Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

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

Study Overview

• Status: Completed
• Conditions: Amputation; Prosthesis User
• Intervention / Treatment: Device: Xtremity Polymer Prosthetic Socket

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada, VSX 2T4
    • Barber Prosthetics
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Snell Prosthetics and Orthotic Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xtremity Prosthesis; Xtremity Prosthesis fitting	Device: Xtremity Polymer Prosthetic Socket; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical Creations, Inc.
• Investigators: Principal Investigator: Gary Berke, MS, CP, FAAOP, Medical Creations

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: prosthesis; amputation; transtibial; below knee
• Other Study ID Numbers: CP-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No