Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01466920
Status:
UNKNOWN
Last Update Posted:
2015-04-09
First Post:
2011-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience
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': 515}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2011-11-03', 'studyFirstSubmitQcDate': '2011-11-03', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Total knee arthroplasty'], 'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The goal of this research is to fill the knowledge gap relating to why up to 20 percent of total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to answer the research question: What are the drivers of variation in the patient experience with primary (ie. not revision) TKA?', 'detailedDescription': 'Purpose: Among patients with a diagnosis of osteoarthritis and who are undergoing total knee arthroplasty:\n\n1. To identify variations in the patient experience with primary knee replacement surgery by measuring clinical outcomes, health status, and patient satisfaction; and\n2. To explore the factors contributing to good/poor clinical and patient outcomes, such as surgical factors, health system factors, socioeconomic demographic factors and psychological factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing total knee arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 19 and older\n* Primary or secondary diagnosis of osteoarthritis or inflammatory arthritis\n* Scheduled to undergo primary TKA\n* Living in British Columbia\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* Not having been diagnosed with osteoarthritis\n* Inability to complete the study questionnaires\n* Adults undergoing arthroplasty revision surgery\n* Adults undergoing bilateral knee replacements\n* Adults undergoing unicompartmental knee replacements\n* Adults whose knee replacement is due to post-traumatic deformity Contacts and Locations'}, 'identificationModule': {'nctId': 'NCT01466920', 'briefTitle': 'Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience', 'orgStudyIdInfo': {'id': 'H11-02117'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V5G 2X6', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Burnaby Hospital', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'V1Y 3H5', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Kelowna General Hospital', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V2M 1S2', 'city': 'Prince George', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University Hospital of Northern British Columbia', 'geoPoint': {'lat': 53.9166, 'lon': -122.75301}}, {'zip': 'V7C 5L9', 'city': 'Richmond', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Richmond Hospital', 'geoPoint': {'lat': 49.17003, 'lon': -123.13683}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8V3M9', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'VIHA Joint Replacement Clinic', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}], 'overallOfficials': [{'name': 'Stirling Bryan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Population and Public Health, University of British Columbia'}, {'name': 'Jennifer Davis, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Alison Dormuth', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BC Ministry of Health Services'}, {'name': 'Denise Dunton, MN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Interior Health Authority'}, {'name': 'Vivian Giglio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fraser Health Authority'}, {'name': 'Laurie Goldsmith, MSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Simon Fraser University'}, {'name': 'Val MacDonald, MSN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fraser Health Authority'}, {'name': 'Patrick McAllister, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vancouver Island Health Authority'}, {'name': 'Rick Sawatzky, PhD, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trinity Western University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}