[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"injury-leg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:injury-leg":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100544545","phase-3-thromboprophylaxis-in-lower-limb-immobilisation-100544545",false,"NCT06370273","Thromboprophylaxis in Lower Limb Immobilisation","Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.","TiLLI","Inclusion Criteria:\n\n* Age \\>\u002F= 16 years\n* Placed in temporary lower limb immobilisation (rigid cast or brace) as a result an injury that occurred within the last 7 calendar days\n\nExclusion Criteria:\n\n* Hospital admission is required direct from the emergency department, minor injuries unit, or fracture clinic setting with an expected length of stay \\>2 calendar days.\n* Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR \\\u003C20ml\u002Fmin\u002F1.73m2), hepatic failure or use of concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g. ritonavir) or active substances strongly inhibiting elimination pathways such as CYP3A4 or P-gp (such as clarithromycin, erythromycin or dronaderone) or a history of heparin induced thrombocytopenia.\n* Pregnancy, actively seeking conception, or active breastfeeding.\n* Preceding use of anticoagulant treatment for \\>3 calendar days at prophylactic or therapeutic dose.\n* Prior enrolment in the TiLLI study.\n* Non-rigid immobilisation (crepe bandage, tubigrip support, strapping).\n* Time since prescription of rigid immobilisation \\>3 calendar days\n* Co-enrolment onto a CTIMP where an anticoagulant is administered\n* People lacking the capacity to consent\n* Inability or refusal to use acceptable contraception up until after the last administration of IMP. Only applicable for women of childbearing potential who have been randomised to receive apixaban or rivaroxaban","ALL","16 Years",{"count":20,"type":21},10044,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.\n\nThe main questions it aims to answer are:\n\n* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)\n* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.\n\nParticipants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.\n\nDrug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.",[27,28],"Thrombosis","Injury Leg","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2024-11-12",{"date":37,"type":21},"2028-08-31",{"name":39,"class":40},"Queen Mary University of London","OTHER",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100492978","phase-3-po-vs-iv-antibiotics-for-the-treatment-of-infected-nonunion-of-fractures-after-fixation-100492978","NCT05699174","PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","POvIV2","Inclusion Criteria:\n\n1. 1\\. Bone fracture (proximal to and including the tarsal\u002Fmetatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.\n2. Infection as determined by either\n\n   1. FRI criteria\n   2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon\n3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks\n\nExclusion Criteria:\n\n1. Patients with a high risk of amputation based on the initial managing physician\n2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment\n3. Incarcerated or institutionalized patients\n4. Patients who are unable to return for required follow-up visits and\u002For medical co-morbidities which preclude treatment with a general anesthetic\n5. Patients with a prior history of chronic infection at the index site before fracture fixation\n6. Patients with pathological fractures from a neoplastic process\n7. History of Paget's Disease\n8. The patient, or a designated proxy, unwilling to provide consent\n9. The patient must be available for follow-up for at least 12 months following infection treatment","18 Years",{"count":52,"type":21},250,[24],"This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.",[56,57,58,28,59,60,61,62,63],"Infections","Infected Wound","Nonunion of Fracture","Amputation","Internal Fixation; Complications, Infection or Inflammation","Fracture","Lower Extremity Fracture","Antibiotic Side Effect","2026-06-09",{"date":66,"type":33},"2026-06-11",{"date":68,"type":33},"2023-05-30",{"date":70,"type":21},"2028-09-29",{"name":72,"class":40},"Major Extremity Trauma Research Consortium",13]