Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 5:37 AM
Study NCT ID:
NCT06990594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2025-05-17', 'studyFirstSubmitQcDate': '2025-05-17', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Score (KSS)', 'timeFrame': 'At baseline, 6 months, and 12 months post-surgery', 'description': 'The KSS is a standardized assessment tool used to evaluate knee function and pain following total knee arthroplasty. It includes an objective knee score and a functional score, measuring alignment, stability, and range of motion.'}], 'secondaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': 'At baseline, 6 months, and 12 months post-surgery', 'description': 'Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess pain levels pre- and post-surgery.'}, {'measure': 'Functional Improvement', 'timeFrame': 'At baseline, 6 months, and 12 months post-surgery.', 'description': 'Functional improvement will be measured using SF-36 Health Survey, Knee Injury and Osteoarthritis Outcome Score (KOOS), and gait analysis.'}, {'measure': 'Prosthesis Positioning and Alignment', 'timeFrame': 'At baseline and 12 months post-surgery.', 'description': 'Radiographic evaluation will assess implant positioning and limb alignment.'}, {'measure': 'Surgical Complication Rate', 'timeFrame': 'At 12 months post-surgery.', 'description': 'The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical benefits of different types of total knee arthroplasty (TKA) in osteoarthritis treatment. The study aims to compare surgical outcomes, functional recovery, complication rates, and cost-effectiveness among personalized, semi-personalized, and conventional TKA in a multi-center, bidirectional cohort study.', 'detailedDescription': 'This study aims to assess the performance of personalized, semi-personalized, and conventional total knee arthroplasty (TKA) procedures across different patient groups.\n\nThis is a prospective cohort and controlled study involving 120 patients, including 40 in the experimental group receiving personalized TKA, 40 receiving semi-personalized TKA, and 40 in the control group receiving conventional TKA. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of 120 patients aged 50-80 years diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis, who require total knee arthroplasty (TKA). Participants will be recruited from multiple centers, including Beijing Tsinghua Chang Gung Hospital, Peking University Shougang Hospital, and Beijing Chaoyang Hospital. The study will compare personalized, semi-personalized, and conventional TKA procedures in terms of surgical outcomes, functional recovery, complication rates, and cost-effectiveness.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 50-80 years.\n2. Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.\n3. Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. History of prior knee surgery or knee replacement.\n2. Severe knee deformity (valgus \\>20° or varus \\>15°) or instability.\n3. Severe contracture (\\>25° flexion contracture).\n4. Undergoing total knee revision surgery.\n5. Rheumatoid arthritis diagnosis.\n6. BMI \\>35.\n7. Neuromuscular disorders affecting knee stability or gait.\n8. Pregnancy or lactation.\n9. Presence of significant comorbidities posing unacceptable risk.\n10. Active or recent severe infections or malignancy.\n11. History of drug or alcohol abuse in the past six months.'}, 'identificationModule': {'nctId': 'NCT06990594', 'briefTitle': 'A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '25034-0-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'A total of 120 participants will be enrolled, with 40 receiving total knee arthroplasty (TKA) using a personalized prosthesis, 40 receiving semi-personalized TKA, and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '102218', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tsinghua Chang Gung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Shougang Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'YujiakuoTHU', 'investigatorAffiliation': 'Beijing Tsinghua Chang Gung Hospital'}}}}