Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
Study NCT ID:
NCT06873568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-03-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cephalic Femoral Heads Follow Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.', 'timeFrame': 'From intraoperative to 24months follow up visit'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.', 'timeFrame': 'From intraoperative to 24months follow up visit'}, {'measure': 'Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty.', 'timeFrame': 'From intraoperative to 24months follow up visit'}, {'measure': 'Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty.', 'timeFrame': '12 months follow up visit', 'description': 'Baker classification is graded from 0 to 3, where 3 is the worst case. Grade 0: no erosion Grade 1: narrowing the arthicular cartilage, no erosion Grade 2: acetabular erosion and early migration Grade 3: protrusion acetabuli'}, {'measure': 'Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads.', 'timeFrame': '24 months follow up visit', 'description': 'The Harris Hip Score goes from 0 to 100, which is the best result.'}, {'measure': 'Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.', 'timeFrame': '24 months follow up visit', 'description': 'The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome'}, {'measure': 'Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.', 'timeFrame': '24 months follow up visit', 'description': 'The pain Likert-scale is a 6-point scale:\n\n* severe and spontaneous\n* severe when walking\n* tollerable\n* occurs after activity\n* light intermittent\n* no pain'}, {'measure': 'Comparison between pre-operative and 4-month walking ability.', 'timeFrame': 'Performed at preoperative visit to 4months follow up visit', 'description': 'Functional evaluation'}, {'measure': 'Comparison between pre-operative and 4-month residential status.', 'timeFrame': 'Performed at preoperative visit and 4months follow up visit', 'description': 'Daily habit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['femoral head', 'Partial hip arthroplasty'], 'conditions': ['Hip Arthroplasty Replacement', 'Femoral Fractures']}, 'descriptionModule': {'briefSummary': 'Study design: monocentric, retrospective, observational and post-market clinical study.\n\nPurpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.', 'detailedDescription': 'The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent partial hip arthroplasty with cephalic femoral heads from 1st January 2023 onwards', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Displaced intracapsular hip fracture (Garden III-IV).\n* Subjects underwent a Unipolar Hemiarthroplasty with a Cephalic femoral head as per their Indication For Use from January 1st, 2023, onwards.\n* No concurrent joint disease at the time of the surgery.\n* Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.\n* Ability to ambulate independently with or without walking aids before surgery.\n* Subject willingness to participate.\n\nExclusion Criteria:\n\n* Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).\n* Any Cephalic femoral head contraindication for use as reported in the current Instruction For Use.\n* Pathological fracture secondary to malignant disease.\n* Subjects with rheumatoid arthritis or symptomatic osteoarthritis.\n* Previous treatment to the same hip for a fracture at the time of the surgery.\n* Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.\n* Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.\n* Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).'}, 'identificationModule': {'nctId': 'NCT06873568', 'briefTitle': 'Cephalic Femoral Heads Follow Up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Limacorporate S.p.a'}, 'officialTitle': 'A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture', 'orgStudyIdInfo': {'id': 'H-45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards.', 'description': 'The study population for this clinical investigation includes subjects who suffered from a traumatic proximal femur fracture and underwent a Unipolar hemiarthroplasty with Cephalic femoral head from January 1st, 2023, onwards. Due to the characteristics of patients who underwent this type of surgery, it is expected that a considerable number of eligible patients would be in the elderly age.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5898', 'city': 'Prešov', 'country': 'Slovakia', 'contacts': [{'name': 'Dominik Kobak', 'role': 'CONTACT', 'email': 'kobakd@fnsppresov.sk', 'phone': '051/701 1899'}], 'facility': 'University Hospital J.A. Reimana', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}], 'centralContacts': [{'name': 'Monica Novello', 'role': 'CONTACT', 'email': 'monica.novello@enovis.com', 'phone': '+39 3358162087'}, {'name': 'Francesca Citossi', 'role': 'CONTACT', 'email': 'clinicalresearch@enovis.com', 'phone': '+39 0432 945511'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Limacorporate S.p.a', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}