[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tibial-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tibial-fractures":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,67,104,129,155,179,203,229,258,284,308,340],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100471658","phase-4-prophylactic-antibiotic-coated-nail-to-prevent-infection-a-clinical-trial-100471658",false,"NCT05421741","Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial","Inclusion Criteria:\n\n* Patients 18 years or older\n* Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Allergy to vancomycin or gentamicin\n* Unable to speak English or Spanish\n* Pregnant and lactating women\n* Prisoner\n* Unable to follow up for 12 months","ALL","18 Years",{"count":18,"type":19},484,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.",[25,26,27],"Osteomyelitis Tibia","Tibial Fractures","Open Tibia Fracture",[29],"Antibiotic-coated nail","RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":34},"2023-05-15",{"date":38,"type":19},"2027-12",{"name":40,"class":41},"Wake Forest University Health Sciences","OTHER",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100568271","comparison-of-healing-measures-tibial-fractures-following-standard-intramedullary-nailing-or-micromotion-tibial-intramedullary-nailing-100568271","NCT06679049","Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing","Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing","Inclusion Criteria:\n\n* Age 18 - 85 years\n* Stable Tibial fracture recommended for surgical intervention\n\nExclusion Criteria:\n\n* Patients not meeting inclusion criteria\n* Unstable fracture patterns e.g. those needing a secondary intervention - masquelet\u002Fcement spacer)\n* Previously non-ambulatory patients\n* Delayed presentation of fracture (\\>4 weeks)\n* Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability\n* Patients with an achieve infection or wound at the surgical site\n* Any previous ligament or fracture surgery on the index site\n* Inflammatory rheumatic disease or other rheumatic disease-\n* Immune compromised patients (hepatitis, HIV, etc.)\n* Unwilling or unable to participate or follow study protocol","85 Years",{"count":52,"type":19},100,[54],"NA","The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.",[26],"2026-05-11",{"date":59,"type":34},"2026-05-14",{"date":61,"type":34},"2025-04-30",{"date":63,"type":19},"2026-12-01",{"name":65,"class":41},"University of Alabama at Birmingham",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100600060","smart-crutch-tips-for-guided-weight-bearing-in-patients-recovering-from-tibial-shaft-fractures-100600060","NCT07092579","Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures","Study of Individual Weight-bearing and Iterative Walking Using \"ComeBack Mobility\" Smart Crutch Tips for Mechanical Stimulation of Tibial Shaft Fracture Healing.","Inclusion Criteria:\n\n1. Signed informed consent was provided after being fully informed about participation in the study.\n2. Age: 18 to 80 years for both males and females (pre-menopausal).\n3. Body weight between 40 and 120 kg.\n4. Body Mass Index (BMI) between 18.5 and 29.9 kg\u002Fm².\n5. Diagnosed with a closed tibial shaft fracture (AO\u002FOTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.\n6. Fracture treated exclusively with intramedullary nailing and\u002For plate fixation\n7. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).\n8. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.\n9. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.\n10. Enrollment within 48 hours following surgical intervention.\n11. Alcohol consumption (up to 2-3 times per week) within acceptable limits.\n12. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.\n13. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable\n\nExclusion Criteria:\n\n1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.\n2. Fractures classified as 43-B or 43-C according to AO\u002FOTA.\n3. Chronic alcoholism (defined as \\>14 standard drinks per week for men or \\>7 for women).\n4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.\n5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.\n6. Lower-limb contractures with functional impairment of grade II or higher.\n7. Pregnancy or intention to conceive during the study period.\n8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.\n9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \\\u003C40% or with symptoms such as edema, dyspnea at rest, or orthopnea).\n10. Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ \\\u003C 60 mmHg) or hypercapnia (PaCO₂ \\> 45 mmHg), requiring oxygen support or significantly limiting physical activity.\n11. Clinically significant neurological disorders that may affect motor function, coordination, or physical activity (e.g., stroke with residual deficits, Parkinson's disease, multiple sclerosis, cerebral palsy).