Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT04831918
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2021-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cemented Acetabular Cups Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery', 'timeFrame': '2 years Follow up', 'description': 'HHS ranges from 0 to 100, being 0 the worst and 100 the best conditions. HHS is reported as 90-100 for excellent results, 80-90 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. The outcome is considered satisfactory for values over 80'}], 'secondaryOutcomes': [{'measure': 'Radiographic evaluation and stability assessment of the implant up to 2 years FU', 'timeFrame': '6 weeks, 1 year and 2 years FU', 'description': 'Radiographic stability, radiographically detectable complications'}, {'measure': 'Clinical progression of HOOS up to 2 years FU, compared to the baseline', 'timeFrame': '6 weeks, 1 year and 2 years FU', 'description': 'Hip disability and osteoarthritis outcome score (HOOS) is a patient-reported outcome measurement, that ranges from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms'}, {'measure': 'Change in TUG from preoperative up to 2 years FU', 'timeFrame': '6 weeks, 1 year and 2 years FU', 'description': 'Timed Up and Go'}, {'measure': 'Clinical progression of HHS up to 1 year FU, compared to the baseline', 'timeFrame': '6 weeks, 1 year', 'description': 'Harris Hip Score'}, {'measure': 'Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery', 'timeFrame': '2 years FU'}, {'measure': 'Incidence of device-related AE/SAE up to 2 years of follow-up', 'timeFrame': '6 weeks, 1 year and 2 years FU', 'description': 'Adverse events and device deficiencies'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cemented acetabular cup'], 'conditions': ['Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;\n2. The patient diagnosis is one or more of the following:\n\n * Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;\n * Patient with avascular necrosis of the femoral head or fracture of the femoral neck;\n * Patient with congenital or acquired deformity;\n * Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty.\n3. The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;\n\nExclusion Criteria:\n\nThe patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:\n\n1. Acute or chronic infections, local or systemic infections;\n2. Serious muscular, neurological or vascular diseases affecting the concerned limb;\n3. Any concomitant disease and dependence that might affect the implanted prosthesis;\n4. Allergy to material;\n5. Metal-on-metal systems: patients with renal impairment.\n6. Patient's age\\<18\n7. Female patients who are pregnant, nursing, or planning a pregnancy."}, 'identificationModule': {'nctId': 'NCT04831918', 'briefTitle': 'Cemented Acetabular Cups Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Limacorporate S.p.a'}, 'officialTitle': 'A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups', 'orgStudyIdInfo': {'id': 'H-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mueller cemented cups', 'description': 'Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component.', 'interventionNames': ['Device: Mueller cemented cups']}], 'interventions': [{'name': 'Mueller cemented cups', 'type': 'DEVICE', 'description': 'Patients undergo total hip arthroplasty with the implant of Mueller cemented cups', 'armGroupLabels': ['Mueller cemented cups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38122', 'city': 'Trento', 'state': 'TN', 'country': 'Italy', 'facility': 'Ospedale San Camillo di Trento', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}], 'overallOfficials': [{'name': 'Luca Marega', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Camillo di Trento'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Limacorporate S.p.a', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}