Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02334618
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Activity Measure (PAM-13) Questionnaire', 'timeFrame': 'Follow Up Visits up to 1-Year', 'description': 'A subjective evaluation of perceived compliance with physician instructions'}], 'secondaryOutcomes': [{'measure': 'X-ray (AP and Lateral)', 'timeFrame': 'Follow Up Visits up to 1-Year', 'description': 'Subjectively evaluate fracture healing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankle Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who present to the University of Utah emergency department with ankle fractures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years of age or older\n* Patient has an ankle fracture\n* Patient speaks English\n* Patient weighs between 100 and 250 pounds\n* Patient lives in close enough proximity to the hospital to return for all appointments (\\~100 miles)\n\nExclusion Criteria:\n\n* Patient is younger than 18 years of age\n* Patient has multiple fractures that would alter weight bearing protocol\n* Patient does not speak English\n* Patient weighs less than 100 pounds or more than 250 pounds\n* Patient does not live in close enough proximity to the hospital to return for all appointments (\\~\\>100 miles)\n* Patient has a traumatic brain injury that would make it so they cannot consent\n* Patient has diabetes'}, 'identificationModule': {'nctId': 'NCT02334618', 'briefTitle': 'Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures', 'orgStudyIdInfo': {'id': '73982'}}, 'contactsLocationsModule': {'locations': [{'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopedics Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David Rothberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'David Rothberg', 'investigatorAffiliation': 'University of Utah'}}}}