NCT00584103

Evaluation of Upper Extremity Prosthesis

Evaluation of an Inexpensive Upper Extremity Prosthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Transradial Amputation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2008-01-02
• Last updated: 2017-05-08

Locations

1 site across 1 country: United States