Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2007-01-31
2007-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Neurologically intact
* At least 6 months post amputation surgery
* Skin integrity intact without ulceration
Exclusion Criteria
* 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
18 Years
89 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Daniel Hunt, B.S., C.O.
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics
Locations
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University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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13099
Identifier Type: OTHER
Identifier Source: secondary_id
ORTHDH 07
Identifier Type: -
Identifier Source: org_study_id
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