Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP) (POP)

March 21, 2016 updated by: Encore Medical, L.P.

A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis

The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • 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

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • George E. Wahlen Department of Veterans Affairs Medical Center
        • Contact:
        • Principal Investigator:
          • Erik Kubiak, MD

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • US Military veteran with transfemoral amputation that is not a result of dysvascular disease
  • Has used or is using a "socket suspension technology" prosthesis
  • Use of non-propulsive, passive microprocessor-regulated devices
  • Agrees not to participate in high levels of physical activity while in the study
  • Subject meets anatomical and eligibility criteria for the investigational device

Exclusion Criteria:

  • Currently on active military duty
  • More than 1 limb amputated
  • Has insulin dependent or adult onset diabetes
  • Recent tobacco use

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TREATMENT
Device: Percutaneous Osseintegrated Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant
Time Frame: 1 year
1 year
Changes in Bone Mineral Density as collected using DEXA scan
Time Frame: 1 year
1 year
Changes in implant exit site using Modified Holgers Skin Metric
Time Frame: 1 yr
1 yr
Analyze measurable changes in the stoma punch
Time Frame: 1 year
1 year
Analyze changes of walking and standing
Time Frame: 1 year
Three dimensional motion capture of walking and standing through a calibration volume that contains force plates
1 year
Analyze changes in metabolic efficiency
Time Frame: 1 year
Measure CO2 and O2 exhaled, total energy cost for walking at slow, normal, fast; self-selected and/or fixed speeds while wearing a two-way valve.
1 year
Analyze changes in 6 minute walk test
Time Frame: 1 year
1 year
Assess changes in Donning and Doffing prosthetic time
Time Frame: 1 year
1 year
Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test
Time Frame: 1 year
1 year
Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions
Time Frame: 1 yr
1 yr
Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)
Time Frame: 1 yr
1 yr
Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions
Time Frame: 1 yr
1 yr
Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function
Time Frame: 1 yr
1 yr
Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting
Time Frame: 1 yr
1 yr
Changes in at-home prosthetic usage using StepWatch activity monitor
Time Frame: 1 yr
1 yr

Collaborators and Investigators

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

Sponsor

Encore Medical, L.P.

Collaborators

VA Salt Lake City Health Care System

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

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • POP

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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