Evaluation of Upper Extremity Prosthesis
Evaluation of an Inexpensive Upper Extremity Prosthesis
2 other identifiers
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedMay 8, 2017
May 1, 2017
6 months
December 20, 2007
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
correct application and maintenance of position of device
1 day -- time it takes to take measurements and make observations
Study Arms (2)
Beta P Experimental
EXPERIMENTALSubjects 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
OTHERSubjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
Interventions
Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.
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.
Eligibility Criteria
You may qualify if:
- Adult patients with unilateral transradial amputation
- Neurologically intact
- At least 6 months post amputation surgery
- Skin integrity intact without ulceration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
Oklahoma City, Oklahoma, 73104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Hunt, B.S., C.O.
University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 2, 2008
Study Start
January 1, 2007
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
May 8, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share