Evaluation of Upper Extremity Prosthesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584103
First received: December 20, 2007
Last updated: December 10, 2013
Last verified: December 2013
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an Inexpensive Upper Extremity Prosthesis

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • correct application and maintenance of position of device [ Time Frame: 1 day -- time it takes to take measurements and make observations ] [ Designated as safety issue: No ]

Enrollment: 1
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.

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 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584103

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00584103     History of Changes
Other Study ID Numbers: ORTHDH 07, 13099
Study First Received: December 20, 2007
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
transradial amputation
prosthesis
prefabricated prosthesis
inexpensive
custom prosthesis
adult individuals who have undergone a transradial amputation

ClinicalTrials.gov processed this record on July 28, 2014