Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT07207005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2036-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2036-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femoral head penetration into the acetabulum', 'timeFrame': 'Year 5', 'description': 'Femoral head penetration into the acetabulum will be mesaured in mm/year, based on a hip X-ray and PolyWare® software, Rev 8, Draftware Inc, North Webster, IN, USA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Arthroplasty Insert'], 'conditions': ['Hip Arthroplasty Replacement']}, 'descriptionModule': {'briefSummary': "In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery.\n\nThe NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert.\n\nTo address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation.\n\nA new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance.\n\nIn the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene.\n\nNevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately.\n\nIn this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.", 'detailedDescription': "In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that total hip arthroplasty or Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery.\n\nTHR involves replacing worn and damaged areas of cartilage in the hip with artificial parts of similar shape and size. A total hip replacement consists of two parts:\n\n* A part designed to replace the head of the femur: a spherical prosthesis mounted on a stem that is inserted into the femur;\n* A part designed to replace the acetabulum: the acetabular cup. There are single-mobility cups and double-mobility cups, where an insert is positioned on the metal head inside a single-mobility cup. Introduced in the 1960s by Sir John Charnley, UHMWPE (Ultra High Molecular Weight Polyethylene) remains the most widely used material for inserts in 2024.\n\nThe NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert.\n\nTo address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation.\n\nA new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance.\n\nIn the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene.\n\nNevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately.\n\nIn this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.\n\nIn the principal investigator's current practice, prostheses with conventional PE inserts are used for patients aged 70 or over, while prostheses with highly cross-linked PE inserts are used for patients under 70. However, this age-based choice is modulated favourably or unfavourably by two other parameters: the patient's medical history and general condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, aged between 55 and 80.\n* Patient with a life expectancy \\> 5 years at the time of inclusion.\n* Patient scheduled to undergo primary total hip arthroplasty with a dual-mobility cup prosthesis.\n* Patient affiliated with or beneficiary of a social security scheme.\n* Patient who speaks French and has signed an informed consent form.\n\nExclusion Criteria:\n\n* Patients with a contraindication mentioned in the instructions for use of the medical device under investigation\n* Patients with an ASA score of 4\n* Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision\n* Patients participating in another clinical study whose objectives could interfere with this study'}, 'identificationModule': {'nctId': 'NCT07207005', 'acronym': 'CUPUSURE', 'briefTitle': 'Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '2024-A02615-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Highly cross-linked PE', 'description': 'The hip prosthesis will be a MOBILIT acetabular cup (Corin), MEIJE femoral stem (Corin), 28 mm diameter metal ball (Corin), and mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin).', 'interventionNames': ['Device: ECIMA CORIN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional PE', 'description': 'The hip prosthesis will be a MOBILIT (Corin) acetabular prosthesis, MEIJE (Corin) femoral stem, 28 mm diameter metal ball (Corin), and mobile cup (Corin) in conventional PE.', 'interventionNames': ['Device: CORIN']}], 'interventions': [{'name': 'ECIMA CORIN', 'type': 'DEVICE', 'description': 'Mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin).', 'armGroupLabels': ['Highly cross-linked PE']}, {'name': 'CORIN', 'type': 'DEVICE', 'description': 'Mobile cupule (Corin) is made of conventional PE', 'armGroupLabels': ['Conventional PE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'state': 'France', 'country': 'France', 'contacts': [{'name': 'Jean LANGLOIS, MD', 'role': 'CONTACT', 'email': 'jeangast@gmail.com', 'phone': '+33 6 03 29 45 33'}], 'facility': 'Hôpital Privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'JEAN LANGLOIS, MD', 'role': 'CONTACT', 'email': 'jeangast@gmail.com', 'phone': '+ 33 6 03 29 45 33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}