[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471041":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":46,"locations":54,"responsibleParty":74,"collaborators":76,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":27,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":116,"overallStatus":57,"whyStopped":27,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Fixation group","EXPERIMENTAL","Patients are placed in a prone position on the operating table. Fixation of the posterior malleolus fracture. Posterior, and\u002For lateral and medial malleolus fractures will be treated with open reduction and internal fixation. ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm. Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus. The posteromedial fragment in Mason and Molloy type 2B will be fixed with one or more screws, or plate, if this fragment is displaced more than 2 mm. A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced \\>2 mm depending on size and comminution of the fragment.\n\nThe syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suture button.",[13,14,15],"Procedure: Fixation of the posterior malleolus fractures","Procedure: Fixation of lateral and\u002For medial malleolus fractures","Procedure: Syndesmotic fixation",{"label":17,"type":18,"description":19,"interventionNames":20},"Non-fixation group","ACTIVE_COMPARATOR","Patients are placed in a supine position on the operating table. No fixation of the PMF. The PMF is reduced by ligamentotaxis. Lateral and\u002For medial malleolus fractures will be treated with ORIF if present.\n\nORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm.\n\nDeltoid ligament injuries are repaired if incarcerated between medial malleolus and talus.\n\nA Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced \\>2 mm depending on size and comminution of the fragment.\n\nThe syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suturebutton.",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Fixation of the posterior malleolus fractures","Fixation of the posterior malleolus fracture with screws and or plating.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Fixation of lateral and\u002For medial malleolus fractures","Fixation with screws and\u002For plating",[9,17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Syndesmotic fixation","Fixation of unstable syndesmosis with one or two 3.5 mm tricortical screws, or with a suture button.",[9,17],[37,41,44],{"name":38,"affiliation":39,"role":40},"Jonas M Fevang, PhD","Helse Bergen, Haukeland University Hospital","STUDY_DIRECTOR",{"name":42,"affiliation":39,"role":43},"Jostein S Nilsen, MD","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":39,"role":43},"Kristian Pilskog, MD",[47,51],{"name":42,"role":48,"phone":49,"phoneExt":27,"email":50},"CONTACT","004792226426","jostein.skorpa.nilsen@helse-bergen.no",{"name":45,"role":48,"phone":52,"phoneExt":27,"email":53},"+4798217343","kpilskog@gmail.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Haukeland University Hospital, Orthopedic department","RECRUITING","Bergen","Vestland","5021","Norway","NO",{"type":64,"coordinates":65},"Point",[66,67],5.32415,60.39299,{"lat":67,"lon":66},[70,73],{"name":42,"role":48,"phone":71,"phoneExt":27,"email":72},"+4792226426","j.skorpa@gmail.com",{"name":45,"role":48,"phone":52,"phoneExt":27,"email":53},{"type":75,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[77,79,81,84,86,88,90],{"name":78,"class":6},"University Hospital, Akershus",{"name":80,"class":6},"Ullevaal University Hospital",{"name":82,"class":83},"Helse Stavanger HF","OTHER_GOV",{"name":85,"class":6},"Alesund Hospital",{"name":87,"class":6},"Ostfold Hospital Trust",{"name":89,"class":6},"St. Olavs Hospital",{"name":91,"class":6},"Helgeland Hospital Trust","100471041","weber-b-ankle-fractures-with-associated-posterior-malleolus-fracture-100471041",false,"NCT05413707","Weber B Ankle Fractures With Associated Posterior Malleolus Fracture","Posterior Malleolus Fractures (PMF) in Weber B Ankle Fractures - Fixation Versus no Fixation - a Randomized Controlled Trial","PMFIX","Inclusion Criteria:\n\n* Posterior malleolar (PM) fracture, of Mason \\& Molly type 2A\u002F2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture\n* Posterior malleoli \\>=2 mm displaced (on CT in axial, sagital or coronal plane)\n* Patients informed, written consent\n* Age 18-65 years\n* For inclusion axial CT images are examined\n\n  * Measurements are performed 5 millimeters (mm) cranial to the tibia plafond\n  * Posterior malleolus fractures involving less than 40% of the fibular notch are included.\n\nExclusion Criteria:\n\n* Non-compliant patient, i.e.: dementia, alcohol- or substance abuse\n* ASA-4 patients\n* Known congenital bone decease\n* Pathological fractures\n* Immunocompromised patients\n* Tourists or patients on a short-term work\u002Fstudy permit\n* Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction\n* Poor controlled diabetes\n* Patients with known arterial insufficiency\n* Open fractures\n* Severely traumatized patients (ISS\\>16)\n* Patient declines to participate in study","ALL","18 Years","65 Years",{"count":104,"type":105},198,"ESTIMATED","INTERVENTIONAL",[108],"NA","Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF.\n\nThrough a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients.\n\nMason and Molly type 2A and 2B fractures will be included in the study.",[111,112,113,114,115],"Posterior Malleolus Fractures","Ankle Fractures","Syndesmotic Injuries","Patient Reported Outcome Measure","Treatment Outcome",[117,118,119,120,121,122],"Posterior malleolus fractures","Ankle factures","Weber B fractures","Syndesmotic injuries","Fixation","Randomized Controlled Trial","2024-02-27",{"date":125,"type":126},"2024-02-29","ACTUAL",{"date":128,"type":126},"2023-03-13",{"date":130,"type":105},"2030-12-31",{"name":5,"class":6},1]