Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

Study Overview
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Brief Summary
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The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.

Official Title
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Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

Conditions
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Amputation

Intervention / Treatment
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* Device: Ischial Ramus Containment (IRC)
* Device: Dynamic Socket Ischial Ramus Containment (IRC)
* Device: Sub-Ischial Interface (Sub-I)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral above the knee amputees of non-dysvascular etiology 100-275 lbs ≥ 1 yr. of prosthetic experience Independent community ambulator Self-reported ability to walk for 20min consecutively Exclusion Criteria: Above the knee amputees of dysvascular etiologies Body weight <100 or >275 lbs Does not speak English or Spanish Use of an assistive device (i.e. canes, walkers) Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees Known skin issues Known cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Socket 1 (Ischial Ramus Containment)<br>This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket. | Device: Ischial Ramus Containment (IRC)<br>* Ischial Ramus Containment (IRC) is the standard of care socket<br>|
| Active Comparator: Socket 2 (Dynamic Socket IRC)<br>This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket. | Device: Dynamic Socket Ischial Ramus Containment (IRC)<br>* Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket<br>|
| Active Comparator: Socket 3 (Sub-Ischial Interface)<br>This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket. | Device: Sub-Ischial Interface (Sub-I)<br>* Sub-Ischial Interface (Sub-I) is a comparator study socket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Temperature | Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed | Accommodation with new prosthetic sockets is approximately 10 days | 
| Perspiration | Perspiration will be measured by tare weight (grams) following treadmill walking. | Accommodation with new prosthetic sockets is approximately 10 days | 
| Vertical Interface Movement (Pistoning) | Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray. | Accommodation with new prosthetic sockets is approximately 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance and Stability | The gold standard test of standing balance is the sensory organization test (SOT) administered on the Neurocom Equitest platform. The SOT score is a unitless number. Subjects stand on a pair of platforms that record force data and tilt in the sagittal plane during 6 varying conditions that challenge the visual, vestibular and somatosensory systems. With compromised ability to use an ankle strategy for balance, a hip strategy is routinely adopted, therefore higher interface trim lines could adversely affect performance on this test. | Accommodation with new prosthetic sockets is approximately 10 days | 
| Comfort | The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets. | Accommodation with new prosthetic sockets is approximately 10 days | 
| Preference | Patients will be asked which socket they preferred. | Accommodation with new prosthetic sockets is approximately 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfemoral, amputation, perspiration, socket, socket comfort