1 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/24 • over 4 weeks of prosthetic socket use, up to two months
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.00%
0/28 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/25 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/20 • over 4 weeks of prosthetic socket use, up to two months
|
4.2%
1/24 • Number of events 1 • over 4 weeks of prosthetic socket use, up to two months
|
Other adverse events
| Measure |
Laminated Socket
n=28 participants at risk
During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition.
|
CJ Socket
n=25 participants at risk
Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation.
|
Quatro
n=20 participants at risk
Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado)
|
Infinite Socket
n=24 participants at risk
Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Wound
|
0.00%
0/28 • over 4 weeks of prosthetic socket use, up to two months
|
16.0%
4/25 • Number of events 4 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/20 • over 4 weeks of prosthetic socket use, up to two months
|
12.5%
3/24 • Number of events 3 • over 4 weeks of prosthetic socket use, up to two months
|
|
Musculoskeletal and connective tissue disorders
Injurious fall requiring medical attention
|
7.1%
2/28 • Number of events 2 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/25 • over 4 weeks of prosthetic socket use, up to two months
|
5.0%
1/20 • Number of events 1 • over 4 weeks of prosthetic socket use, up to two months
|
4.2%
1/24 • Number of events 1 • over 4 weeks of prosthetic socket use, up to two months
|
|
Musculoskeletal and connective tissue disorders
Instability/Discomfort
|
0.00%
0/28 • over 4 weeks of prosthetic socket use, up to two months
|
36.0%
9/25 • Number of events 9 • over 4 weeks of prosthetic socket use, up to two months
|
10.0%
2/20 • Number of events 2 • over 4 weeks of prosthetic socket use, up to two months
|
20.8%
5/24 • Number of events 5 • over 4 weeks of prosthetic socket use, up to two months
|
|
Product Issues
Device Issues
|
0.00%
0/28 • over 4 weeks of prosthetic socket use, up to two months
|
0.00%
0/25 • over 4 weeks of prosthetic socket use, up to two months
|
20.0%
4/20 • Number of events 4 • over 4 weeks of prosthetic socket use, up to two months
|
4.2%
1/24 • Number of events 1 • over 4 weeks of prosthetic socket use, up to two months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place