[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tibial-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tibial-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,69,96],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100636737","magnesium-titanium-hybrid-intramedullary-nail-system-for-long-bone-fractures-100636737",false,"NCT07569575","Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures","A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Effectiveness of the Magnesium-titanium Hybrid Intramedullary Nail System in Treating Long Bone Fractures of the Extremities","Inclusion Criteria:\n\n1. Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender;\n2. Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail;\n3. Good treatment compliance, willing and able to complete follow-up and observation as required;\n4. Voluntarily participate in this trial and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or individuals with family planning during the study period;\n2. Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity;\n3. Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site;\n4. Patients with severe bone defects requiring artificial bone or autologous bone grafting;\n5. Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation;\n6. Patients without sufficient soft tissue coverage at the proposed surgical site;\n7. Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site;\n8. Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site;\n9. Patients with hypermagnesemia (serum magnesium \\> 1.25 mmol\u002FL (3.0 mg\u002FdL));\n10. Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%);\n11. Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery;\n12. Patients with previous or concurrent malignant tumors (excluding those cured and disease-free survival for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);\n13. Patients who have received radiotherapy, chemotherapy, growth factors, immunosuppressants, systemic corticosteroids, long-term (continuous use for more than 3 months) sedative-hypnotics, non-steroidal anti-inflammatory drugs, or bisphosphonates within 6 months prior to screening;\n14. Patients with constitutions allergic to the implanted materials or known allergies;\n15. Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days;\n16. Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).","ALL","18 Years","80 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed metal locked intramedullary nail in the treatment of long bone fractures of the extremities.",[27,28,29],"Tibial Fracture","Femoral Fracture","Humeral Fracture",[31,32,33,34],"Magnesium-Titanium Hybrid Intramedullary Nail","Long Bone Fractures of the Extremities","Intramedullary Nailing","Biodegradable Magnesium Implant","NOT_YET_RECRUITING","2026-04-29",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":21},"2026-05-01",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"HuaMg Perfection Med Tech (Suzhou) Co., Ltd.","INDUSTRY",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100620784","assessment-of-the-verus-frame-in-tibial-intramedullary-nailing-100620784","NCT07362121","Assessment of the Verus Frame in Tibial Intramedullary Nailing","Assessment of the Verus Frame as a Support for the Leg in Orthopaedic Surgery (Intramedullary Nailing) of Tibial Fracture in Adults. A Prospective, Single-arm, Interventional Post-market Clinical Investigation With AO Foundation Approved Acceptance Criteria and a Retrospective Registry Control Group.","Inclusion Criteria:\n\n* Tibial fracture to be operated by suprapatellar intramedullary nailing technique\n* 18-80 years old\n* Signed informed consent\n\nExclusion Criteria:\n\n* Situations where intramedullary fixation is otherwise contraindicated, e.g., active or potential infection, osteoporosis or where a patient's cooperation cannot be guaranteed.\n* Pregnancy, breastfeeding\n* Open fractures with severe soft tissue damage\n* Polytrauma\n* Previous tibia fracture",{"count":56,"type":21},25,[24],"This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during intramedullary nailing procedure, as well as safety of the device. The results will be compared to AO-approved criteria to ensure comprehensive evaluation of its new benefits, regulatory compliance, and continued clinical use. Tibial intramedullary nailing is the gold standard for tibial fracture fixation, where accurate alignment and rotation are crucial for optimal recovery and long-term outcomes.",[27],"2026-01-15",{"date":62,"type":39},"2026-01-23",{"date":41,"type":21},{"date":65,"type":21},"2027-05",{"name":67,"class":46},"Hemitec Finland Oy",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":68},"100591159","tibial-imn-vs-tibial-micromotion-imn-100591159","NCT06976801","Tibial IMN Vs. Tibial Micromotion IMN","Prospective, Randomized-control Trial Comparing Standard Intramedullary Tibial Fixation With Micromotion Tibial Intramedullary Fixation","Inclusion Criteria:\n\n1. Age 18 or older\n2. Unstable tibial fracture recommended for surgical intervention\n\nExclusion Criteria:\n\n1. Patients not meeting inclusion criteria (Stable fracture patterns)\n2. Previously non-ambulatory patients\n3. Delayed presentation of fracture (\\>4 weeks)\n4. Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability\n5. Patients with an active infection or wound at the surgical site\n6. Utilizing worker's compensation at the time of screening\n7. Any previous ligament or fracture surgery on the index site\n8. Inflammatory rheumatic disease or other rheumatic disease\n9. Immune compromised patients (hepatitis, HIV, etc.)\n10. Non-English-speaking patients\n11. Unwilling or unable to participate or follow study protocol",{"count":77,"type":21},372,[24],"Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniques to one another. There is good data supporting both the use of intramedullary fixation for tibial fractures alone, and in high-risk patient populations (open fractures, GSW tibial fractures). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.\n\nWith much of the limited existing literature on tibial nails being in very defined populations, without a strong comparison group there is no clear guidance on when the use of a micromotion device is indicated. Our approach to randomize our patients will reduce the bias that exists in the current literature and provide a robust spectrum of injuries to sub analyze and compare.\n\nObjectives Primary Objective Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.\n\nSecondary Objective(s) Compare complication rates, patient reported outcomes, range of motion, pain and radiographic\u002Fsonographic outcomes in patients treated with tibial nails.",[27],[82,83,84],"Unstable tibial fracture","intramedullary nail","micromotion tibial nail fixation","RECRUITING","2025-10-06",{"date":88,"type":39},"2025-10-09",{"date":90,"type":39},"2025-07-01",{"date":92,"type":21},"2030-12",{"name":94,"class":95},"University of Chicago","OTHER",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":68},"100600881","blood-flow-restriction-therapy-to-optimize-muscle-size-and-strength-in-recovery-from-lower-limb-fractures-100600881","NCT07103252","Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Fractures","BOOST- Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Orthopaedic Trauma","BOOST","Inclusion Criteria:\n\n1. Patients aged 19-60 who have sustained an isolated (single bone\u002Farea as per AO\u002FOTA classification) unilateral lower limb fracture of the tibia that requires a period of 6 weeks of protected weight bearing (non-weight bearing or toe touch weight bearing)\n2. Must speak English\n3. Must be able to comply with protected weight bearing instructions for at least 6 weeks\n4. Must be able to consent for inclusion into the trial\n\nExclusion Criteria:\n\n1. Patients who have sustained multiple fractures in the same limb (i.e. AO\u002FOTA 3 and 4, or 4 and 8 etc).\n2. Patients who have a neurovascular injury associated with the fracture\n3. Patients who have sustained bilateral lower limb injuries\n4. Patients aged \\\u003C19 and \\>60\n5. Patients with known peripheral vascular disease or vascular repair\n6. Patients with known coagulation disorders\n7. Patients with compartment syndrome\n8. Patients with free tissue transfer for soft tissue coverage\n9. Patients with ongoing VTE or infection in the affected limb\n10. Non-ambulatory patients\n11. Patients who are pregnant","19 Years","60 Years",{"count":107,"type":21},20,[24],"This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone). Personalized blood flow restriction therapy has shown to help people regain muscle size and strength after surgical treatment by allowing them to be able to start physiotherapy on their injured leg sooner. This study aims to evaluate the feasibility and effectiveness of personalized blood flow restriction therapy to improve thigh muscle size and strength in patients with lower limb tibia fractures which require a period of non-weightbearing.",[27],[112,113,114,115,116,117,118],"Blood Flow Restriction Therapy","Lower Extremity","Tibia","Feasibility Study","Leg Injuries","Fractures, Bone","Quadriceps Muscle","2025-08-01",{"date":121,"type":39},"2025-08-05",{"date":123,"type":21},"2025-09-01",{"date":125,"type":21},"2027-08",{"name":127,"class":95},"University of British Columbia"]