Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT07009912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ROSA® Knee System V1.5 Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, monocentric, cross-sectional, pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System', 'timeFrame': 'Intra-operative observations, with immediate post-operative documentation and reporting period.', 'description': 'The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.\n\nThis will occur through the reporting of adverse events that outline the details and relationship to:\n\n1. Device\n2. Procedure\n3. Instruments\n4. Cement in order to determine device-related or non-device-related complications that occur during the procedure. Thus the incidence of procedure-emergent adverse events will notify and quantify the safety of the features added to the subject device (ROSA® Knee System v1.5 System)'}], 'secondaryOutcomes': [{'measure': 'Verification and Usability of the OptimiZe Planning and Activ Track Investigational Features of the ROSA® Knee System v1.5 System', 'timeFrame': 'Intra-operative evaluation, with immediate post-operative assessment and documentation. Data and statistical analysis will take place after the recruitment period has concluded.', 'description': 'Robotic log files will be evaluated to assess the following:\n\na) The delta between the OptimiZe proposed plan and the final plan approved by the surgeon, planned and final laxities, planned and final resections thus allowing for conclusions to be drawn from objective datapoints on the verification of the OptimiZe planning feature, and its validation to execute the proposed plan.\n\nAdditionally, surgeon satisfaction with the features will be evaluated with the following questionnaire (Case Report Form), to determine usability:\n\n1. Were you able to perform tracker calibration?\n2. Were you able to complete painting?\n3. Were you able to perform the contact point step?\n4. Overall, how satisfied are you with the usability of OptimiZe to assist with planning?\n5. Overall, how satisfied are you with the usability of Activ Track to complete the resections?\n6. How likely are you to recommend The ROSA Knee System v1.5 application to a peer? Q1-4 are yes/no, Q5-6 are subjective scales with 5 answers.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthroplasty, Total', 'Robotic Surgical Procedures', 'Joint Diseases', 'Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed.\n\nThe primary objectives will be assessed by measuring:\n\n1. Intra-operative complications\n2. Verification that the device performs as intended\n3. Overall surgeon satisfaction with the instrumentation.', 'detailedDescription': "This study will involve single-arm, monocentric, cross-sectional observations conducted on the day of surgery. All assessments will take place during the pre-operative, intra-operative, and immediate postop periods on the day of surgery, with no additional follow-up beyond the procedure as robotic-assisted surgery using the current version of the robot is part of routine practice.\n\nThe safety of the system is the primary endpoint. This will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.\n\nThe secondary endpoint is defined by the usability of Zimmer Biomet ROSA® Knee System, v1.5. It will be assessed by:\n\n1. Robotic log files to assess differences in the proposed plans by the system's new features and plan approved by the surgeon, along with time spent in the planning panel.\n2. Surgeon satisfaction with the new features."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is a minimum of 18 years of age\n* Independent of study participation, patient is a candidate for primary total knee arthroplasty using commercially available and compatible implants in accordance with product labeling\n* Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form\n\nExclusion Criteria:\n\n* Patient is currently participating in any other surgical intervention studies or pain management studies\n* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)\n* Patient has previously received partial or total knee arthroplasty for the ipsilateral knee'}, 'identificationModule': {'nctId': 'NCT07009912', 'briefTitle': 'ROSA® Knee System V1.5 Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Single-arm, Monocentric, Cross-sectional, Pilot Study Evaluating Updated Features for The ROSA® Knee System, v1.5, in Patients Undergoing Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'CCA2025-20TDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Zimmer Biomet ROSA® Knee System, v1.5', 'description': 'This study will include a single-arm of patients who qualify for robotic-assisted (RA) total knee arthroplasty (TKA) with the ROSA® Knee System and are planned to receive commercially available and compatible implants.', 'interventionNames': ['Device: Total Knee Arthroplasty']}], 'interventions': [{'name': 'Total Knee Arthroplasty', 'type': 'DEVICE', 'description': 'Robotic-assisted primary total knee arthroplasty, evaluating updated features for the Zimmer Biomet ROSA® Knee System, v1.5.', 'armGroupLabels': ['Experimental: Zimmer Biomet ROSA® Knee System, v1.5']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sabine Montenegro', 'role': 'CONTACT', 'email': 'sabine.montenegro@zimmerbiomet.com', 'phone': '+61 437 814 806'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}