Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT05969366
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2023-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-23', 'studyFirstSubmitDate': '2023-07-23', 'studyFirstSubmitQcDate': '2023-07-23', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of complication', 'timeFrame': 'minimum of 3 months follow up', 'description': 'survival study, any complications'}], 'secondaryOutcomes': [{'measure': 'risk factor of complications', 'timeFrame': 'minimum of 3 months follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty Complications']}, 'descriptionModule': {'briefSummary': 'Retrospective, single-centre study. Review of patients aged 85 and over who underwent total hip replacement between June 2015 and February 2022.\n\nThis is a femoral stem survival study with calculation of the complication rate in this population.\n\nThe study does not focus on total hip replacements in the context of trauma. The secondary endpoint was the search for complication risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '85 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any people of 85 years of more who received total hip arthroplasty with uncemented stem fully hydroxyapatitis coated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated\n\nExclusion Criteria:\n\n* trauma context\n* less than 3 month follow up\n* Any surgery of the hip as medical history'}, 'identificationModule': {'nctId': 'NCT05969366', 'briefTitle': 'Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor', 'orgStudyIdInfo': {'id': '2022PI032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem', 'interventionNames': ['Procedure: Total hip arthroplasty']}], 'interventions': [{'name': 'Total hip arthroplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Centre Chirurgical Emile Gallé', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Praticien Hospitalier', 'investigatorFullName': 'Olivier ROCHE', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}