Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT03492320
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2018-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC)', 'timeFrame': 'From March 2013 to December 2016', 'description': 'Questionnaire'}, {'measure': 'Self-Rated Questionnaire SF36', 'timeFrame': 'From March 2013 to December 2016', 'description': 'Questionnaire'}, {'measure': 'Health Related Quality of Life (HRQoL) 15D', 'timeFrame': 'From March 2013 to December 2016', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HRQoL', 'Quality of Life', 'End Stage Osteoarthritis', 'Total Knee Arthroplasty', 'WOMAC', 'SF 36', 'Total Knee Replacement'], 'conditions': ['Knee Arthroplasty', 'Knee Arthroplasty, Total', 'Knee Replacement, Total', 'Replacement, Total Knee', 'Total Knee Replacement', 'Health-Related Quality Of Life', 'Life Quality', 'Osteoarthritis Of Knee']}, 'descriptionModule': {'briefSummary': 'To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR', 'detailedDescription': 'Total Knee Arthroplasty (TKA) remains the surgical gold standard treatment for patients suffering from end stage osteoarthritis (OA) of the knee. However, due to the high demand and scarce medical resources, the waiting time for surgery is astoundingly lengthy. Controversies are shown on numerous studies on whether physical functionality and mental status decline or remain stable over the waiting period. This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR. This was a prospective longitudinal study, involving patients with symptomatic osteoarthritis at Prince of Wales Hospital Hong Kong. This study was conducted from March 2013 to December 2016. By universal sampling, patients who had experienced symptomatic OA visiting the Li Ka Shing Orthopaedic Specialist out-patient clinic were screened by a research nurse or a research assistant based on the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosed with symptomatic osteoarthritis\n2. Enlisted on the TKA surgical waiting list\n3. Ethnic Chinese\n4. Fluent in Cantonese\n\nExclusion Criteria:\n\n1. Evidence of cognitive dysfunction like dementia\n2. Surgery scheduled within 30 days\n3. Severe co-morbidity preluding participation'}, 'identificationModule': {'nctId': 'NCT03492320', 'acronym': 'TKA HRQoL', 'briefTitle': 'Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'CUHK_2013.381'}, 'secondaryIdInfos': [{'id': 'CREC Ref. No.', 'type': 'OTHER', 'domain': 'Joint CUHK-NTEC Clinical Research Ethics Committee'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Health Quality of Life Questionnaire Assessment', 'type': 'OTHER', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Self-Rated Questionnaire SF36 and Health Related Quality of Life (HRQoL) 15D questionnaire were used as outcome measurement for functionality and disability assessment.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ki Wai Ki Wai, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Ho Ki Wai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Orthopaedics & Traumatology; Director of MSc/PgD Programme in Musculoskeletal Medicine & Rehabilitation', 'investigatorFullName': 'Dr. Ho Ki Wai', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}