\n12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.\n13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).\n14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.\n15. Participation in another clinical study within the past 6 months that could affect the results of the current study.\n16. Ongoing or planned use of medications known to affect bone healing.","80 Years",{"count":76,"type":19},30,[54],"The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for tibial shaft fractures. The study will also assess how safe and practical this approach is in daily outpatient use.\n\nCan a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which leads to faster healing, earlier mobility, and better outcomes.\n\nParticipants will:\n\nUse Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend six follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.",[80,26],"Fracture Healing",[82,80,83,84,85,86,87,88,89,90,91,92],"Tibial Fracture","Intramedullary Fixation","Controlled Mechanical Loading","Weight-Bearing","Finite Element Analysis","Digital Rehabilitation","Smart Crutch Tips","Bone Union","Rehabilitation Monitoring","Lower Limb Fractures","Biofeedback Device","2026-04-11",{"date":95,"type":34},"2026-04-14",{"date":97,"type":34},"2025-10-28",{"date":99,"type":19},"2027-02-15",{"name":101,"class":102},"Comeback Mobility Inc","INDUSTRY",18,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":20,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100498162","phase-3-intramedullary-calcium-sulfate-antibiotic-depot-100498162","NCT05766670","Intramedullary Calcium Sulfate Antibiotic Depot","Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients 18 years and older\n* Type II or III open tibia fracture requiring definitive fixation with intramedullary nail\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Allergy to vancomycin or tobramycin\n* Hypercalcemia\n* Unable to speak English or Spanish\n* No email, phone, or other point of contact\n* Pregnant and lactating women\n* Prisoner",{"count":112,"type":19},497,[114],"PHASE3","The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.",[117,25,26],"Open tíbia Fracture",[119],"antibiotic depot","2025-12-11",{"date":122,"type":34},"2025-12-15",{"date":124,"type":34},"2024-04-08",{"date":126,"type":19},"2028-01",{"name":40,"class":41},10,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100440989","zimmer-natural-nail-znn-bactiguard-tibia-post-market-clinical-follow-up-study-100440989","NCT05022485","Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study","Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control","Inclusion Criteria:\n\n* Patient must be 18 or older.\n* Patient has signed IRB\u002FEC-approved informed consent (if applicable for retrospective controls, based on local requirements).\n* Patient suffered primary tibia fracture (monolateral or bilateral) at high risk of infection, eligible for fixation by intramedullary (IM) nailing (standard or suprapatellar approach) and meets at least one of the following conditions:\n\n  * Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.\n  * Delayed treatment (initial treatment by external fixation due to swelling\u002F high energy trauma followed by definitive treatment by intramedullary nail).\n  * Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).\n  * Closed fractures with severe tissue damage: Tscherne grade C2 and C3.\n* Patient:\n\n  * will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit);\n  * was treated with uncoated (conventional) titanium-alloy intramedullary tibia nail for inclusion in control group;\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent.\n* Patient is not expected to survive follow-up schedule.\n* Patient is anticipated to be non-compliant to the study protocol.\n* Patient has a mental or neurological condition or alcohol\u002Fdrug addiction that will not allow for proper informed consent and\u002For participation in follow-up program.\n* Patient is a prisoner.\n* Patient is known to be pregnant and\u002For breastfeeding.\n* Patient suffered tibia fracture that meets any of the following conditions:\n\n  * Pathologic fracture.\n  * Gustilo Type IIIC open fracture.\n  * Patient has multisegmented fracture NOT eligible for fixation by intramedullary nailing.\n  * Patients with wound closure more than 10 days after injury.\n  * Besides IM nail, patient requires additional tibia fixation by plate (additional tibia fixation by screw(s) and\u002For fibula plate fixation are allowed).\n  * Concomitant with fracture, patient suffered head injury with Abbreviated Injury Score (AIS) ≥ 3.