Evaluation of Upper Extremity Prosthesis

May 3, 2017 updated by: University of Oklahoma

Evaluation of an Inexpensive Upper Extremity Prosthesis

The purpose of this study is to evaluate a design of prosthesis that is inexpensive and able to fit a multitude of individuals. This may offer an off the shelf item for those that cannot afford a customized prosthesis, or wish to have an inexpensive spare.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective study will be done on an inexpensive below elbow upper extremity prosthesis. Prestige Healthcare Technologies Ltd. has developed a prosthesis that is easily and inexpensively fabricated. The prosthesis is similar to a fitting frame used by some prosthetists in trial fits to ensure proper length and angulation of the terminal device. The prosthesis consists of two pieces of aluminum bar stock running midline the length of the residual limb. One bar is located anteriorly, the other posteriorly. A terminal device will be placed in the receiver on the distal end of the prosthesis. An aluminum band will connect the anterior and posterior bar stock for structural stability. A finished figure of eight harness will be utilized for control and suspension of the prosthesis. The research performed will be noninvasive. The check out will be based on the New York University (NYU) trans-radial prosthesis checkout form. Prestige Healthcare Technologies has donated an adult size trans-radial prosthesis to be utilized for this study.

Each patient will serve as their own control group. The control group will be considered using the same guidelines for testing function of the patient's current prosthesis, which we will refer to as alpha P. The patient will then be fitted with the inexpensive model, which we will refer to as beta P. The results will be compared to the NYU standard as well as comparing between the results of alpha P and beta P. Beta P will be the same prosthesis personalized for subjects with the harness adjusted to properly fit each individual.

The benefit of this study may provide an inexpensive versatile alternative to the current below elbow prosthesis. This version may be utilized as a spare prosthesis while the patient is unable to use his primary prosthesis.

Study Type

Interventional

Enrollment (Actual)

1

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
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic

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

14 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with unilateral transradial amputation
  • Neurologically intact
  • At least 6 months post amputation surgery
  • Skin integrity intact without ulceration

Exclusion Criteria:

  • Bilateral upper extremity amputees
  • Patients that are insensate
  • Patients with poor skin integrity
  • Patients whose residual limb lengths preclude them from using the transradial prosthesis that is being evaluated

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beta P Experimental
Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.
Device: Beta P Experimental
Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.
Other Names:
  • Inexpensive Prosthesis
Other: Alpha P Control
Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
Device: Alpha P Control
Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
Other Names:
  • Standard/Current Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correct application and maintenance of position of device
Time Frame: 1 day -- time it takes to take measurements and make observations
1 day -- time it takes to take measurements and make observations

Collaborators and Investigators

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

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Daniel Hunt, B.S., C.O., University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics

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

January 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORTHDH 07
  • 13099 (University of Oklahoma Health Sciences Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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