Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

NCT05190354 | Completed FDA Device

• 1 other identifier: CP-0001
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Amputation; Prosthesis User

Keywords

transtibial; amputation; prosthesis; below knee

Outcome Measures

Primary Outcomes (4)

• 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 (10)

• Benefits to prosthetist - Casting Time

  21 days

• Benefits to prosthetist - Material Consumption

  21 days

• Benefits to prosthetist - Material Waste

  21 days

• Benefits to prosthetist - Resources

  21 days

• Benefits to prosthetist - Skill

  21 days

Study Arms (1)

Xtremity Prosthesis

EXPERIMENTAL

Xtremity Prosthesis fitting

Device: Xtremity Polymer Prosthetic Socket

Interventions

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

Xtremity Prosthesis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical Creations, Inc.: lead

Study Sites (2)

Snell Prosthetics and Orthotic Laboratory

Little Rock, Arkansas, 72205, United States

Location

Barber Prosthetics

Vancouver, VSX 2T4, Canada

Location

Study Officials

• Gary Berke, MS, CP, FAAOP

  Medical Creations

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 13, 2022
• Study Start: November 16, 2021
• Primary Completion: May 11, 2022
• Study Completion: June 24, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

US (1); CA (1)