Post Market Clinical Protocol - Xtremity Polymer Prosthet... | NCT05190354

NCT05190354

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Xtremity Prosthesis	Experimental	Xtremity Prosthesis fitting	Device: Xtremity Polymer Prosthetic Socket

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xtremity Polymer Prosthetic Socket	Device	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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Snell Prosthetics and Orthotic Laboratory		Little Rock	Arkansas	72205	United States
Barber Prosthetics