\n* For control group:\n\n  * patient doesn't have all the minimum required data available:\n\n    1. demographic information\n    2. injury classification\n    3. FRI information\n    4. operative report and device information\n    5. radiographic analyses (until fracture healing or confirmation of non-union leading to reoperation)\n* Tibia medullary canal is obliterated by a previous fracture or tumor\\*\n* Tibia bone shaft having excessive bow or a deformity\\*\n* Lack of bone substance or bone quality, which makes stable seating of the nail implant impossible\\*\n* All concomitant diseases that can impair the operation, functioning or the success of the nail implant\\*\n* Insufficient blood circulation\\*\n* Skeletally immature patients\\*\n* Infection\\*\n\n  * ZNN Bactiguard tibia contraindication",{"count":137,"type":19},500,"OBSERVATIONAL","Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.\n\nThe secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.",[26,141],"Fracture Infection",[143,144],"intramedullary tibia nail","Bactiguard","2025-11-20",{"date":147,"type":34},"2025-11-25",{"date":149,"type":34},"2022-04-11",{"date":151,"type":19},"2027-07",{"name":153,"class":102},"Zimmer Biomet",16,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":15,"minAge":16,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":20,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":66},"100554203","blood-flow-restriction-training-in-patients-with-lower-extremity-fractures-100554203","NCT06496035","Blood Flow Restriction Training in Patients With Lower Extremity Fractures","Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures: Effect on Fracture Healing, Muscle Strength and Girth, and Return to Function","Inclusion Criteria:\n\n* Adult with closed tibial shaft fracture\n* Ability to begin physical therapy treatment within 2 weeks post-operatively\n\nExclusion Criteria:\n\n* History of osteoporosis or osteopenia\n* Impaired circulation in the limb\n* Active deep vein thrombosis\n* Clotting disorders or other elevated risk of embolism\n* Sickle cell anemia\n* Infection in extremity\n* Renal compromise\n* Severe uncontrolled hypertension (SBP\\>180)\n* Lymphedema\n* Under age 18\n* Pregnancy\n* Prisoner",true,"100 Years",{"count":165,"type":19},40,[54],"This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.",[26,169],"Lower Extremity Fracture","2025-11-18",{"date":172,"type":34},"2025-11-21",{"date":174,"type":34},"2024-11-01",{"date":176,"type":19},"2026-05-31",{"name":178,"class":41},"Denver Health and Hospital Authority",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":20,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100507605","evaluation-of-the-diagnostic-and-therapeutic-value-of-tissue-ultrafiltration-in-patients-at-risk-of-acute-compartment-syndrome-acs-100507605","NCT05889559","Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)","INCLUSION CRITERIA The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of admission by virtue of their mechanism of injury, fracture pattern, clinical signs, or need to undergo fracture fixation surgery (internal or external fixation) within 48 hours of admission. Recruitment of participants will happen during hospital admission for treatment of injury.\n\nEligible patients must meet all of the following criteria and be enrolled during one of two possible times: within 14 hours of injury, or prior to undergoing surgical intervention (internal or external fixation on the injured limb) within 48 hours of admission. Eligible patients will be:\n\n1. Between the ages of 18 and 60 years\n2. Have sustained a high-energy upper leg injury such as open or closed proximal tibial shaft fracture with displacement, comminution, or segmental pattern; proximal fibula fracture; bicondylar tibial plateau fracture; Schatzker IV medial knee fracture-dislocation; proximal leg injury due to shotgun, rifle, or other projectile, or severe crushing injury.\n3. Patient can be enrolled in the study and study procedures initiated within 14 hours of injury,\\* or be enrolled prior to undergoing urgent surgical intervention on the injured limb (defined as internal or external fixation) within 48 hours of admission.\n4. Patient (or authorized legal representative) willing to sign informed consent.\n\n   * If a patient has an eligible injury and is going to surgery within 2 hours (except for fasciotomy - which is an exclusion criteria), the patient can be enrolled and the study procedures initiated at the end of surgery. If an eligible patient is enrolled and there is no surgery anticipated within 2 hours, initiate study procedures immediately.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients not willing to participate\n2. Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)\n3. Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended\n4. Soft tissue wounds, including lacerations or abrasions, that are in a location that will interfere with safe insertion of indwelling pressure or TUF catheters (anterior - anterolateral aspect of the leg)\n5. Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).\n6. Patients with known peripheral vascular disease\n7. Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.\n8. Very low clinical concern for ACS at time of admission.","60 Years",{"count":187,"type":19},60,[54],"The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome (ACS) in adults ages 18-60 with severe proximal tibia or tibial shaft fractures.\n\nThe main questions it aims to answer are:\n\nWill intramuscular pressure (IMP) be lower in the TUF cohort compared to controls?\n\nWill the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort?\n\nAre interstitial fluid biomarkers predictive of ACS?\n\nResearchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery.\n\nParticipants will:\n\nBe enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours.\n\nReceive continuous anterior compartment pressure monitoring.\n\nUndergo standard-of-care clinical evaluation and treatment.\n\n(TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid.\n\nReturn for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes.\n\n(Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.",[191,192,26],"Acute Compartment Syndrome","Fracture, Bone","2025-08-21",{"date":195,"type":34},"2025-08-28",{"date":197,"type":34},"2024-01-01",{"date":199,"type":19},"2026-07-01",{"name":201,"class":41},"Major Extremity Trauma Research Consortium",4,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":74,"enrollmentInfo":210,"targetDuration":4,"studyType":20,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":42},"100593456","phase-3-effect-of-nsaids-on-union-opioid-utilization-and-pain-management-for-tibia-fractures-a-pragmatic-randomized-controlled-trial-100593456","NCT07006675","Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial","NSAID","Inclusion Criteria:\n\n1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.\n2. Patients 18-80 years old inclusive.\n3. Patients able to be followed at a METRC facility for at least 12 months following injury\n\nExclusion Criteria:\n\n1. Patient unable to provide informed consent\n2. Patients who are current - intravenous drug user.\n3. Patients with a history of allergy to the study drugs.\n4. Patients unable to swallow oral medications or without functioning GI tract.\n5. Patients with a history of gastrointestinal bleeds or gastric perforation.\n6. Patients with a history of stroke or heart attack.\n7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.\n8. Patients with any bleeding disorders.\n9. Patients with severe renal failure \\[GFR:\\\u003C30\\]. Patients with moderate renal failure \\[GFR: 30-59\\] may participate in the study at a modified dose \\[see section 8.6 for defined modified dose\\].\n10. Patients undergoing daily treatment with systemic glucocorticoids before surgery.\n11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.\n12. Patients with a GCS \\\u003C15 at discharge.\n13. Patients with a closed head injury that precludes NSAIDS.\n14. Patients who are pregnant or lactating at time of screening\n15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.",{"count":211,"type":19},1000,[114],"Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.",[26,215],"Pain",[217,218,219,220,208],"Ibuprofen","Pain Management","Tibia Fracture","IM Nail Fixation","2025-05-27",{"date":223,"type":34},"2025-06-05",{"date":225,"type":34},"2021-05-26",{"date":227,"type":19},"2027-03",{"name":201,"class":41},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":15,"minAge":237,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":20,"phases":240,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100299028","prosthesis-versus-osteosynthesis-in-proximal-tibia-fractures-100299028","NCT03172715","Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures","Prosthesis Versus Osteosynthesis in Treatment of Intra-articular Fractures of Proximal Tibia: A Randomized, Controlled, Trial","POSITIF","Inclusion Criteria:\n\n* Acute intra-articular proximal tibia fracture with impression of the joint cartilage (Schatzker grades II to VI)\n* Impression of tibial plateau min 2 mm\n* Intact patellar tendon\n* The patient accepts both treatment options (osteosynthesis and arthroplasty)\n\nExclusion Criteria:\n\n* Not voluntary\n* Previous arthroplasty of the knee\n* Previous fracture affecting the knee joint\n* Inability to co-operate\n* Not independent (institutionalized living before fracture)\n* Severe osteoarthritis (Kellgren-Lawrence grade 4)\n* Open fracture (Gustilo grade 2 or over)\n* Progressive metastatic malign disease\n* Multiple fractures requiring operative treatment\n* Severe soft tissue injury around the knee (Tscherne classification grade 3)\n* Avulsion fracture