Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-09 @ 12:46 AM
Study NCT ID:
NCT06858358
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Medial Congruent Vs. Conventional Medial Pivot TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polyethylene insert thickness', 'timeFrame': 'Perioperative/ Periprocedural', 'description': 'Insert Thickness: Measured and analyzed in millimeters'}, {'measure': 'Mechanical axis outliers', 'timeFrame': 'Perioperative/ Periprocedural', 'description': 'Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray'}], 'secondaryOutcomes': [{'measure': 'International knee documentation committe (IKDC) subjective score', 'timeFrame': '3, 6, and 12 months post-operative', 'description': 'The IKDC is a purely subjective assessment that assigns patients a functional overall rating. Three (3) categories are examined by the questionnaire: symptoms, athletic activity, and knee function. The symptoms subscale aids in evaluating issues like pain, stiffness, edema, and knee giving way.\n\nThe ICC, which varies from 0.87 to 0.98, was deemed sufficient (\\>0.70). Overall, it was discovered that the IKDC-SKF has positive test-retest reliability (Grevnerts et al. 2015). The IKDC subjective form scored acceptable for construct validity (84% confirmation of the predefined hypotheses) and responsiveness (86% confirmation of the predefined hypotheses) (van Meer et al. 2015).'}, {'measure': 'Forgotten joint score-12 (FJS-12)', 'timeFrame': '3, 6, and 12 months post-operative', 'description': 'The primary objective of the FJS-12 is to evaluate the extent to which patients "forget" their artificial joints during daily activities. A higher score indicates that the patient is less aware of their joint, suggesting better surgical outcomes and higher levels of patient satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic', 'Knee arthroplasty', 'TKA', 'ROSA'], 'conditions': ['Knee Osteoarthristis']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. It aims to assess and compare clinical and functional outcomes in patients with severe knee osteoarthritis at 3, 6, and 12 months.', 'detailedDescription': 'This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as \\>2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with severe osteoarthritis (greater than III Ahlback)\n\nExclusion Criteria:\n\nPatients who refuse participation in the study Low-grade osteoarthritis'}, 'identificationModule': {'nctId': 'NCT06858358', 'briefTitle': 'Robotic Medial Congruent Vs. Conventional Medial Pivot TKA', 'organization': {'class': 'OTHER', 'fullName': 'George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures'}, 'officialTitle': 'Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis', 'orgStudyIdInfo': {'id': 'rosa_MP_MC_3002025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant', 'interventionNames': ['Procedure: Robotic assisted total knee arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional TKA with Microport Evolution Medial-Pivot', 'interventionNames': ['Procedure: Conventional total knee arthroplasty (cTKA)']}], 'interventions': [{'name': 'Robotic assisted total knee arthroplasty', 'type': 'PROCEDURE', 'description': '• ROSA RATKA with Zimmer Biomet Persona Medial Congruent', 'armGroupLabels': ['ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant']}, {'name': 'Conventional total knee arthroplasty (cTKA)', 'type': 'PROCEDURE', 'description': 'cTKA with Microport Evolution Medial-Pivot', 'armGroupLabels': ['Conventional TKA with Microport Evolution Medial-Pivot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400664', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Razvan M Melinte, MD, PhD', 'role': 'CONTACT', 'email': 'razvanmel@xnet.ro', 'phone': '+40 722 331 327'}], 'facility': 'MedLife Humanitas Hospital', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '407062', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Horea Benea, MD, PhD', 'role': 'CONTACT', 'email': 'programari.cluj@medicover.ro', 'phone': '+40 724 528 188'}], 'facility': 'Medicover Cluj Hospital', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Marian A Melinte', 'role': 'CONTACT', 'email': 'marianmelinte01@gmail.com', 'phone': '+40 728 923 062'}, {'name': 'Razvan M Melinte, MD, PhD', 'role': 'CONTACT', 'email': 'razvanmel@xnet.ro', 'phone': '+40 722 331 327'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, {'name': 'County Clinical Emergency Hospital Cluj-Napoca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marian Andrei Melinte', 'investigatorAffiliation': 'George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures'}}}}