Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-28 @ 5:07 PM
Study NCT ID:
NCT03071250
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2017-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay', 'timeFrame': '7/1/2015 - 7/1/2016', 'description': 'Postoperative hospital length of stay'}], 'secondaryOutcomes': [{'measure': 'narcotic consumption', 'timeFrame': '7/1/2015 - 7/1/2016', 'description': '30-day postoperative narcotic consumption'}, {'measure': 'Pain scores', 'timeFrame': '7/1/2015 - 7/1/2016', 'description': 'postoperative VAS pain scores'}, {'measure': '30-day readmission', 'timeFrame': '7/1/2015 - 7/1/2016', 'description': '30-day hospital readmission following procedure'}, {'measure': 'infection', 'timeFrame': '7/1/2015 - 7/1/2016', 'description': 'Surgical site infections'}, {'measure': 'PONV', 'timeFrame': '7/1/2015 - 7/1/2016', 'description': 'postoperative nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Hip Osteoarthritis', 'Knee Arthritis', 'Hip Arthritis']}, 'descriptionModule': {'briefSummary': 'The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy.\n\nThis is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects must meet all of the inclusion and exclusion criteria to be enrolled in the study.\n\nAll men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT03071250', 'briefTitle': 'An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty', 'orgStudyIdInfo': {'id': '206501'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total knee or Hip Arthroplasty', 'type': 'PROCEDURE', 'description': 'Patients who received either a total knee or hip arthroplasty will be identified'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for MEdical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}