Southern Bone & Joint Study - Brimless Sockets

Study Overview
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Brief Summary
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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.

Official Title
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Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces

Conditions
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Socket Designs of Transfemoral Amputees.

Intervention / Treatment
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* Device: Standard of care socket
* Device: Prosthetic brimless socket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Prosthetic socket standard of care<br> | Device: Standard of care socket<br>* Amputees' preferred socket.<br>|
| Active Comparator: Active Comparator: Prosthetic brimless socket<br> | Device: Prosthetic brimless socket<br>* Study socket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait | Gait will be assessed in terms of biomechanics and spatiotemporal parameters. | 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 | Balance and stability will be assessed for limits of stability and postural 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. | 
| Quality of Life | Validated surveys will be used to solicit participants' subjective experience and feedback. | 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. | 
| Socket Pressure | Pressure sensors are placed on the skin and measured. | 10 minutes after fitting with both sockets |