Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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
Snell Prosthetics and Orthotic Laboratory
Little Rock, Arkansas, United States
Barber Prosthetics
Vancouver, Canada
User Preference of the Xtremity Socket - Achievement of durability
Device success defined as rate of achieving durability
Time frame: 21 days
User Preference of the Xtremity Socket - Socket Comfort Score
Rate of device success measured by Socket Comfort Score
Time frame: 21 Days
User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire
Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire
Time frame: 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)
Time frame: 21 Days
Benefits to prosthetist - Casting Time
Measured by time from casting to delivery in days
Time frame: 21 days
Benefits to prosthetist - Material Consumption
Measured by amount of material consumed
Time frame: 21 days
Benefits to prosthetist - Material Waste
Measured by amount of material wasted
Time frame: 21 days
Benefits to prosthetist - Resources
Number of resources required to use
Time frame: 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Benefits to prosthetist - Skill
Level of skill set required to use ranked on a scale from very easy to very difficult (1-5)
Time frame: 21 days
Benefits to prosthetist - Adjustability
Ease of adjustability ranked from difficult to easy (1-5)
Time frame: 21 days
Benefits to Patient - Mobility
Measured by Amputee Mobility Predictor Assessment Tool
Time frame: 21 days
Benefits to Patient - Cosmesis
Measured by Cosmesis survey question ranked from very unattractive to very attractive (1-5)
Time frame: 21 days
Benefits to patient - Number of Visits
Measured as number of visits to achieve adequate fit in days
Time frame: 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.
Time frame: 21 days