Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01973712
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2013-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periprosthetic Distal Femur Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057068', 'term': 'Periprosthetic Fractures'}, {'id': 'D000092524', 'term': 'Femoral Fractures, Distal'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rates of malunion', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'Timed Up and Go (TUG) test', 'timeFrame': '3 months', 'description': 'The TUG is a very simple timed test that was introduced in 1991 to measure mobility in the elderly. It involves documenting the time, in seconds, taken for subjects to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, and sit down again'}], 'secondaryOutcomes': [{'measure': 'Rates of re-operation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periprosthetic Fractures', 'Distal Femur Fractures']}, 'referencesModule': {'references': [{'pmid': '36197809', 'type': 'DERIVED', 'citation': 'Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.'}]}, 'descriptionModule': {'briefSummary': 'A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.\n\nOur multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.\n\nThe goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nAge 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent\n\nEXCLUSION CRITERIA:\n\nPresence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) \\> 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up'}, 'identificationModule': {'nctId': 'NCT01973712', 'briefTitle': 'Periprosthetic Distal Femur Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing', 'orgStudyIdInfo': {'id': 'PPDF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Locked Compression Plating', 'description': 'A direct lateral approach to the distal femur will be employed utilizing minimally invasive and indirect reduction techniques. After fracture reduction is achieved with the use of intra-operative fluoroscopy, a locking plate will be provisionally implanted. Following confirmation of placement, definitive fixation will follow with multiple locking screws in the distal fragment and bicortical screw fixation proximally. A standard layered closure will follow', 'interventionNames': ['Procedure: Locked Compression Plating']}, {'type': 'EXPERIMENTAL', 'label': 'Retrograde Intramedullary Nailing (RIMN)', 'description': 'The previous midline knee incision will be employed to access to the knee joint, allowing exposure of the femoral start point via the open box in the femoral component. Following reaming of the canal, an appropriately sized retrograde nail will be inserted. Intra-operative fluoroscopy will be used to confirm reduction. Both proximal and distal locking screws will be used to transfix the nail. A standard layered closure will follow.', 'interventionNames': ['Procedure: Retrograde Intramedullary Nailing (RIMN)']}], 'interventions': [{'name': 'Locked Compression Plating', 'type': 'PROCEDURE', 'armGroupLabels': ['Locked Compression Plating']}, {'name': 'Retrograde Intramedullary Nailing (RIMN)', 'type': 'PROCEDURE', 'armGroupLabels': ['Retrograde Intramedullary Nailing (RIMN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 1R6', '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, FRCAC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aaron Nauth, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael McKee, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. Michael's Hospital, Department of Orthopaedic Surgery", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Milena Vicente, RN, CCRP', 'role': 'CONTACT', 'email': 'vicentem@smh.ca', 'phone': '416-864-6060', 'phoneExt': '2608'}], 'overallOfficials': [{'name': 'Aaron Nauth, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}, {'name': 'Emil Schemitsch, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}