Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 1:09 AM
Study NCT ID:
NCT02983357
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D012149', 'term': 'Restraint, Physical'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores.", 'timeFrame': 'Day One', 'description': 'CT'}], 'secondaryOutcomes': [{'measure': 'Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.', 'timeFrame': 'Day One', 'description': 'plain radiograph'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder Arthroplasty', 'glenohumeral arthritis'], 'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.) better functional outcomes. Investigators hypothesize that a glenoid anchor peg component fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate with excellent shoulder function. Glenoid component loosening remains a major concern following total shoulder arthroplasty and is the man reason for failure. Despite positive findings in the investigators previous study (same population at a minimum of 2 year post operative follow up), it is reasonable that loosening rates could increase with longer follow-up. This study will be a minimum of 7 year post operative follow up.', 'detailedDescription': 'Long term outcome follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. This research will be a case series study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant. Eligibility criteria are subjects,who were treated at the Department of Orthopaedic Surgery at University of Nebraska Medical Center and Nebraska Medicine, with a total shoulder replacement using an anchor peg glenoid and autologous bone grafting, and who are now at least 9 years out from surgery. Each subject will be evaluated and this will include having three plain radiographs of the operated shoulder of which 2 will be true anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films. In addition, the subject will have a computed tomographic (CT) scan, without contrast dye, to examine the shoulder. One of the study personnel will use the Constant Score and Simple Shoulder Test to obtain specific shoulder functional, motion, and strength outcomes as well as pain assessment. A patient completed questionnaire, Rand Short Form Health Survey, (Rand SF-36) will be obtained to look at association with general health status. Investigators hypothesize that there will be a low incidence of glenoid loosening with a TSA (total shoulder arthroplasty) using an anchor peg glenoid and autologous bone grafting. In addition, investigators suggest that the absence of radiolucent lines will correlate with excellent shoulder function. A study was previously completed at our facility on same population at a minimum of 2 year follow up. At that time, and despite more than 10 years of widespread clinical use, no radiographic or clinical data existed regarding this unique component type. The findings from this prior study indicated that total shoulder arthroplasty (TSA) utilizing minimal glenoid peripheral peg cement and autologous reamings placed between radial fins of the central peg allowed host bone incorporation for the central peg and that better bone incorporation imparted fewer overall peg lucencies. The study findings were accepted for presentation at The American Academy of Orthopaedic Surgeons, 2010, New Orleans. Despite these positive findings, loosening rates could increase farther out from surgery, hence the purpose for the current proposed longer follow up study which is evaluation at a minimum of 9 years post surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '44 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This research is a case series study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.\n\nExclusion Criteria:\n\n* Subjects who are unable to comprehend the consent form information. Pregnant women will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02983357', 'briefTitle': 'Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Long Term Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.', 'orgStudyIdInfo': {'id': '0435-16-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Series Study', 'description': 'Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.', 'interventionNames': ['Radiation: CT, X-Ray', 'Other: Physical assessment', 'Other: Questionnaire']}], 'interventions': [{'name': 'CT, X-Ray', 'type': 'RADIATION', 'description': '2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder.', 'armGroupLabels': ['Case Series Study']}, {'name': 'Physical assessment', 'type': 'OTHER', 'description': 'Physically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes.', 'armGroupLabels': ['Case Series Study']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement', 'armGroupLabels': ['Case Series Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Unversity of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Matthew J Teusink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}