Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT02773056
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2015-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2016-05-13', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Temperature', 'timeFrame': 'Accommodation with new prosthetic sockets is approximately 10 days', 'description': 'Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed'}, {'measure': 'Perspiration', 'timeFrame': 'Accommodation with new prosthetic sockets is approximately 10 days', 'description': 'Perspiration will be measured by tare weight (grams) following treadmill walking.'}, {'measure': 'Vertical Interface Movement (Pistoning)', 'timeFrame': 'Accommodation with new prosthetic sockets is approximately 10 days', 'description': 'Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray.'}], 'secondaryOutcomes': [{'measure': 'Balance and Stability', 'timeFrame': 'Accommodation with new prosthetic sockets is approximately 10 days', 'description': 'The gold standard test of standing balance is the sensory organization test (SOT) administered on the Neurocom Equitest platform. The SOT score is a unitless number. Subjects stand on a pair of platforms that record force data and tilt in the sagittal plane during 6 varying conditions that challenge the visual, vestibular and somatosensory systems. With compromised ability to use an ankle strategy for balance, a hip strategy is routinely adopted, therefore higher interface trim lines could adversely affect performance on this test.'}, {'measure': 'Comfort', 'timeFrame': 'Accommodation with new prosthetic sockets is approximately 10 days', 'description': "The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets."}, {'measure': 'Preference', 'timeFrame': 'Accommodation with new prosthetic sockets is approximately 10 days', 'description': 'Patients will be asked which socket they preferred.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transfemoral', 'amputation', 'perspiration', 'socket', 'socket comfort'], 'conditions': ['Amputation']}, 'referencesModule': {'references': [{'pmid': '33856157', 'type': 'DERIVED', 'citation': 'Kahle JT, Miro RM, Ho LT, Porter MR, Lura DJ, Carey SL, Lunseth P, Swanson AE, Highsmith MJ. Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial. Prosthet Orthot Int. 2021 Aug 1;45(4):304-312. doi: 10.1097/PXR.0000000000000013.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral above the knee amputees of non-dysvascular etiology\n* 100-275 lbs\n* ≥ 1 yr. of prosthetic experience\n* Independent community ambulator\n* Self-reported ability to walk for 20min consecutively\n\nExclusion Criteria:\n\n* Above the knee amputees of dysvascular etiologies\n* Body weight \\<100 or \\>275 lbs\n* Does not speak English or Spanish\n* Use of an assistive device (i.e. canes, walkers)\n* Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees\n* Known skin issues\n* Known cognitive impairment'}, 'identificationModule': {'nctId': 'NCT02773056', 'briefTitle': 'Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee', 'orgStudyIdInfo': {'id': 'Pro00021886'}, 'secondaryIdInfos': [{'id': 'CDMRP-MR140125', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Socket 1 (Ischial Ramus Containment)', 'description': 'This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket.', 'interventionNames': ['Device: Ischial Ramus Containment (IRC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Socket 2 (Dynamic Socket IRC)', 'description': 'This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket.', 'interventionNames': ['Device: Dynamic Socket Ischial Ramus Containment (IRC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Socket 3 (Sub-Ischial Interface)', 'description': 'This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket.', 'interventionNames': ['Device: Sub-Ischial Interface (Sub-I)']}], 'interventions': [{'name': 'Ischial Ramus Containment (IRC)', 'type': 'DEVICE', 'description': 'Ischial Ramus Containment (IRC) is the standard of care socket', 'armGroupLabels': ['Socket 1 (Ischial Ramus Containment)']}, {'name': 'Dynamic Socket Ischial Ramus Containment (IRC)', 'type': 'DEVICE', 'description': 'Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket', 'armGroupLabels': ['Socket 2 (Dynamic Socket IRC)']}, {'name': 'Sub-Ischial Interface (Sub-I)', 'type': 'DEVICE', 'description': 'Sub-Ischial Interface (Sub-I) is a comparator study socket', 'armGroupLabels': ['Socket 3 (Sub-Ischial Interface)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Jason Highsmith, PhD, CP, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}