Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00584103
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Upper Extremity Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correct application and maintenance of position of device', 'timeFrame': '1 day -- time it takes to take measurements and make observations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transradial amputation', 'prosthesis', 'prefabricated prosthesis', 'inexpensive', 'custom prosthesis', 'adult transradial amputation'], 'conditions': ['Transradial Amputation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nEach 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with unilateral transradial amputation\n* Neurologically intact\n* At least 6 months post amputation surgery\n* Skin integrity intact without ulceration\n\nExclusion Criteria:\n\n* Bilateral upper extremity amputees\n* Patients that are insensate\n* Patients with poor skin integrity\n* Patients whose residual limb lengths preclude them from using the transradial prosthesis that is being evaluated'}, 'identificationModule': {'nctId': 'NCT00584103', 'briefTitle': 'Evaluation of Upper Extremity Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Evaluation of an Inexpensive Upper Extremity Prosthesis', 'orgStudyIdInfo': {'id': 'ORTHDH 07'}, 'secondaryIdInfos': [{'id': '13099', 'type': 'OTHER', 'domain': 'University of Oklahoma Health Sciences Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta P Experimental', 'description': '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.', 'interventionNames': ['Device: Beta P Experimental']}, {'type': 'OTHER', 'label': 'Alpha P Control', 'description': 'Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.', 'interventionNames': ['Device: Alpha P Control']}], 'interventions': [{'name': 'Alpha P Control', 'type': 'DEVICE', 'otherNames': ['Standard/Current Prosthesis'], 'description': 'Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.', 'armGroupLabels': ['Alpha P Control']}, {'name': 'Beta P Experimental', 'type': 'DEVICE', 'otherNames': ['Inexpensive Prosthesis'], 'description': '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.', 'armGroupLabels': ['Beta P Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Daniel Hunt, B.S., C.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}