Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT01509859
Status:
UNKNOWN
Last Update Posted:
2012-01-13
First Post:
2012-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-12', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': 'complication', 'timeFrame': 'the patients will be measured during the hospital stay (average of 1 week) and at 6 weeks after surgery', 'description': 'complication as non union, infection, cut-out will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['proximal femur nail', 'pfna', 'intertan', 'weight bearing', 'pertrochanteric fracture', 'femur neck fracture'], 'conditions': ['Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur', 'Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur']}, 'referencesModule': {'references': [{'pmid': '16056089', 'type': 'BACKGROUND', 'citation': 'Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.'}, {'pmid': '11886906', 'type': 'BACKGROUND', 'citation': 'Sadowski C, Lubbeke A, Saudan M, Riand N, Stern R, Hoffmeyer P. Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degrees screw-plate: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):372-81.'}, {'pmid': '2302881', 'type': 'BACKGROUND', 'citation': 'Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6.'}, {'pmid': '8110516', 'type': 'BACKGROUND', 'citation': 'Gullberg B, Duppe H, Nilsson B, Redlund-Johnell I, Sernbo I, Obrant K, Johnell O. Incidence of hip fractures in Malmo, Sweden (1950-1991). Bone. 1993;14 Suppl 1:S23-9. doi: 10.1016/8756-3282(93)90345-b.'}, {'pmid': '1644453', 'type': 'BACKGROUND', 'citation': 'Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury. 1992;23(5):291-2. doi: 10.1016/0020-1383(92)90169-s.'}, {'pmid': '9531202', 'type': 'BACKGROUND', 'citation': 'Koval KJ, Sala DA, Kummer FJ, Zuckerman JD. Postoperative weight-bearing after a fracture of the femoral neck or an intertrochanteric fracture. J Bone Joint Surg Am. 1998 Mar;80(3):352-6. doi: 10.2106/00004623-199803000-00007.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.', 'detailedDescription': 'Fractures of the proximal femur and hip are relatively common injuries in adults.\n\nAccording to the Evans and the AO Classification systems, the fracture can be described as stable after reduction or not according to the direction of the fracture lines and the comminution of the medial cortex or the lateral wall of the proximal femur.\n\nBiomechanically, nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor moment arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing the lateral aspect of the head and neck to come to rest against the nail in the medullary canal.\n\nFor fractures with comminuted medial cortex or involvement of the lateral cortex (AO 2.2 - AO 3.3) it is advisable to fixate with a more stable fixation device such as intramedullary proximal femur nail Several intramedullary devices are currently in use for the treatment of the intertrochanteric fractures. In our institution, for the unstable fracture we use either one of the intramedullary devices manufactured by Synthes (Proximal femoral nail - anti-rotation = PFNA) or by Smith\\&Nephew (Trochanteric Antegrade Nail = InterTan).\n\nEach of these nails allow compression over the Nail\\\\Blade with the intramedullary stability.\n\nThere are 3 main complications in the treatment of intramedullary devices : (1) varus collapse of the head/neck, (2) uncontrolled shortening of the neck, and (3)femoral shaft fractures at the tip of the nail The InterTan, unlike other devices, allows for immediate intraoperative compression of the principal fracture fragments through linear compression combined with rotational stability secondary to its unique geometry and mechanism of action.\n\nThe mechanical stability of the fracture after the fixation is reflected by the weight bearing the patient can hold . In order to find weather there is a mechanical difference between the two devices we would like to perform a test measuring the weight bearing after fixation of intertrochanteric fractures comparing the pain and impression of mechanical stability in the two devices.\n\nThe method to test the amount of weight bearing would be using the "SmartStep gait system" TM (Andante Medical Devices Ltd), an innovative biofeedback and monitoring system that records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pertrochanteric fracture ao 2.2 and above\n* ambulatory patient, without support prior to the fall\n* minor trauma mechanism\n* without other injuries\n* operated 3 days from the injury\n\nExclusion Criteria:\n\n* dementia\n* s/p hip or knee arthroplasty\n* known osteoarthritis'}, 'identificationModule': {'nctId': 'NCT01509859', 'briefTitle': 'Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices', 'orgStudyIdInfo': {'id': '0333-11-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PFNA', 'description': 'these patients will be treated with "synthes" PFNA" device', 'interventionNames': ['Device: PFNA proximal femur nail device (Synthes)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INTERTAN', 'description': 'these patients will be treated with Smith\\&Nephew "INTERTAN" device', 'interventionNames': ['Device: INTERTAN proximal femur nail device (Smith&Nephew)']}], 'interventions': [{'name': 'PFNA proximal femur nail device (Synthes)', 'type': 'DEVICE', 'description': 'synthes "PFNA" proximal femur nail device', 'armGroupLabels': ['PFNA']}, {'name': 'INTERTAN proximal femur nail device (Smith&Nephew)', 'type': 'DEVICE', 'description': 'Smith\\&Nephew "INTERTAN" proximal femur nail device', 'armGroupLabels': ['INTERTAN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'eliezer sidon, MD', 'role': 'CONTACT', 'email': 'elisid@clalit.org.il', 'phone': '972-3523-896169'}, {'name': 'yona kosashvili, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'eliezer sidon, MD', 'role': 'CONTACT', 'email': 'elisid@clalit.org.il', 'phone': '972-523-896169'}, {'name': 'yona kosashvili, MD', 'role': 'CONTACT', 'email': 'yonako1@clalit.org.il', 'phone': '972-3-9376156'}], 'overallOfficials': [{'name': 'yona kosashvili, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}, {'name': 'eliezer sidon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior surgeon, joint arthroplasty unit, orthopedic department', 'investigatorFullName': 'yona kosashvili', 'investigatorAffiliation': 'Rabin Medical Center'}}}}