Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

August 22, 2022 updated by: Medical Creations, Inc.
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
User Preference of the Xtremity Socket - Achievement of durability
Time Frame: 21 days
Device success defined as rate of achieving durability
21 days
User Preference of the Xtremity Socket - Socket Comfort Score
Time Frame: 21 Days
Rate of device success measured by Socket Comfort Score
21 Days
User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire
Time Frame: 21 Days
Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire
21 Days
User Preference of the Xtremity Socket - Activity
Time Frame: 21 Days
Rate of device success measured by activity level ranked low activity to high activity (1-10)
21 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Benefits to prosthetist - Casting Time
Time Frame: 21 days
Measured by time from casting to delivery in days
21 days
Benefits to prosthetist - Material Consumption
Time Frame: 21 days
Measured by amount of material consumed
21 days
Benefits to prosthetist - Material Waste
Time Frame: 21 days
Measured by amount of material wasted
21 days
Benefits to prosthetist - Resources
Time Frame: 21 days
Number of resources required to use
21 days
Benefits to prosthetist - Skill
Time Frame: 21 days
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
Time Frame: 21 days
Ease of adjustability ranked from difficult to easy (1-5)
21 days
Benefits to Patient - Mobility
Time Frame: 21 days
Measured by Amputee Mobility Predictor Assessment Tool
21 days
Benefits to Patient - Cosmesis
Time Frame: 21 days
Measured by Cosmesis survey question ranked from very unattractive to very attractive (1-5)
21 days
Benefits to patient - Number of Visits
Time Frame: 21 days
Measured as number of visits to achieve adequate fit in days
21 days
Device Safety - Composite of Device Related Adverse Events
Time Frame: 21 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical Creations, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gary Berke, MS, CP, FAAOP, Medical Creations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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