Socket Designs of Transfemoral Amputees.
Conditions
Brief summary
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.
Interventions
DEVICEStandard of care socket
Amputees' preferred socket.
DEVICEProsthetic brimless socket
Study socket
Sponsors
Southern Bone & Joint Specialists, P.A.
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Unilateral transfemoral or knee-disarticulation amputee * 18 to 85 years of age * K3 (variable cadence and community) ambulators; * Be able to independently provide informed consent * Be willing to comply with study procedures.
Exclusion criteria
* History of chronic skin breakdown on the residual limb * Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking) * Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate * Unwillingness/inability to follow instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait | 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. |
| Balance and Stability | 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. |
| Quality of Life | 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. |
| Socket Pressure | 10 minutes after fitting with both sockets | Pressure sensors are placed on the skin and measured. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator: Prosthetic Socket Standard of Care This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity. | 5 |
| Active Comparator: Prosthetic Brimless Socket This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Active Comparator: Prosthetic Brimless Socket | Active Comparator: Prosthetic Socket Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Continuous | 42.9 years STANDARD_DEVIATION 14.7 | 42.9 years STANDARD_DEVIATION 14.7 | 42.9 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Balance and Stability
Balance and stability will be assessed for limits of stability and postural stability.
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.
Primary
Gait
Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
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.
Primary
Quality of Life
Validated surveys will be used to solicit participants' subjective experience and feedback.
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.
Primary
Socket Pressure
Pressure sensors are placed on the skin and measured.
Time frame: 10 minutes after fitting with both sockets
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Condition: Prosthetic Socket Standard of Care | Socket Pressure | 841 mm Hg | Standard Deviation 600 |
| Active Comparator/Experimental: Prosthetic Brimless Socket | Socket Pressure | 819 mm Hg | Standard Deviation 455 |