Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT02136251
Status:
WITHDRAWN
Last Update Posted:
2023-08-14
First Post:
2014-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding was not obtained to complete study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2015-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2014-05-08', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of lower incidence of glenoid loosening and absence of radiolucent lines confirmed by CT and radiographs.', 'timeFrame': '5 years after surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Shoulder Arthroplasty', 'Glenoid anchor peg component fixation', 'Autologous bone grafting'], 'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.', 'detailedDescription': 'This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Orthopaedic Surgery clinic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago.\n\nExclusion Criteria:\n\n* unable to comprehend the consent form information\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT02136251', 'acronym': 'Glenoid', 'briefTitle': 'Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Five Year Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.', 'orgStudyIdInfo': {'id': '0067-14-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'shoulder replacement', 'description': 'Subjects who had shoulder replacement surgery at The University of Nebraska and The Nebraska Medical Center at least 5 or more years ago and autologous bone graft around the anchor-peg glenoid prosthesis was used.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthew Teusink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}