Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04688593
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2020-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2036-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,', 'timeFrame': '10-years', 'description': 'calculated with Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 years'}, {'measure': 'Revision rates of the MobileLink acetabular cup system shell(s) with revision for any reason as the endpoint', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 years'}, {'measure': 'Revision rates of the MobileLink acetabular cup system inserts (Ceramic, XLINKed, E-Dur) with revision for any reason as the endpoint', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 years'}, {'measure': 'Revision rates of the combined LINK hip stem(s) with revision for any reason as the endpoint', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 years'}, {'measure': 'Change of baseline hip functionality', 'timeFrame': 'pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'measured by the Harris Hip Score (HHS) (maximum 100 points, minimum 0 points, a higher score indicates a better outcome)'}, {'measure': 'Change of baseline hip functionality', 'timeFrame': 'pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'measured by the Hip disability and osteoarthritis outcome score (HOOS), (maximum 100 points, minimum 0 points, a higher score indicates a better outcome)'}, {'measure': 'Rate of complications and re-operations of the hip joint', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 year follow-up'}, {'measure': 'Rate of failed osteointegrated cups', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'radiological assessment'}, {'measure': 'Rate of failed osteointegrated stems', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'radiological assessment'}, {'measure': 'Change of postoperative cup position', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'radiological assessment'}, {'measure': 'Change of postoperative stem position', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'radiological assessment'}, {'measure': 'Occurence of heterotopic ossifications', 'timeFrame': '3 months, 1 year, 3, 5, 7 and 10 year follow-up', 'description': 'radiological assessment, classified according to Brooker'}, {'measure': 'Type and rate of complications with the used instruments related to usability and sterilization', 'timeFrame': 'intraoperatively'}, {'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint', 'timeFrame': '3 month', 'description': 'calculated with Kaplan-Meier method.'}, {'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint', 'timeFrame': '1 year', 'description': 'calculated with Kaplan-Meier method.'}, {'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint', 'timeFrame': '3 year', 'description': 'calculated with Kaplan-Meier method.'}, {'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint', 'timeFrame': '5 year', 'description': 'calculated with Kaplan-Meier method.'}, {'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint', 'timeFrame': '7 year', 'description': 'calculated with Kaplan-Meier method.'}, {'measure': 'Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint', 'timeFrame': '10 year', 'description': 'calculated with Kaplan-Meier method.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MobileLink'], 'conditions': ['Osteoarthritis, Hip', 'Hip Osteoarthritis', 'Prosthesis Survival', 'Prosthesis Failure']}, 'descriptionModule': {'briefSummary': 'The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results.\n\nThe MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis system under routine condition and to determine the satisfaction of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link\n* Age ≥ 18 years\n* Fully signed patient informed cons\n\nExclusion Criteria:\n\n* Revisions\n* Body Mass Index (BMI) ≥ 40 kg/m²\n* Patient who is foreseeable not able to understand the study and the study-related circumstances\n* Patients who is foreseeable non-compliant to the treatment and the follow-ups\n* Pregnant or breast-feeding women\n* Prisoner'}, 'identificationModule': {'nctId': 'NCT04688593', 'briefTitle': 'Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Waldemar Link GmbH & Co. KG'}, 'officialTitle': 'Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up', 'orgStudyIdInfo': {'id': 'HP15'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MobileLink', 'type': 'DEVICE', 'description': 'Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Löwe', 'role': 'CONTACT'}], 'facility': 'Lubinus Stiftung', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Kirkcaldy', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Muhammad Adeel Akhtar', 'role': 'CONTACT'}], 'facility': 'NHS FIFE Victoria Hospital', 'geoPoint': {'lat': 56.11683, 'lon': -3.15999}}], 'centralContacts': [{'name': 'Lisa Skottke, PhD', 'role': 'CONTACT', 'email': 'l.skottke@link-ortho.com', 'phone': '+494053995673'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Waldemar Link GmbH & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}