Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-27 @ 7:47 AM
Study NCT ID:
NCT06654661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measured Balance Value of the Medial Side of Knee during TKA', 'timeFrame': 'Day 1 (During TKA Procedure)', 'description': 'Measured using the 3D-printed mechanical knee balancer.'}, {'measure': 'Measured Balance Value of the Lateral Side of Knee during TKA', 'timeFrame': 'Day 1 (During TKA Procedure)', 'description': 'Measured using the 3D-printed mechanical knee balancer.'}], 'secondaryOutcomes': [{'measure': 'Range of Motion at Pre-Operative Visit', 'timeFrame': 'Baseline'}, {'measure': 'Range of Motion at Post-Operative Visit', 'timeFrame': 'Up to Year 2 Post-Procedure', 'description': 'Evaluated using chart review.'}, {'measure': 'Cases of Revision Surgery', 'timeFrame': 'Up to Year 2', 'description': 'Evaluated using chart review.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test a 3D-printed mechanical balancer in a clinical setting during surgery to further evaluate the utility of the device. This will be a pilot prospective study of 50 patients undergoing primary total knee arthroplasty. Surgeons will utilize the device intraoperatively in addition to the standard of care practices of mechanical balancing. It will not guide clinical decision making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical candidates undergoing primary TKA\n\nExclusion Criteria:\n\n* Patient is unable to provide written consent'}, 'identificationModule': {'nctId': 'NCT06654661', 'briefTitle': 'Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)', 'orgStudyIdInfo': {'id': '24-00350'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TKA Patients', 'description': 'TKA patients will undergo total knee replacement as part of standard of care. The 3D printed mechanical balancer will be used at one timepoint during surgery while the patient is under anesthesia during their scheduled TKA surgery.', 'interventionNames': ['Device: 3D-Printed Mechanical Balancer']}], 'interventions': [{'name': '3D-Printed Mechanical Balancer', 'type': 'DEVICE', 'description': 'The 3D printed mechanical balancer is a surgeon-controlled handheld intraoperative tool used that provides a quantifiable measurement of force differences on the medial and lateral sides to guide achievement of a balanced knee. It will be used at one timepoint during scheduled TKA surgery while the patient is under anesthesia. Readings will be taken at 0, 45, and 90 degrees of flexion.', 'armGroupLabels': ['TKA Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Daniel Warren', 'role': 'CONTACT', 'email': 'Daniel.waren@nyulangone.org', 'phone': '212-598-6245'}, {'name': 'Peter Walker', 'role': 'CONTACT', 'email': 'Peter.walker@nyulangone.org', 'phone': '212-598-6000'}], 'overallOfficials': [{'name': 'Peter Walker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Daniel.waren@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}