Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT03933969
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assistive Device Weaning', 'timeFrame': 'Approximately 3 months', 'description': 'Number of days to weaning from all assistive devices'}], 'secondaryOutcomes': [{'measure': 'Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively', 'timeFrame': 'Approximately 3-6 months', 'description': 'Number of days taken to achieve milestones'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Joint Arthroplasty', 'Knee and Hip']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.', 'detailedDescription': 'Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects status post total hip and total knee arthroplasty that will undergo standard inpatient and outpatient physical therapy evaluation following total joint surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient's 18 years or older\n* Patients who recently underwent a primary total hip or total knee arthroplasty\n* Patient who recently underwent a total hip or total knee revision\n\nExclusion Criteria:\n\n* Patients who lack the ability to provide informed consent\n* Patients with previous total joint replacement within the last 6 months\n* Patients with complications following surgery such as DVT/PE/Infection"}, 'identificationModule': {'nctId': 'NCT03933969', 'briefTitle': 'Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty', 'orgStudyIdInfo': {'id': '18-009437'}}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Ryan C McCoy, PT, DPT, OCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ryan C. McCoy', 'investigatorAffiliation': 'Mayo Clinic'}}}}