Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-26 @ 2:39 AM
Study NCT ID:
NCT06382792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D047368', 'term': 'Tumor Burden'}], 'ancestors': [{'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Osteolysis (bone stock in cm3)', 'timeFrame': 'within 3 months post operatively and up to 1 year post operatively', 'description': 'allograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up'}], 'secondaryOutcomes': [{'measure': 'Constant score', 'timeFrame': 'up to 1year post operatively', 'description': 'Shoulder functional evaluation score between 6 points (worst score) and 100 points (better score)'}, {'measure': 'Complications', 'timeFrame': 'up to 1year post operatively', 'description': '(infection, dislocation)'}, {'measure': 'Revision', 'timeFrame': 'up to 1year post operatively', 'description': 'with removal of implant, with or without re implantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Shoulder Disease']}, 'descriptionModule': {'briefSummary': 'The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).\n\nThe results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).', 'detailedDescription': 'quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery.\n\nThis is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tumors of proximal humerus\n* Malawer type I resection\n* primary reconstruction by allograft prosthetic composite\n\nExclusion Criteria:\n\n* resection and reconstruction by prosthesis alone\n* resection and reconstruction by prosthesis and cement sleeve reconstruction\n* resection and reconstruction by hemiarthroplasty\n* revision protheses.'}, 'identificationModule': {'nctId': 'NCT06382792', 'briefTitle': 'Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors', 'orgStudyIdInfo': {'id': '2024PI059'}}, 'armsInterventionsModule': {'interventions': [{'name': 'proximal humeral resection for tumor and allograft prosthetic composite reconstruction', 'type': 'PROCEDURE', 'description': 'allograft prosthetic composite'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Central Hopital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Sirveaux FRANCOIS', 'role': 'STUDY_CHAIR', 'affiliation': 'Central Hopital, Nancy France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'PEDUZZI Lisa', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}