Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT01354535
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Types of Fixation of Vancouver B1 Periprosthetic Fractures
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 89}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-16', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TUG test score at 6 weeks post-op', 'timeFrame': '6 weeks', 'description': 'We will administer the TUG test to each patient at 6 weeks to determine if there is a difference in functional status between both groups.'}], 'secondaryOutcomes': [{'measure': 'Re-operation rates', 'timeFrame': '1 year', 'description': 'We will measure rates of re-operationin each of the treatment groups on study specific case report forms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['periprosthetic', 'femur fractures', 'Vancouver B1'], 'conditions': ['Femur Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different but standard treatments for the fixation of Vancouver B1 periprosthetic. The investigators aim to compare open reduction internal fixation using a locked plating system versus plating and strut allograft with cerclage wiring to determine which treatment results in a faster return to function as measured by the TUG test at 6 weeks post-op.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: over 18, no upper limit\n* Vancouver type B1 periprosthetic fracture\n* Fracture is amenable to either treatment group\n* Prosthesis is well fixed\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Presence of an active infection around the fracture (soft tissue or bone)\n* Loose prosthesis\n* Trauma patients with an ISS \\> 16 or associated major injuries of the lower extremities\n* Known substance abuse\n* Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support)'}, 'identificationModule': {'nctId': 'NCT01354535', 'briefTitle': 'Types of Fixation of Vancouver B1 Periprosthetic Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Isolated Locked Compression Plating Versus Cable Plating and Strut Allografts With Cerclage Wiring for Vancouver B1 Periprosthetic Femoral Fractures: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '13052011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cable plating with strut', 'description': 'The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.', 'interventionNames': ['Procedure: Cable Plating and Strut Allograft with Cerclage Wiring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isolated plating', 'description': 'A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.', 'interventionNames': ['Procedure: Isolated Locked Compression Plate']}], 'interventions': [{'name': 'Isolated Locked Compression Plate', 'type': 'PROCEDURE', 'description': 'A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.', 'armGroupLabels': ['isolated plating']}, {'name': 'Cable Plating and Strut Allograft with Cerclage Wiring', 'type': 'PROCEDURE', 'description': 'The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.', 'armGroupLabels': ['Cable plating with strut']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 1R1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Milena Vicente, RN, CCRP', 'role': 'CONTACT', 'email': 'vicentem@smh.ca', 'phone': '416-864-6060', 'phoneExt': '2608'}, {'name': 'Emil Schemitsch, MD, FRCS(C)', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aaron Nauth, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Emil Schemitsch, MD, FRCS(C)', 'role': 'CONTACT', 'email': 'schemitsche@smh.ca', 'phone': '416-864-6003'}, {'name': 'Michael McKee, MD, FRCS(C)', 'role': 'CONTACT', 'email': 'mckeem@smh.ca', 'phone': '416-864-5880'}], 'overallOfficials': [{'name': 'Emil Schemitsch, MD, FRCS(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}, {'name': 'Aaron Nauth, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}