Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-01 @ 2:08 AM
Study NCT ID:
NCT04833634
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-Up of the Prevision® Hip Stem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-05', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Descriptive Analysis of Patient characteristics', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'Age, weight, gender, date of surgery, indication for revision, comorbidities, intraoperative details'}], 'primaryOutcomes': [{'measure': 'Hip stem survival measured by Kaplan-Meier', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'The primary endpoint of the study is hip stem survival, which is a common indicator for implant performance, which can also be used for comparison with implant registry data.'}], 'secondaryOutcomes': [{'measure': 'Functional Outcome: Oxford Hip Score', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'The Oxford Hip Score is a 12-item questionnaire that assesses hip function and pain. The score ranges between 12 and 60, with a lower score indicating less disability'}, {'measure': 'Patient satisfaction with their endoprosthetic revision treatment', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'The Patients are asked to grade their level of satisfaction with the outcome of the surgery at time of follow-up, with the grades: "very dissatisfied", "dissatisfied", "satisfied", "very satisfied".\n\nThe grades may be summarized as "satisfied" vs. "dissatisfied".'}, {'measure': 'Radiological evaluation (standard x-rays): Bone healing', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'Union of the osteotomy\n\no Healing of the fracture and of the greater trochanter, if applicable'}, {'measure': 'Radiological evaluation (standard x-rays): osseointegration', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling'}, {'measure': 'Radiological evaluation (standard x-rays): radiographic loosening', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'Signs of radiographic loosening in the distal fixation zone'}, {'measure': 'Radiological evaluation (standard x-rays): stem subsidence', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'Stem subsidence from ap x-rays using landmarks of the femur (typically lesser trochanter) and of the prosthesis'}, {'measure': 'Leg length difference', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': 'Discrepancy of leg length is often considered to be a problem after total hip replacement and can adversely affect an otherwise excellent outcome and may be associated with patient dissatisfaction.'}, {'measure': 'Descriptive Analysis of (Serious) adverse events', 'timeFrame': 'One scheduled Follow-Up visit per patient, 2-7 years after initial implantation', 'description': '(Serious) adverse events that are potentially related to the Total hip arthroplasty (THA) procedure or the THA implants will be recorded. These are events as reported by the patient, observed in the follow-up examinations or taken from the patient record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arthroplasty, replacement, hip', 'implant failure', 'failed primary hip arthroplasty', 'severe bone defects', 'complex bone fractures', 'septic loosening', 'poor bone remodeling'], 'conditions': ['Periprosthetic Fracture Around Prosthetic Joint Implant', 'Aseptic Loosening of Prosthetic Joint']}, 'referencesModule': {'references': [{'pmid': '38217640', 'type': 'DERIVED', 'citation': 'Herold D, Kuttner A, Dreyer L, Eingartner C. Mid-term results of a cementless hip stem in femoral revision: how much diaphyseal press-fit do we need? Arch Orthop Trauma Surg. 2024 Apr;144(4):1813-1820. doi: 10.1007/s00402-023-05191-4. Epub 2024 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to represent the treatment reality at the study site and to draw conclusions from cases of failure or suboptimal outcome. Potential risk factors for revision surgery, suboptimal outcome or radiologic sign of loosening, bone non-union or stem subsidence will be evaluated. Next to the functional outcome, stem subsidence will be used as an important indicator for a stable fixation of the revision stem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were implanted 2-7 year before the start of the retrospective study activities.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients implanted with a Prevision® hip stem at the study site between 2014 and 2019\n* Written informed patient consent\n\nExclusion Criteria:\n\n\\- Patients \\< 18 years at surgery'}, 'identificationModule': {'nctId': 'NCT04833634', 'acronym': 'PRESPECT', 'briefTitle': 'Follow-Up of the Prevision® Hip Stem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series', 'orgStudyIdInfo': {'id': 'AAG-O-H-2008'}}, 'contactsLocationsModule': {'locations': [{'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}