Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-31 @ 9:09 PM
Study NCT ID:
NCT01235169
Status:
UNKNOWN
Last Update Posted:
2013-03-22
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092526', 'term': 'Proximal Femoral Fractures'}], 'ancestors': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-21', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-04', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients reaching union at the 3-month and 6-month follow up', 'description': 'Proportion of patients reaching union at the 3-month and 6-month follow up will be assessed. Union is defined by both clinical evaluation-pain and weight bearing status, and radiological evaluation- three out of four cortices must be bridged as viewed on plain X-ray (AP and lateral views).'}]}, 'conditionsModule': {'conditions': ['Proximal Femur Fracture']}, 'descriptionModule': {'briefSummary': 'This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:\n\n1. Insertion an intramedullary nail (without augmentation) to the bone.\n2. insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic.\n\nThis new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate).\n\nThe investigators main goal is to evaluate the use of this surgical technique'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur.\n* Men and women above 80 years old that fuffer from fracture in the proximal femur.\n\nExclusion Criteria:\n\n* Patient can not come to the follow up clinic visits.'}, 'identificationModule': {'nctId': 'NCT01235169', 'briefTitle': 'Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'WEIL02-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proximal Femoral Nail Antirotation', 'description': 'Proximal Femoral Nail Antirotation(PFNA) with cement augmentation', 'interventionNames': ['Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation']}], 'interventions': [{'name': 'Proximal Femoral Nail Antirotation(PFNA) with cement augmentation', 'type': 'DEVICE', 'armGroupLabels': ['Proximal Femoral Nail Antirotation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Arik Tzukert, DMD', 'role': 'CONTACT', 'email': 'arik@hadassah.org.il', 'phone': '00 972 2 6776095'}], 'facility': 'Hadassah Medical Organizaton', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Yoram Weil', 'role': 'CONTACT', 'email': 'weily@hadassah.org.il', 'phone': '972-2-6776342'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}}}}