Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 5:29 PM
Study NCT ID:
NCT04979104
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip Arthroplasty With SL Cementless
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant radiographic stability', 'timeFrame': '3 years FU', 'description': 'Radiographic implant evaluation and stability assessment of the SL Cementless Stem on collected radiographs as per clinical practice during hospitalization and routine visits.'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes', 'timeFrame': '6 weeks, 3 months, 1 year, 3 years after surgery', 'description': 'Assessment of the clinical evaluation of the SL Cemetless Stem used in real life settings over a period of 3 years through PROMs if available and medical evaluation'}, {'measure': 'Implant safety profile', 'timeFrame': '6 weeks, 3 months, 1 year, 3 years after surgery', 'description': 'Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs) at intraoperatively/discharge, 6 weeks, 3 months, 1 year, 3 years after the implant;'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cementless femoral stem', 'Hip arthroplasty'], 'conditions': ['Hip Replacement']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the clinical, radiographical and patient-reported outcomes measurements up 3 years FU and to assess the survivorship of SL Cementless Stem after partial or total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from Nemocnice Kyjov Hospital (CZ)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll patients that underwent to partial or total hip arthroplasty and implanted with SL cementless stem between Jan 2010 and Jan 2020 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice.\n\nAdditional Inclusion criteria:\n\n* Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment;\n* Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF.\n\nExclusion Criteria:\n\n* Age \\< 18 years;\n* Female patients who are pregnant, nursing, or planning a pregnancy"}, 'identificationModule': {'nctId': 'NCT04979104', 'briefTitle': 'Hip Arthroplasty With SL Cementless', 'organization': {'class': 'INDUSTRY', 'fullName': 'Limacorporate S.p.a'}, 'officialTitle': 'A Post-market Study Evaluating Clinical and Radiographic Early Outcomes pf Hip Arthroplasty With SL Cementless Stem.', 'orgStudyIdInfo': {'id': 'H-36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SL Cementless', 'description': 'Since the trial is not comparative, the only arm implies the use of the investigational device (SL cementless femoral stem)', 'interventionNames': ['Procedure: Hip arthroplasty with SL Cementless']}], 'interventions': [{'name': 'Hip arthroplasty with SL Cementless', 'type': 'PROCEDURE', 'description': 'Total or partial hip arthroplasty with implant of SL cementless femoral stem.', 'armGroupLabels': ['SL Cementless']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyjov', 'state': 'CZ Republic', 'country': 'Czechia', 'facility': 'Nemocnice Kyjov Hospital', 'geoPoint': {'lat': 49.01018, 'lon': 17.12253}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Limacorporate S.p.a', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}