Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-06 @ 6:07 AM
Study NCT ID:
NCT01672320
Status:
WITHDRAWN
Last Update Posted:
2013-11-05
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Robotic Total Hip 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No patients will be recruited at Massachsetts General hospital. IRB approval changed to core center.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-04', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment/questionaire HOOS', 'timeFrame': 'Pre-op, 1, 3, 5, 7, 10 years after surgery', 'description': 'Hip Disability and Osteoarthritis Outcome'}, {'measure': 'Assessment/Questionaire UCLA Activty Score', 'timeFrame': 'Pre-op, 1, 3, 5, 7, 10 years after surgery', 'description': 'Assesses level of activity'}, {'measure': 'Assessment/Questionaire EQ-5D', 'timeFrame': 'Pre-op, 1, 3, 5, 7, 10 years after surgery', 'description': 'General health and cost effective analysis'}, {'measure': 'Assessment/questionaire', 'timeFrame': 'Pre-op, 1, 3, 5, 7, 10 years after surgery', 'description': 'Hip desease specific questionaire'}, {'measure': 'Assessment/Questionaire Case Mix Indicator', 'timeFrame': 'Pre-op, 1, 3, 5, 7, 10 years after surgery', 'description': 'Identifies comorbidities'}], 'primaryOutcomes': [{'measure': 'Survivorship of Components', 'timeFrame': '10 Years', 'description': 'Defined as implant remaining in subject.'}, {'measure': 'Adverse Events', 'timeFrame': '10 Years', 'description': 'Protocol deviations, complications, "lost to follow-up"'}], 'secondaryOutcomes': [{'measure': 'Retrieval Analysis of implants from revision surgery', 'timeFrame': 'Up to 10 Years', 'description': 'When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Robotic', 'Arthroplasty', 'Total Hip Arthroplasty', 'Cup Positioning', 'Outcomes'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.\n\nThe hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults requiring a total hip arthroplasty procedure.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* 20 to 75 years of age\n* Subjects requiring primary total hip replacement\n* Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.\n* Subjects diagnosed with osteoarthritis or traumatic arthritis\n* Subjects with avascular necrosis\n* Subjects who demonstrate the ability to return for follow-up for the next 10 years\n\nExclusion Criteria:\n\n* Subjects with difficulty understanding protocol for any reason\n* Subjects with a limited life span\n* Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery\n* Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study'}, 'identificationModule': {'nctId': 'NCT01672320', 'briefTitle': 'Outcomes of Robotic Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study', 'orgStudyIdInfo': {'id': '2012P000809'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase II', 'description': 'An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients'}, {'label': 'Phase I', 'description': 'An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'MAKO Surgical Corp.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Charles R. Bragdon', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}