of the patellar tendon or concomitant patellar tendon tear\n* Inability to walk before fracture\n* Severe medical comorbidities\n* Body Mass Index over 40\n* Unacceptably high risk of surgery due to severe medical comorbidities\n* Significant arterial or nerve trauma\n* Severe substance abuse","65 Years",{"count":239,"type":19},98,[54],"The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.",[26],[244,245,246,247],"Open reduction internal fixation","Arthroplasty","Surgery","Randomized controlled trial","2024-08-21",{"date":250,"type":34},"2024-08-22",{"date":252,"type":34},"2018-01-09",{"date":254,"type":19},"2029-06",{"name":256,"class":41},"Central Finland Hospital District",8,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":15,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":66},"100554794","management-of-closed-diaphyseal-displaced-leg-fractures-in-children-and-adolescents-100554794","NCT06503718","Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents","Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents: Should Osteosynthesis Be Favored From the Start?","FFD","Inclusion Criteria:\n\n* Minor subject (under 18 years old)\n* Subject treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months\n* Absence of written opposition in the medical file of the subject (and\u002For their legal representative if applicable) to the reuse of their data for scientific research purposes.\n\nExclusion criteria:\n\n* Presence of opposition from the subject (and\u002For their legal representative if applicable) to the reuse of their data for scientific research purposes.\n* Non-displaced and\u002For displaced fracture not located at the level of the tibial diaphysis\n* Open fracture\n* Incomplete or unusable file","1 Year","17 Years",{"count":269,"type":19},130,"Most displaced tibial shaft fractures in pediatric patients have traditionally been treated after reduction by cast immobilization with good long-term results. Recently, there has been a growing trend towards surgical intervention by osteosynthesis from the outset. This study aims to describe the results of orthopedic treatment and osteosynthesis from the outset.",[26],[26,273,274],"Osteosynthesis, Fracture","Closed Fracture","2024-07-09",{"date":277,"type":34},"2024-07-16",{"date":279,"type":34},"2024-04-03",{"date":281,"type":19},"2024-12-31",{"name":283,"class":41},"University Hospital, Strasbourg, France",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":299,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":66},"100553840","results-of-cross-leg-free-vascularized-fibular-graft-100553840","NCT06491316","Results of Cross-leg Free Vascularized Fibular Graft","Long Term Results of Cross-leg Free Vascularized Fibular Transfer for Reconstruction of Complex Post-traumatic Tibial Bone Defects: a Case Series Study","Inclusion Criteria:\n\n\\- Patients who were admitted into Assiut University Hospital, Orthopedics and Trauma Surgery department with big tibial bone defects ranging from 12 cm to 26 cm, associated with extensive soft tissue damage and poor ipsilateral blood supply confirmed by CT angiography and treated with cross-leg free vascularized fibular graft.\n\nExclusion Criteria:\n\n* Patients with bilateral extensive soft tissue damage and poor blood supply.\n* Patients with medical conditions preventing them from general anesthesia for long periods (\\>10 hours).",{"count":292,"type":19},22,"This study aims to evaluate the new technique of cross-leg vascularized fibular graft for reconstruction of post-traumatic long tibial bone defects in terms of restoring normal anatomy and function of the traumatized limb in a series of cases admitted in Assiut University hospital, Orthopedics and trauma surgery department.",[26],[296,297,298],"Cross-leg flap","Vascularized fibular transfer","Open grade III tibial fractures","NOT_YET_RECRUITING","2024-06-30",{"date":275,"type":34},{"date":303,"type":19},"2024-07-20",{"date":305,"type":19},"2024-10-30",{"name":307,"class":41},"Assiut University",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":316,"targetDuration":317,"studyType":138,"phases":4,"briefSummary":318,"conditions":319,"keywords":327,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":66},"100550779","knee-osteoarthritis-in-the-region-of-norrbotten-100550779","NCT06451510","Knee Osteoarthritis in the Region of Norrbotten","Knee Osteoarthritis in the Region of Norrbotten (KORN)","KORN","Inclusion Criteria:\n\n* Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015\n\nExclusion Criteria:\n\n* Death without bilateral weighted X-ray minimum 5 years post injury\n* Open growth plate in distal femur and\u002For proximal tibia\n* Extraarticular or isolated eminentia fracture\n* OA prior to injury\n* Having a rheumatic disorder involving joints\n* Earlier and\u002For