Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT05476367
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 614}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-25', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRP', 'timeFrame': 'within 7 days after surgery', 'description': 'C-reactive protein'}, {'measure': 'temperature', 'timeFrame': 'within 7 days after surgery', 'description': 'The nurses measured the body temperature by Non-contact Ear Thermometer. The temperatures were measured at 6 am, 14 pm, and 18 pm every day, and the patients were kept admitted till day 5. The highest one was chosen for analysis.'}, {'measure': 'HSS score', 'timeFrame': '6 years after surgery', 'description': 'the hospital for special surgery knee score'}, {'measure': 'KSS scores', 'timeFrame': '6 years after surgery', 'description': 'knee society score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '41198532', 'type': 'DERIVED', 'citation': 'Yu J, Mi T, Shao Z, Yan X. The Outcomes of Patients With Hyperuricemia After Total Knee Arthroplasty: A Retrospective Cohort Study. Orthop Surg. 2025 Nov 6. doi: 10.1111/os.70197. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'We identify all patients who had undergone primary total knee arthroplsty(TKA) from April 1, 2015, to March 30, 2016. Patients are grouped by uric acid level. The knee society score(KSS score) and the hospital for special surgery knee score (HSS score) before the surgery and 6 years after the surgery will be collected. Also the clinical data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients received primary TKA(totla knee arthroplasty) in our hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who had undergone primary TKA from April 1, 2015, to March 30, 2016\n\nExclusion Criteria:\n\n* (1) infection, (2) rheumatoid arthritis, (3) ankylosing spondylitis, (4) revision surgery, (5) patients with unicondylar knee replacement, (6) patients who have been diagnosed with gout or previous gouty symptoms, and (7) patients combined with preoperative redness or swelling.'}, 'identificationModule': {'nctId': 'NCT05476367', 'briefTitle': 'Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2021-0785'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with normal uric acid level', 'description': 'The uric acid level is below 420 μmol/L in men and 360 μmol/L in women'}, {'label': 'patients with high uric acid level', 'description': 'The uric acid level is higher than 420 μmol/L in men and 360 μmol/L in women.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}