Evaluation of Upper Extremity Prosthesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of an Inexpensive Upper Extremity Prosthesis

Conditions
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Transradial Amputation

Intervention / Treatment
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* Device: Alpha P Control
* Device: Beta P Experimental


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta P Experimental<br>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<br>* 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.<br>* Other names: Inexpensive Prosthesis;|
| Other: Alpha P Control<br>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<br>* Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.<br>* Other names: Standard/Current Prosthesis;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inexpensive, transradial amputation, prosthesis, prefabricated prosthesis, custom prosthesis, adult transradial amputation