Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT02683460
Status:
UNKNOWN
Last Update Posted:
2016-02-17
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2016-02-04', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale', 'timeFrame': 'Change from preoperative score to postoperative 2 years'}, {'measure': 'Knee Society score', 'timeFrame': 'Change from preoperative score to postoperative 2 years'}], 'secondaryOutcomes': [{'measure': "Feller's score", 'timeFrame': 'Change from preoperative score to postoperative 2 years'}, {'measure': 'Patients satisfaction using Visual Analog Score for pain', 'timeFrame': 'Change from preoperative score to postoperative 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Patella Resurfacing']}, 'descriptionModule': {'briefSummary': "This study aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.\n\nThis study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.", 'detailedDescription': "The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.\n\nPatients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index \\[WOMAC\\]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for total knee arthroplasty\n* Having medicare insurance\n\nExclusion Criteria:\n\n* Patients who are not able to cooperate\n* Serious deformity (not suitable for a standard TKA prosthesis)\n* Patellar thickness less than 18 mm\n* Prior operation involving the extensor mechanism\n* Rheumatoid arthritis\n* Severe medical disability limiting the ability to walk\n* Revision surgery\n* Knees with predominantly patellofemoral arthrosis'}, 'identificationModule': {'nctId': 'NCT02683460', 'briefTitle': 'Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial', 'orgStudyIdInfo': {'id': 'Patella resurfacing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patella resurfacing group', 'description': 'Procedure: Patellar component Resurfacing with onlay technique', 'interventionNames': ['Procedure: Patella resurfacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patella retention', 'description': 'Procedure: patellar retention Trimming of osteophytes when appropriate', 'interventionNames': ['Procedure: Patella retention']}], 'interventions': [{'name': 'Patella resurfacing', 'type': 'PROCEDURE', 'armGroupLabels': ['patella resurfacing group']}, {'name': 'Patella retention', 'type': 'PROCEDURE', 'armGroupLabels': ['patella retention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yong In, MD, PhD', 'role': 'CONTACT', 'email': 'iy1000@catholic.ac.kr', 'phone': '8290445228'}, {'name': 'Mansoo Kim, MD', 'role': 'CONTACT', 'email': 'kms3779@naver.com', 'phone': '8272333875'}], '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'}}}}