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| Sponsored by: |
University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00584103 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Transradial Amputation |
Device: Beta P prosthesis |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Placebo Control, Single Group Assignment |
| Official Title: | Evaluation of an Inexpensive Upper Extremity Prosthesis |
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2007 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Single arm comparing patients' own custom prosthesis with a prefabricated one.
|
Device: Beta P prosthesis
A prefabricated below elbow prosthesis will be compared to each patient's custom fitted prosthesis. Subjects will serve as their own controls.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Daniel Hunt, B.S., C.O. | University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics |
More Information
| Responsible Party: | University of Oklahoma Health Sciences Center ( Daniel Hunt, C.O. ) |
| Study ID Numbers: | ORTHDH 07, 13099 |
| Study First Received: | December 20, 2007 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00584103 |
| Health Authority: | United States: Institutional Review Board |
|
transradial amputation prosthesis prefabricated prosthesis |
inexpensive custom prosthesis adult individuals who have undergone a transradial amputation |
