[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"posterior-malleolus-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:posterior-malleolus-fractures":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629945","single-window-versus-two-window-posterolateral-approach-for-malleolar-fractures-100629945",false,"NCT07481266","Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures","Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis","Inclusion Criteria:\n\n* Patients aged between 18 and 65 years.\n* Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures).\n* Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach (e.g., Bartonicek Type II, III, or IV).\n* Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol.\n\nExclusion Criteria:\n\n* Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus.\n* Persistent Syndesmotic Instability: Patients demonstrating persistent distal tibiofibular syndesmotic instability (confirmed by intraoperative hook test) after the fixation of the posterior and lateral malleoli, which inherently requires additional trans-syndesmotic fixation (e.g., syndesmotic screws or suture-button devices). This exclusion is strictly applied to eliminate methodological bias, as the experimental single-window approach intentionally restricts direct lateral access for trans-syndesmotic interventions.\n* Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes.\n* Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis.\n* Previous history of ipsilateral ankle fractures or surgeries.","ALL","18 Years","65 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this prospective clinical trial is to compare the clinical outcomes and early wound complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique (using a posterior antiglide plate) or a two-window technique (using a lateral anatomic plate). The main question the study aims to answer is whether the single-window approach reduces soft-tissue complications by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, implant irritation, and functional recovery.",[27,28,29],"Ankle Fractures","Posterior Malleolus Fractures","Lateral Malleolus Fracture",[31,32,33,34,35,36,27],"Posterolateral approach","Single-window technique","Posterior antiglide plate","Two-window technique","Wound complication","Trimalleolar fracture","RECRUITING","2026-03-18",{"date":40,"type":41},"2026-03-20","ACTUAL",{"date":43,"type":41},"2024-02-14",{"date":45,"type":21},"2027-03",{"name":47,"class":48},"muhammed kılıç","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100471041","weber-b-ankle-fractures-with-associated-posterior-malleolus-fracture-100471041","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",{"count":59,"type":21},198,[24],"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.",[28,27,63,64,65],"Syndesmotic Injuries","Patient Reported Outcome Measure","Treatment Outcome",[67,68,69,70,71,72],"Posterior malleolus fractures","Ankle factures","Weber B fractures","Syndesmotic injuries","Fixation","Randomized Controlled Trial","2024-02-27",{"date":75,"type":41},"2024-02-29",{"date":77,"type":41},"2023-03-13",{"date":79,"type":21},"2030-12-31",{"name":81,"class":48},"Haukeland University Hospital"]