Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-28 @ 2:28 PM
Study NCT ID:
NCT03152357
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivorship data', 'timeFrame': '1 year', 'description': 'Survivorship of the implant--whether or not the patient has had a surgical revision prior to data collection.'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes', 'timeFrame': '1 year', 'description': 'Collected via questionnaires during either an in-office visit or a phone call. The questionnaires are aimed at gauging how satisfied the patient is with the function of their device, if and when they experience pain/stiffness, and if and how their activities of daily living have have been affected.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['osteoarthritis', 'total knee arthroplasty', 'TKA', 'TKR', 'patient specific', 'Conformis'], 'conditions': ['Osteoarthritis, Knee', 'Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '17403800', 'type': 'BACKGROUND', 'citation': 'Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.'}, {'pmid': '17188876', 'type': 'BACKGROUND', 'citation': 'Fitzpatrick C, FitzPatrick D, Lee J, Auger D. Statistical design of unicompartmental tibial implants and comparison with current devices. Knee. 2007 Mar;14(2):138-44. doi: 10.1016/j.knee.2006.11.005. Epub 2006 Dec 22.'}, {'pmid': '19182028', 'type': 'BACKGROUND', 'citation': 'Fitz W. Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:69-76. doi: 10.2106/JBJS.H.01448.'}, {'pmid': '1959265', 'type': 'BACKGROUND', 'citation': 'Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64.'}, {'pmid': '19844772', 'type': 'BACKGROUND', 'citation': 'Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.'}, {'pmid': '16967035', 'type': 'BACKGROUND', 'citation': 'Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate implant survivorship, patient satisfaction, and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.', 'detailedDescription': 'This study is designed to evaluate implant survivorship, patient satisfaction and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.This study is a retrospective, single-center study, with one single remote follow up contact. Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient's over 18 that have undergone surgical implantation of a ConforMIS product", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement.\n* Subject must be greater than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT03152357', 'briefTitle': 'A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Restor3D'}, 'officialTitle': 'A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® CR (Cruciate Retaining) Knee Replacement Systems', 'orgStudyIdInfo': {'id': '16-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients implanted with a ConforMIS device', 'description': 'Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement', 'interventionNames': ['Device: ConforMIS iUni, iDuo, or iTotal (CR)']}], 'interventions': [{'name': 'ConforMIS iUni, iDuo, or iTotal (CR)', 'type': 'DEVICE', 'description': 'ConforMIS iUni, iDuo, or iTotal (CR)', 'armGroupLabels': ['Patients implanted with a ConforMIS device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Preferred Orthopedics of the Palm Beaches', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}], 'overallOfficials': [{'name': 'Gregory Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JFK Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Restor3D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}