Trial Outcomes & Findings for Southern Bone & Joint Study - Brimless Sockets (NCT NCT01416129)
NCT ID: NCT01416129
Last Updated: 2014-06-02
Results Overview
Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 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.
Results posted on
2014-06-02
Participant Flow
Participant milestones
| Measure |
Standard of Care Prosthetic Socket (Ischial Containment)
In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition.
|
Prosthetic Socket (Experimental): Brimless Socket
5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
|
|---|---|---|
|
Control Condition: Ischial Containment
STARTED
|
5
|
5
|
|
Control Condition: Ischial Containment
COMPLETED
|
5
|
5
|
|
Control Condition: Ischial Containment
NOT COMPLETED
|
0
|
0
|
|
Experimental Condition: Brimless
STARTED
|
5
|
5
|
|
Experimental Condition: Brimless
COMPLETED
|
5
|
5
|
|
Experimental Condition: Brimless
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Southern Bone & Joint Study - Brimless Sockets
Baseline characteristics by cohort
| Measure |
Active Comparator: Prosthetic Socket Standard of Care
n=5 Participants
This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity.
|
Active Comparator: Prosthetic Brimless Socket
n=5 Participants
This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 14.7 • n=93 Participants
|
42.9 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
42.9 years
STANDARD_DEVIATION 14.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 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.Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
Outcome measures
Outcome data not reported
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.Balance and stability will be assessed for limits of stability and postural stability.
Outcome measures
Outcome data not reported
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.Validated surveys will be used to solicit participants' subjective experience and feedback.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 10 minutes after fitting with both socketsPressure sensors are placed on the skin and measured.
Outcome measures
| Measure |
Control Condition: Prosthetic Socket Standard of Care
n=10 Participants
|
Active Comparator/Experimental: Prosthetic Brimless Socket
n=10 Participants
|
|---|---|---|
|
Socket Pressure
|
841 mm Hg
Standard Deviation 600
|
819 mm Hg
Standard Deviation 455
|
Adverse Events
Vacuum Assisted Socket
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Socket
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