Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04382118
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the correction of the deformity', 'timeFrame': 'at Baseline', 'description': 'The mechanical axis of the femur and the tibia and hence the mechanical tibiofemoral angle (MFTA) will be measured pre- and postoperatively. (the goal of the operation is a neutral alignment, MFTA angle of 0°)'}], 'secondaryOutcomes': [{'measure': 'incidence of disruptive hardware', 'timeFrame': 'at Baseline', 'description': 'Information regarding the incidence of disruptive hardware and of hardware removal operations because of this, time needed until bony union is achieved, complications, delayed and non-union rates and need of conversion to arthroplasty'}, {'measure': 'pain level', 'timeFrame': 'at Baseline', 'description': 'Information regarding pain levels measured with visual analog scale score (VAS). The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain.'}, {'measure': 'pain medication intake preoperatively and at the final follow up', 'timeFrame': 'at Baseline', 'description': 'pain medication intake preoperatively and at the final follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Closed Wedge Distal Femoral Varus Osteotomy (CWDFO)', 'Open Wedge Distal Femoral Varus Osteotomy (OWDFO)'], 'conditions': ['Valgus Malalignment of the Knee']}, 'referencesModule': {'references': [{'pmid': '37278744', 'type': 'DERIVED', 'citation': 'Ismailidis P, Schmid C, Werner J, Nuesch C, Mundermann A, Pagenstert G, Egloff C. Distal femoral osteotomy for the valgus knee: indications, complications, clinical and radiological outcome. Arch Orthop Trauma Surg. 2023 Oct;143(10):6147-6157. doi: 10.1007/s00402-023-04923-w. Epub 2023 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'This study is to analyze the indications of the two most popular techniques of distal femoral osteotomy (DFO) performed in patients with valgus malalignment and symptomatic degenerative changes in the lateral compartment of the knee and to evaluate the clinical and radiological outcome of a case series of patients who have received this operation at the Department of Orthopaedics and Traumatology and the Department of Surgery of the University Hospital Basel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who received a DFO for valgus knee arthritis at the Clinic of Orthopaedics and Traumatology at the University Hospital Basel between 1.1.2013 and 31.12.2017 will be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who received a distal femoral osteotomy (DFO) for valgus knee osteoarthritis between 1.1.2013 and 31.12.2017\n\nExclusion Criteria:\n\n* Absence of informed consent\n* Absence of X-Rays documenting the preoperative deformity or postoperative result'}, 'identificationModule': {'nctId': 'NCT04382118', 'acronym': 'Var_DFO', 'briefTitle': 'Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Var_DFO:Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome', 'orgStudyIdInfo': {'id': '2020-00108; ch20Muendermann3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OWDFO: Open Wedge Distal Femoral Varus osteotomy', 'interventionNames': ['Other: Data collection from routine medical records']}, {'label': 'CWDFO: Closed Wedge Distal Femoral Varus osteotomy', 'interventionNames': ['Other: Data collection from routine medical records']}], 'interventions': [{'name': 'Data collection from routine medical records', 'type': 'OTHER', 'description': 'Data collection from routine medical records (clinical and radiological data)', 'armGroupLabels': ['CWDFO: Closed Wedge Distal Femoral Varus osteotomy', 'OWDFO: Open Wedge Distal Femoral Varus osteotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Clinic for Orthopaedics and Traumatology, University Hospital basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Annegret Muendermann, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics and Traumatology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}