Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Study Overview
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Brief Summary
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Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.

Official Title
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Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Conditions
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Amputation, Prosthesis User

Intervention / Treatment
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* Device: Xtremity Polymer Prosthetic Socket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥ 19 years old Unilateral or bilateral transtibial amputation Subject has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form. Currently using a standard carbon fiber or high temperature thermoplastic prosthetic socket. Residual limb is between 26-34 cm circumference with a liner (when measured 4cm proximal to distal end) Subject is eligible for standard carbon fiber or high temperature thermoplastic prosthetic socket if necessary. Must be able to ambulate at least 100 yards with or without an assistive device. Must be able to don and doff a prosthesis independently. Estimated life expectancy > 1 year Exclusion Criteria: Amputation < 6 months prior to enrollment Residual limb less than (<) 26cm and greater than (>) 34cm circumference at the distal end. Body weight greater than (>) 275lbs. Syme's amputations or total limb length over 30cm Some bulbous or irregular limb shapes Build height and circumference limitations Wounds or skin issues that preclude normal fit Unusual alignment of the socket or foot Alignment outside the capability of the Xtremity System. Planned for any major surgery within 6 months of enrollment. Subject is pregnant or breastfeeding Subject is incarcerated. Subject anticipates that the socket will frequently be subject to temperatures greater than 110 degrees F while in their possession. Subject anticipates that the socket will frequently be subject to direct sunlight Limb circumference at the mid-patella tendon exceeds the maximum circumference (see sizing chart in the instructions for use) Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study. Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre and post-treatment.

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects with transtibial unilateral or bilateral amputation who have experience using carbon fiber or high temperature thermoplastic prosthetic socket and are at least 6-months post-amputation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xtremity Prosthesis<br>Xtremity Prosthesis fitting | Device: Xtremity Polymer Prosthetic Socket<br>* Subjects with transtibial unilateral or bilateral amputation who have experience using a standard carbon fiber or high temperature thermoplastic prosthetic socket will be evaluated and fitted with a below knee prosthesis socket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Preference of the Xtremity Socket - Achievement of durability | Device success defined as rate of achieving durability | 21 days | 
| User Preference of the Xtremity Socket - Socket Comfort Score | Rate of device success measured by Socket Comfort Score | 21 Days | 
| User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire | Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire | 21 Days | 
| User Preference of the Xtremity Socket - Activity | Rate of device success measured by activity level ranked low activity to high activity (1-10) | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefits to prosthetist - Casting Time | Measured by time from casting to delivery in days | 21 days | 
| Benefits to prosthetist - Material Consumption | Measured by amount of material consumed | 21 days | 
| Benefits to prosthetist - Material Waste | Measured by amount of material wasted | 21 days | 
| Benefits to prosthetist - Resources | Number of resources required to use | 21 days | 
| Benefits to prosthetist - Skill | Level of skill set required to use ranked on a scale from very easy to very difficult (1-5) | 21 days | 
| Benefits to prosthetist - Adjustability | Ease of adjustability ranked from difficult to easy (1-5) | 21 days | 
| Benefits to Patient - Mobility | Measured by Amputee Mobility Predictor Assessment Tool | 21 days | 
| Benefits to Patient - Cosmesis | Measured by Cosmesis survey question ranked from very unattractive to very attractive (1-5) | 21 days | 
| Benefits to patient - Number of Visits | Measured as number of visits to achieve adequate fit in days | 21 days | 
| Device Safety - Composite of Device Related Adverse Events | Composite of device related Adverse Events (DAE) assessed throughout 21 days after prosthetic fitting. DAE is defined as a composite of all cause death, socket site skin problems that prevent wearing a prosthetic, socket site infection, and falls due to socket malfunction that result in injury. | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transtibial, amputation, prosthesis, below knee