Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-09 @ 7:26 PM
Study NCT ID:
NCT04206202
Status:
UNKNOWN
Last Update Posted:
2019-12-20
First Post:
2019-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Printing Guides in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2019-12-15', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the radiological outcomes', 'timeFrame': 'Postoperative 12 months', 'description': 'The radiological outcomes include the hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA) of the patients. The data were collected to evaluate the accuracy of the 3DP-designed PSI.'}], 'secondaryOutcomes': [{'measure': 'Hospital for Special Surgery knee score (HSS)', 'timeFrame': 'Postoperative 1,6,12 months', 'description': 'Hospital for Special Surgery knee score (HSS) was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 6 aspects as pain, function, muscle force, deformity, stability, and the range of motion. The score standard had a maximum of 100 points (best possible outcome). A total score \\<60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent.'}, {'measure': 'American Knee Society knee score (AKS)', 'timeFrame': 'Postoperative 1,6,12 months', 'description': 'The AKS was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 4 aspects as pain, stability, range of motion and the function. The score standard had a maximum of 100 points (best possible outcome). A total score \\<60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.', 'detailedDescription': 'Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;\n* Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;\n* The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.\n\nExclusion Criteria:\n\n* Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;\n* Patients with traumatic arthritis and inflammatory arthritis;\n* Patients with huge bone defects around the knee\n* Patients who had active infection around the knee;\n* Patients with knee valgus deformity;\n* Patients with severe extra-articular deformity;\n* Patients who had previous knee surgery;\n* Patients who had periarticular soft tissue dysfunction and neuropathy;\n* Patients who had poor physical condition and could not withstand the operation;\n* Patients who refused to be followed.'}, 'identificationModule': {'nctId': 'NCT04206202', 'briefTitle': '3D Printing Guides in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '3DKneeGuide'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PSI group', 'description': '3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group.', 'interventionNames': ['Device: 3D-Printed Patient-Specific Intramedullary Guide']}], 'interventions': [{'name': '3D-Printed Patient-Specific Intramedullary Guide', 'type': 'DEVICE', 'description': 'The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.', 'armGroupLabels': ['PSI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'country': 'China', 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Rui He, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southwest Hospital, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of the Center for Joint Surgery', 'investigatorFullName': 'Xiaojun Duan', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}