Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-01 @ 9:15 AM
Study NCT ID:
NCT04255966
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2020-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010014', 'term': 'Osteolysis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012213', 'term': 'Rheumatic Fever'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005271', 'term': 'Femur Head Necrosis'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score (Functional results of the operated hip) over time', 'timeFrame': 'up to five years postoperatively', 'description': 'The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time'}], 'secondaryOutcomes': [{'measure': 'Survival of the implant', 'timeFrame': 'up to five years postoperatively', 'description': 'Any removal or exchange of the acetabular cup or the polyethylene inlay is defined as revision.\n\nA removal of the stem is not evaluated as acetabular revision but will be documented and evaluated as part of postoperative complications.\n\nThe revision-free survival will be assessed using the Kaplan-Meier method.'}, {'measure': 'Quality of Life over time', 'timeFrame': 'up to five years postoperatively', 'description': 'EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems).'}, {'measure': 'Radiological Assessment: Osseointegration of the cup over time', 'timeFrame': 'at 3 months, 24 months, 5 years follow-up', 'description': 'The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for osteolysis the implant, to allow an estimation of the osseous integration and stability of the implant.'}, {'measure': 'Radiological assessment: Radiographic loosening of the cup over time', 'timeFrame': 'at 3 months, 24 months, 5 years follow-up', 'description': 'The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for and radiolucent lines around the implant, to allow an estimation of the osseous integration and stability of the implant.'}, {'measure': 'Technical problems during surgery', 'timeFrame': 'Intraoperative', 'description': 'Technical problems with instruments, implants or containers, instrument related issues'}, {'measure': 'Impingement', 'timeFrame': 'Intraoperative', 'description': 'The incidence of impingement during intraoperative mobilization is documented;'}, {'measure': 'General handling of instruments / containers', 'timeFrame': 'Intraoperative', 'description': 'Complaints or problems with the handling of instruments, implants or containers, instrument related issues'}, {'measure': 'Complications', 'timeFrame': 'up to 5 years postoperatively', 'description': 'All complications in the postoperative course are recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Revision of the acetabular implant', 'orthopaedic surgery', 'osteolysis', 'wear particles', 'cup loosening', 'malpositioned cup'], 'conditions': ['Osteolysis', 'Arthroplasty Complications', 'Instability of Prosthetic Joint', 'Degenerative Osteoarthritis', 'Rheumatic Arthritis', 'Fractures, Hip', 'Femoral Head Avascular Necrosis', 'Prosthesis Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having acute disorders of the hip, requiring primary or revision surgery, which cannot be treated by other therapies:\n\n* Degenerative osteoarthritis\n* Rheumatic arthritis\n* Fractures of the joint\n* Femoral head necrosis\n* Revision surgery where a sufficient intraoperative press-fit can be achieved', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Indication for the cementless Plasmafit® Revision Structan® Hip Endoprosthesis Cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup)\n* Written informed consent\n* Cases where a press-fit cup fixation is possible\n\nExclusion Criteria\n\n* Patients \\< 18 years\n* Pregnant patients\n* Patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically)\n* Patient has an infection in the hip joint region'}, 'identificationModule': {'nctId': 'NCT04255966', 'briefTitle': 'Plasmafit® Revision Structan® Hip Endoprosthesis Cup', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup', 'orgStudyIdInfo': {'id': 'AAG-O-H-1821'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plasmafit® Revision Structan®', 'description': 'Plasmafit® Revision Structan® Hip Endoprosthesis Cup', 'interventionNames': ['Device: Plasmafit® Revision Structan®']}], 'interventions': [{'name': 'Plasmafit® Revision Structan®', 'type': 'DEVICE', 'description': 'Plasmafit® Revision Structan® Hip Endoprosthesis Cup', 'armGroupLabels': ['Plasmafit® Revision Structan®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97074', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Orthopädische Klinik König-Ludwig-Haus', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '38124', 'city': 'Braunschweig', 'state': 'Niedersachse', 'country': 'Germany', 'facility': 'Herzogin Elisabeth Hospital', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '53113', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Gemeinschaftskrankenhaus Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Stefan Landgraeber, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Saarland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}