later severe injury to the index knee\n* Having cognitive disorders disqualifying from the study",{"count":137,"type":19},"10 Years","The goal of this observational study is to assess the prevalence of radiographic knee osteoarthritis and to report medium and long term functional outcomes secondary to tibia plateau fractures. The second aim was to investigate whether there were any risk factors associated with these outcomes.",[320,321,322,323,26,324,325,326],"Osteoarthritis","Knee Injuries","Knee Osteoarthritis","Tibial Plateau Fractures","Patient Satisfaction","Quality of Life","Complication of Treatment",[320,328,329,330,245],"Knee","Tibial plateau fracture","Outcome","2024-06-17",{"date":333,"type":34},"2024-06-18",{"date":335,"type":34},"2020-09-01",{"date":337,"type":19},"2027-12-31",{"name":339,"class":41},"Umeå University",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":15,"minAge":317,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":20,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":299,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100264601","study-of-prognostic-factors-of-the-distal-epiphysis-of-the-tibia-fracture-prognosis-100264601","NCT02723825","Study of Prognostic Factors of the Distal Epiphysis of the Tibia Fracture Prognosis","A Multi Center Study of Prognostic Factors of the Distal Epiphysis of the Tibia Fracture","Inclusion Criteria:\n\n* The fresh fractures, within 7 days\n* Closed fracture\n* Type S-H I or II\n* Unilateral limb fracture, no other parts of the fractures or damage\n* On the other side of the lower extremity was normal\n* Epiphysis is not closed and Risser sign 0-IV degrees\n* No metabolic, genetic sex diseases etc.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Old fracture, more than 8 days.\n* Open injury\n* Type S-H III or IV or V\n* Multiple fractures and injuries\n* The contralateral limb was abnormal\n* Epiphyseal closure or Risser sign V degree\n* There are metabolic or genetic diseases\n* Do not agree to sign informed consent, not on time to follow-up.","16 Years",{"count":349,"type":19},200,[54],"Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis injury, because of the complex damage mechanism and often leads to growth retardation and joint deformity, the patient's physical and mental damage larger; also epiphysis injury restoration requires higher standard and more difficult to fixed, and methods are being actively explored to improve the curative effect and prevent the sequelae. Our hospital pediatric department of orthopedics expects to conduct prospective study through multi center to study the influence of factors such as the tibia epiphysis fracture of distal injury's mechanism and initial and residual displacement and treatment etc. on patients' prognosis of late growth disorders, joint deformity and ankle function.\n\nMethods and analysis: To join the multi center research collaboration group of the south pediatric department of orthopedics (including Pediatric Department of orthopedics of Wuhan Union Hospital, Wuhan Tongji Hospital, Hunan Children's Hospital, Wuhan women and children's Hospital, Foshan Hospital of traditional Chinese medicine, Shenzhen children's Hospital, Guangzhou city women and children's Medical Center), the formation of multi center research network, writing program, including the inclusion and exclusion criteria, grouping and follow-up time, method. Participating in the working group meeting, listening to the expert's opinions to improve research programs, formulate the tracking table of distal tibial epiphyseal fracture, and starting to implement after approved by the medical ethics committee of each hospital. The hospital is responsible for supervision in the whole process of project implementation, and building the real-time reporting system, and it is the responsible person of pediatric department of orthopedics of Foshan Hospital of TCM to do the random inspection. After the completion of data collection, data entry and statistical analysis conducted by the pediatric department of orthopedics in Foshan Hospital of TCM.\n\nEthics and promotion: The research is approved by the hospital medical ethics committee of the south pediatric orthopedics multi center cooperative research group. Single blind method is performed for children in the course of the study. Research data is shared by all participating units and joints promotion of research results.\n\nRegistration: To register and update the study on the United States NIH ClinicalTrials.gov website.",[26,353],"Epiphyseal Fracture",[355,356,357,358],"Distal tibia","fractures","epiphyses","children","2016-03-24",{"date":361,"type":19},"2016-03-31",{"date":363,"type":4},"2016-03",{"date":365,"type":19},"2026-12",{"name":367,"class":41},"Foshan Hospital of Traditional Chinese Medicine"]