Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT02854566
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periprosthetic Fractures of the Femur Treated by Osteosynthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Demographic data'}, {'measure': 'Sex', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Demographic data'}, {'measure': 'Body Mass Index', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Demographic data'}, {'measure': 'Prosthesis type', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'PTH (total hip prosthesis) or BHP (bipolar hip prosthesis)'}, {'measure': 'Type of fracture', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Type of fracture according to the Vancouver International Classification'}, {'measure': 'Femoral component', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Need for cement within the femur or not'}, {'measure': 'Time between 1st surgery and fracture', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Time between 1st surgery and fracture'}, {'measure': 'Fracture healing', 'timeFrame': '10 months after surgery', 'description': 'Healing status of the fracture (healed/not healed)'}, {'measure': 'Mortality rate', 'timeFrame': '10 months after surgery', 'description': 'Mortality rate (any causes)'}, {'measure': 'Complications rate', 'timeFrame': '10 months after surgery', 'description': 'Total complications rate (local + systemic + implant)'}, {'measure': 'ASA score', 'timeFrame': 'During surgery (up to 2 hours)', 'description': 'ASA score'}, {'measure': 'Blood loss', 'timeFrame': 'During surgery (up to 2 hours)', 'description': 'Blood loss during surgery'}], 'secondaryOutcomes': [{'measure': 'Laterality', 'timeFrame': 'Up to 2-3 days before surgery (pre-surgery radiography)', 'description': 'Prosthesis on the right or on the left side'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periprosthetic fracture of the femur', 'hip prosthesis'], 'conditions': ['Periprosthetic Fracture of the Femur']}, 'referencesModule': {'references': [{'pmid': '20809166', 'type': 'BACKGROUND', 'citation': 'Gaski GE, Scully SP. In brief: classifications in brief: Vancouver classification of postoperative periprosthetic femur fractures. Clin Orthop Relat Res. 2011 May;469(5):1507-10. doi: 10.1007/s11999-010-1532-0. No abstract available.'}, {'pmid': '24891568', 'type': 'BACKGROUND', 'citation': 'Duncan CP, Haddad FS. The Unified Classification System (UCS): improving our understanding of periprosthetic fractures. Bone Joint J. 2014 Jun;96-B(6):713-6. doi: 10.1302/0301-620X.96B6.34040.'}, {'pmid': '16365115', 'type': 'BACKGROUND', 'citation': 'Lindahl H, Malchau H, Oden A, Garellick G. Risk factors for failure after treatment of a periprosthetic fracture of the femur. J Bone Joint Surg Br. 2006 Jan;88(1):26-30. doi: 10.1302/0301-620X.88B1.17029.'}, {'pmid': '21331551', 'type': 'BACKGROUND', 'citation': 'Laurer HL, Wutzler S, Possner S, Geiger EV, El Saman A, Marzi I, Frank J. Outcome after operative treatment of Vancouver type B1 and C periprosthetic femoral fractures: open reduction and internal fixation versus revision arthroplasty. Arch Orthop Trauma Surg. 2011 Jul;131(7):983-9. doi: 10.1007/s00402-011-1272-y. Epub 2011 Feb 18.'}, {'pmid': '14765858', 'type': 'BACKGROUND', 'citation': 'Learmonth ID. The management of periprosthetic fractures around the femoral stem. J Bone Joint Surg Br. 2004 Jan;86(1):13-9. No abstract available.'}, {'pmid': '19880884', 'type': 'BACKGROUND', 'citation': 'Corten K, Vanrykel F, Bellemans J, Frederix PR, Simon JP, Broos PL. An algorithm for the surgical treatment of periprosthetic fractures of the femur around a well-fixed femoral component. J Bone Joint Surg Br. 2009 Nov;91(11):1424-30. doi: 10.1302/0301-620X.91B11.22292.'}, {'pmid': '23836241', 'type': 'BACKGROUND', 'citation': "Capello WN, D'Antonio JA, Naughton M. Periprosthetic fractures around a cementless hydroxyapatite-coated implant: a new fracture pattern is described. Clin Orthop Relat Res. 2014 Feb;472(2):604-10. doi: 10.1007/s11999-013-3137-x."}, {'pmid': '25145998', 'type': 'BACKGROUND', 'citation': 'Niikura T, Sakurai A, Oe K, Shibanuma N, Tsunoda M, Maruo A, Shoda E, Lee SY, Sakai Y, Kurosaka M. Clinical and radiological results of locking plate fixation for periprosthetic femoral fractures around hip arthroplasties: a retrospective multi-center study. J Orthop Sci. 2014 Nov;19(6):984-90. doi: 10.1007/s00776-014-0622-3. Epub 2014 Aug 22.'}, {'pmid': '25894000', 'type': 'BACKGROUND', 'citation': 'Choo SK, Kim Y, Shin MJ, Oh HK. Conservative treatment after failure of internal fixation for periprosthetic femoral fractures: a report of two cases. Arch Orthop Trauma Surg. 2015 Jun;135(6):773-9. doi: 10.1007/s00402-015-2210-1. Epub 2015 Apr 18.'}, {'pmid': '23412148', 'type': 'BACKGROUND', 'citation': 'Baba T, Kaneko K, Shitoto K, Futamura K, Maruyama Y. Comparison of therapeutic outcomes of periprosthetic femoral fracture between treatments employing locking and conventional plates. Eur J Orthop Surg Traumatol. 2013 May;23(4):437-41. doi: 10.1007/s00590-012-1005-0. Epub 2012 May 17.'}, {'pmid': '25109478', 'type': 'BACKGROUND', 'citation': 'Muller FJ, Galler M, Fuchtmeier B. Clinical and radiological results of patients treated with orthogonal double plating for periprosthetic femoral fractures. Int Orthop. 2014 Dec;38(12):2469-72. doi: 10.1007/s00264-014-2464-1. Epub 2014 Aug 12.'}, {'pmid': '24253261', 'type': 'BACKGROUND', 'citation': 'Moloney GB, Westrick ER, Siska PA, Tarkin IS. Treatment of periprosthetic femur fractures around a well-fixed hip arthroplasty implant: span the whole bone. Arch Orthop Trauma Surg. 2014 Jan;134(1):9-14. doi: 10.1007/s00402-013-1883-6. Epub 2013 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015.\n\nThe goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Periprosthetic fractures of the femur treated by osteosynthesis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis).\n\nExclusion Criteria:\n\n* Death during surgery.'}, 'identificationModule': {'nctId': 'NCT02854566', 'briefTitle': 'Periprosthetic Fractures of the Femur Treated by Osteosynthesis', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Periprosthetic Fractures of the Femur Treated by Osteosynthesis', 'orgStudyIdInfo': {'id': 'CHUB-Periprosthetic fractures'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'periprosthetic fractures of the femur', 'description': 'periprosthetic fractures of the femur treated by osteosynthesis', 'interventionNames': ['Device: osteosynthesis']}], 'interventions': [{'name': 'osteosynthesis', 'type': 'DEVICE', 'description': 'Fracture reduction and fixation with screws/plates/cables (standard of care)', 'armGroupLabels': ['periprosthetic fractures of the femur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Dragos Schiopu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}, {'name': 'Tamas Illes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Tamas Illes', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}