Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 10:33 PM
Study NCT ID:
NCT04062604
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2019-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2019-04-14', 'studyFirstSubmitQcDate': '2019-08-18', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective assessment of the lower limb function', 'timeFrame': '12 month', 'description': 'Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome'}, {'measure': 'Objective assessment of the lower limb function', 'timeFrame': '12 month', 'description': 'Physical exam'}], 'secondaryOutcomes': [{'measure': 'Subjective assessment of the lower limb function', 'timeFrame': '3, 6, 24 months', 'description': 'Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome'}, {'measure': 'Objective assessment of the lower limb function', 'timeFrame': '3, 6, 24 months', 'description': 'Physical exam'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Treatment']}, 'descriptionModule': {'briefSummary': 'The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.', 'detailedDescription': "All four questionnaires (LLTQ, LEFS LLFI-10 and LLFI) will be translated and adopted to the Polish conditions. The detailed medical/ epidemiological history will be collected in each patient. The fracture will be assessed based on the x-ray examination and will be qualified according to AO classification. NRS (Numerical Rating Scale) will be used to assess the pain intensity. SF36, QoL, CSQ, COPE and HADS questionnaire will be used to evaluate patient's the quality of life (subjective assessment). First assessment will be done before operation and then after 3, 6, 12, 24 month postoperation treatment.\n\nWith this main study, there is a plan to assess not only femur fractures patients, but the investigators would like to have addtional groups of the patients with hip and knee allopasty and knee arthroscopy with slightly different follow-up period: before the oparation, 1 and 12 month after the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients planned for the surgical interventions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Patient Informed Consent\n* Patients planned for the surgical treatment\n\nExclusion Criteria: n.a.'}, 'identificationModule': {'nctId': 'NCT04062604', 'acronym': 'ELLFF', 'briefTitle': "The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment", 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': "The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment", 'orgStudyIdInfo': {'id': 'ELLFF1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Femur fracture', 'description': 'Stabilization of femur fracture according to the AO fundation guidelines', 'interventionNames': ['Other: surgery']}, {'label': 'Hip alloplasty', 'description': 'Endoprothesis', 'interventionNames': ['Other: surgery']}, {'label': 'Knee alloplasty', 'description': 'Endoprothesis', 'interventionNames': ['Other: surgery']}, {'label': 'Knee arthroscopy', 'description': 'Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction', 'interventionNames': ['Other: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'OTHER', 'description': 'surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy', 'armGroupLabels': ['Femur fracture', 'Hip alloplasty', 'Knee alloplasty', 'Knee arthroscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marcin Bednarek', 'role': 'CONTACT'}], 'facility': 'Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'centralContacts': [{'name': 'Marcin Bednarek', 'role': 'CONTACT', 'email': 'marcin.bednarek@uj.edu.pl', 'phone': '+486030674912'}], 'overallOfficials': [{'name': 'Marcin Bednarek', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcin Bednarek', 'investigatorAffiliation': 'Jagiellonian University'}}}}