Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-06 @ 5:28 PM
Study NCT ID:
NCT04181528
Status:
UNKNOWN
Last Update Posted:
2019-11-29
First Post:
2019-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Anatomically Aligned Versus Conventional in Unilateral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-11-26', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Western Ontario and McMaster Universities Index(WOMAC index)', 'timeFrame': 'hange from baseline score to score of postoperative1 year'}], 'secondaryOutcomes': [{'measure': 'Change in Knee Society Score', 'timeFrame': 'Change from baseline score to score of postoperative1 year'}, {'measure': 'Change in Range of Motion', 'timeFrame': 'Change from baseline Range of Motion at postoperative1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Anatomically Aligned Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': "Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith \\& Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo. The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith \\& Nephew). This study is a randomized controlled study in patients undergoing unilateral total knee arthroplasty. A patient will undergo unilateral TKA with anatomically aligned or conventional TKA implant. The implant is determined using a random number table. Radiologic parameter, patients preference and clinical results was investigated in patients who received unilateral TKA during minimum 2 year follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for bilateral total knee arthroplasty\n* having medicare insurance\n\nExclusion Criteria:\n\n* Rheumatoid arthritis\n* Other inflammatory arthritis\n* Crystal-induced arthritis\n* Septic arthritis\n* Neuropsychiatric patients\n* Previous knee operation history\n* Neuropsychiatric patients\n* Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)\n* Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)\n* Severe obese patients (BMI ≥ 40)'}, 'identificationModule': {'nctId': 'NCT04181528', 'briefTitle': 'A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'Anatomically aligned TKRA3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anatomically aligned total knee arthroplasty', 'description': 'Use anatomically aligned TKA implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith \\& Nephew) in patients undergoing unilateral TKA', 'interventionNames': ['Device: Total knee arthroplasty implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventaional total knee arthroplasty', 'description': 'Use conventional TKA implant (Legion total knee system, JII-BCS, Smith \\& Nephew) in patients undergoing unilateral TKA', 'interventionNames': ['Device: Total knee arthroplasty implant']}], 'interventions': [{'name': 'Total knee arthroplasty implant', 'type': 'DEVICE', 'description': 'In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table', 'armGroupLabels': ['Anatomically aligned total knee arthroplasty', 'Conventaional total knee arthroplasty']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yong In, MD, PhD', 'role': 'CONTACT', 'email': 'iy1000@catholic.ac.kr', 'phone': '821090445228'}, {'name': 'Mansoo Mansoo, MD, PhD', 'role': 'CONTACT', 'email': 'kms3779@naver.com', 'phone': '821072333875'}], 'overallOfficials': [{'name': 'Yong In, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "the Catholic Univerisity of Korea Seoul St Mary's hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yong In', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}