Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-31 @ 5:30 PM
Study NCT ID:
NCT05163795
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2021-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distal Femur Fracture Nonunion - Statistical Analysis Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092524', 'term': 'Femoral Fractures, Distal'}, {'id': 'D005599', 'term': 'Fractures, Ununited'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-16', 'size': 183285, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-17T14:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reoperation', 'timeFrame': 'Within 36 months after the initial trauma', 'description': 'Reoperation due to fracture nonunion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prediction', 'Distal femur fracture', 'Nonunion', 'Statistical analysis plan'], 'conditions': ['Femur Distal Fracture', 'Nonunion of Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://boneandjoint.org.uk/Article/10.1302/2633-1462.48.BJO-2023-0077.R1', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': 'Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.', 'detailedDescription': 'See attached PDF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a retrospective cohort study conducted in level 1 trauma center at the Helsinki University Hospital with a catchment population of around one million for these fractures. All patients with a distal femur fracture treated at our institution between 2009 and 2018 were screened for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 16 years\n* AO/OTA type A or C distal femur fracture\n* Fracture located on the metaphyseal area of the distal femur (square method)\n* Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate\n* Operative treatment within 1 month after trauma\n* Operative treatment between years 2009 and 2018\n\nExclusion Criteria:\n\n* Stress fracture\n* Pathological fracture\n* An epicondylar or subchondral fracture\n* A ligament sprain in distal femur\n* Treatment with a double-plating method or with both plate and nail\n* Non-surgical treatment and patients who died before the treatment\n* Treatment with an unconventional plate (other than distal femur plate)\n* Patients whose follow-up criteria not fulfilled'}, 'identificationModule': {'nctId': 'NCT05163795', 'briefTitle': 'Distal Femur Fracture Nonunion - Statistical Analysis Plan', 'organization': {'class': 'OTHER', 'fullName': 'Töölö Hospital'}, 'officialTitle': 'Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan', 'orgStudyIdInfo': {'id': 'Distal Femur Fractures - SAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lateral locking plate', 'type': 'PROCEDURE', 'description': 'Plating of the distal femur fracture with lateral locking plate.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Jan Lindahl, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Töölö Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Resident in Orthopedics and Traumatology', 'investigatorFullName': 'Heini Sainio', 'investigatorAffiliation': 'Töölö Hospital'}}}}