Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

NCT ID: NCT05190354

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2022-06-24

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Xtremity Prosthesis

Xtremity Prosthesis fitting

Group Type: EXPERIMENTAL

Xtremity Polymer Prosthetic Socket

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Creations, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Berke, MS, CP, FAAOP

Role: PRINCIPAL_INVESTIGATOR

Medical Creations

Locations

Snell Prosthetics and Orthotic Laboratory

Little Rock, Arkansas, United States

Barber Prosthetics

Vancouver, , Canada

Countries

United States; Canada

Other Identifiers

CP-0001

Identifier Type: -

Identifier Source: org_study_id