Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-18 @ 12:22 PM
Study NCT ID:
NCT03668704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2018-09-13
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2018-09-10', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '% of patients with revisions', 'timeFrame': '5 years after surgery', 'description': 'To determine the revision rate in this patient population'}, {'measure': '% of patients with revisions', 'timeFrame': '7 years after surgery', 'description': 'To determine the revision rate in this patient population'}], 'primaryOutcomes': [{'measure': '% of patients with Revisions', 'timeFrame': '10 years after surgery', 'description': 'To determine the revision rate in this patient population'}], 'secondaryOutcomes': [{'measure': '% of patients with Revisions', 'timeFrame': '2 years after surgery', 'description': 'To determine the revision rate in this patient population'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'medial', 'bicompartmental', 'patellofemoral'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.', 'detailedDescription': 'The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 21 years of age who require a primary robotic-arm assisted medial bicompartmental arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.\n* Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.\n* Patient is willing to comply with follow up\n\nExclusion Criteria:\n\n* Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.\n* Patient had active infection\n* Implants were implanted without bone cement\n* Patients did not have sufficient bone stock to allow for insertion and fixation of components\n* Patient did not have sufficient soft tissue integrity to allow for stability\n* Patient had a neurological or muscular deformity that did not allow for control of the knee.'}, 'identificationModule': {'nctId': 'NCT03668704', 'briefTitle': 'Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'St. Helena Hospital Coon Joint Replacement Institute'}, 'officialTitle': 'Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty', 'orgStudyIdInfo': {'id': '003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medial Bicompartmental Knee Arthroplasty', 'description': 'Patient who have received a robotic-arm assisted medial and patellofemoral knee arthroplasty.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94574', 'city': 'St. Helena', 'state': 'California', 'country': 'United States', 'facility': 'St. Helena Hospital Coon Joint Replacement Institute', 'geoPoint': {'lat': 38.50519, 'lon': -122.47026}}], 'overallOfficials': [{'name': 'Thomas Coon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Helena Hospital Coon Joint Replacement Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Helena Hospital Coon Joint Replacement Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}