Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05114694
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2021-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Arthroscopic Partial Meniscectomy(APM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee KOOS score', 'timeFrame': 'up to 12 month', 'description': 'The KOOS was a self-administered outcome questionnaire has been validated in individuals undergoing APM surgery,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}, {'measure': 'IKDC score', 'timeFrame': 'up to 12 month', 'description': 'The IKDC was a questionnaire that has high reliability and validity for middle to older patients with a meniscal tear,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}, {'measure': 'waist circumstance', 'timeFrame': 'at baseline', 'description': 'midway between the lowest rib and the iliac crest, using an anthropometric tape'}, {'measure': 'SBP', 'timeFrame': 'at baseline', 'description': 'systolic blood pressure'}, {'measure': 'DBP', 'timeFrame': 'at baseline', 'description': 'diastolic blood pressure'}, {'measure': 'TC', 'timeFrame': 'at baseline', 'description': 'serum total cholesterol (TC)'}, {'measure': 'TG', 'timeFrame': 'at baseline', 'description': 'serum triglycerides (TG)'}, {'measure': 'LDL', 'timeFrame': 'at baseline', 'description': 'serum low-density lipoprotein cholesterol (LDL-C)'}, {'measure': 'HDL', 'timeFrame': 'at baseline', 'description': 'serum high-density lipoprotein cholesterol (HDL-C)'}, {'measure': 'FBG', 'timeFrame': 'at baseline', 'description': 'serum fast blood glucose(FBG)'}, {'measure': 'BMI', 'timeFrame': 'at baseline', 'description': 'BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m\\^2'}, {'measure': 'K-L grade', 'timeFrame': 'at baseline', 'description': 'Kellgren-Lawrence (K/L) grade'}], 'secondaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'up to 12 month', 'description': 'The KOOS subscales for pain,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}, {'measure': 'symptoms score', 'timeFrame': 'up to 12 month', 'description': 'The KOOS subscales for symptoms,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}, {'measure': 'activities of daily living score', 'timeFrame': 'up to 12 month', 'description': 'The KOOS subscales for activities of daily living,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}, {'measure': 'function in sport and recreation score', 'timeFrame': 'up to 12 month', 'description': 'The KOOS subscales for function in sport and recreation,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}, {'measure': 'knee related quality of life score', 'timeFrame': 'up to 12 month', 'description': 'The KOOS subscales for knee related quality of life,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meniscus Tear']}, 'descriptionModule': {'briefSummary': 'Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.', 'detailedDescription': 'Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Must be age between 35 and 70 years old;\n\n * Clinical diagnosis of metabolic syndrome;\n * Clinical diagnosis of degnerate meniscus tears;\n\nExclusion Criteria:\n\n* Must be able to have no acute knee injury such as car crash or acute sports injury;\n\n * Must be able to have no knee surgeries history;\n * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;\n * Must be able to have no contraindications to MRI;\n * Must be able to have no severe cardiopulmonary disease;\n * Must be able to have no musculoskeletal or neuromuscular impairments ;\n * Must be able to have good visual, hearing, or cognitive;'}, 'identificationModule': {'nctId': 'NCT05114694', 'briefTitle': 'Early Arthroscopic Partial Meniscectomy(APM)', 'organization': {'class': 'OTHER', 'fullName': "The First People's Hospital of Jingzhou"}, 'officialTitle': "Consultant of Shenzhen People's Hospital", 'orgStudyIdInfo': {'id': 'APM TIME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early APM', 'description': 'Early APM group were patients have knee syndrome within 3 to 6 months', 'interventionNames': ['Procedure: early APM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'delayed APM', 'description': 'delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months', 'interventionNames': ['Procedure: delayed APM']}], 'interventions': [{'name': 'early APM', 'type': 'PROCEDURE', 'otherNames': ['Early arthroscopic partial meniscectomy'], 'description': 'Early APM group were patients have knee syndrome within 3 to 6 months', 'armGroupLabels': ['early APM']}, {'name': 'delayed APM', 'type': 'PROCEDURE', 'otherNames': ['delayed arthroscopic partial meniscectomy'], 'description': 'delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months', 'armGroupLabels': ['delayed APM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '121000', 'city': 'Jinzhou', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Guo, Master', 'role': 'CONTACT', 'email': '373073766@qq.com', 'phone': '13897830515'}, {'name': 'Ziming Zhao, Master', 'role': 'CONTACT', 'email': 'zhzm622@163.com', 'phone': '18841609587'}, {'name': 'Shuai Li, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Lu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Jinzhou Medical University', 'geoPoint': {'lat': 41.10778, 'lon': 121.14167}}], 'centralContacts': [{'name': 'Yue Guo, Master', 'role': 'CONTACT', 'email': '373073766@qq.com', 'phone': '13897830515'}, {'name': 'Zipeng Zhou, Master', 'role': 'CONTACT', 'email': 'zhouzipeng1990@163.com', 'phone': '15841659784'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The First People's Hospital of Jingzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief residents', 'investigatorFullName': 'Hongyu Wang', 'investigatorAffiliation': "The First People's Hospital of Jingzhou"}}}}