[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lower-extremity-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lower-extremity-fracture":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,71,102,136,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100604894","phase-3-perioperative-nutrition-optimization-for-reducing-complications-after-surgical-fracture-fixation-100604894",false,"NCT07155447","Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation","Inclusion Criteria:\n\n1. Adults age 18-55 years\n2. Open or closed fracture of the lower extremity including femur, tibia and\u002For fibula, calcaneus, talus, Lisfranc joint (OTA\u002FAO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85)\n3. Ability to begin supplementation within 72 hours of injury\n\nExclusion Criteria:\n\n1. BMI \\\u003C18.5 kg\u002Fm 2 (underweight) or BMI \\> 45 kg\u002Fm 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition\n2. Non-ambulatory prior to injury\n3. Currently pregnant\n4. Medical contraindication to CEAA supplementation (e.g., phenylketonuria)\n5. Inability to provide informed consent due to intellectual disability\n6. Protected populations (e.g., prisoners)\n7. Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility)\n8. Documented dementia, mild or moderate traumatic brain injury\n9. Inability to consume supplement or placebo due to head or neck trauma\n10. Low-energy fragility fracture (i.e. ground level falls)\n11. Pathologic fracture (i.e. fracture through site of compromised bone due to infection, neoplasm, documented osteoporosis, metabolic bone disease from conditions such as end stage renal disease, osteomalacia, hypophosphatemic rickets, renal osteodystrophy, osteofibrous dysplasia)","ALL","18 Years","55 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC) after lower extremity fracture fixation. Investigators hypothesize that perioperative oral supplementation with an investigational CEAA supplement (ICS) will reduce postoperative fracture-related infections, fracture nonunion rates, and skeletal muscle wasting in patients with traumatic lower extremity fractures. This is supported by strong pilot data. Conducting a randomized controlled trial at five civilian tertiary referral centers and one military treatment facility will further study the potential benefits of oral CEAA supplementation for preventing the stated key postoperative complications in patients following high energy lower extremity orthopedic trauma. This low cost, low risk intervention has demonstrated potential to expedite Warfighter return to duty as well as potentially reducing delayed limb amputations and mortality in severely injured patients.",[26],"Lower Extremity Fracture","NOT_YET_RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-18","ACTUAL",{"date":33,"type":20},"2026-09-01",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"University of Minnesota","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"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",{"count":48,"type":20},250,[23],"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.",[52,53,54,55,56,57,58,26,59],"Infections","Infected Wound","Nonunion of Fracture","Injury Leg","Amputation","Internal Fixation; Complications, Infection or Inflammation","Fracture","Antibiotic Side Effect","RECRUITING","2026-06-09",{"date":63,"type":31},"2026-06-11",{"date":65,"type":31},"2023-05-30",{"date":67,"type":20},"2028-09-29",{"name":69,"class":38},"Major Extremity Trauma Research Consortium",13,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100468594","pre-operative-inspiratory-muscle-strength-training-in-total-joint-surgery-100468594","NCT05381818","Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery","Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery","Inclusion Criteria:\n\n* 18 or older\n* History of current or previous tobacco use (including vaping containing nicotine products)\n* One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex.\n* History of smoking related lung disease\n* Projected surgical time \\> 30 minutes\n* Ability to follow instructions to complete IMT exercises\n* Ability to communicate adverse effects such as pain or fatigue or the need for assistance\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists physical status classification of 4 or greater .\n* Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication,\n* Preoperative dependence on continuous supplemental oxygen dependence.\n* Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted),\n* Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke),\n* Participating in a pulmonary rehabilitation program\n* Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1\\\u003C50% predicted.\n* Patients with an infectious disease requiring isolation (i.e. COVID-19).","100 Years",{"count":80,"type":20},36,[82],"NA","The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.",[85,86,26,87],"Arthropathy of Knee","Arthropathy of Hip","Orthopedic Disorder",[89,90,91],"Inspiratory muscle training","Pulmonary complications","Total joint replacement","2026-05-13",{"date":94,"type":31},"2026-05-15",{"date":96,"type":31},"2022-07-01",{"date":98,"type":20},"2026-12",{"name":100,"class":38},"University of Florida",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":15,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":101},"100609672","phase-4-pre-incision-peripheral-nerve-blocks-for-lower-extremity-fracture-surgery-in-older-adults-100609672","NCT07217626","Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults","Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study","Inclusion Criteria:\n\n1. Age ≥50 years\n2. Isolated fractures\n3. Radiographically confirmed lower extremity fracture requiring surgical fixation including:\n\n   1. Femoral shaft\n   2. Distal femur\n   3. Patella\n   4. Proximal tibia\n   5. Tibial shaft\n   6. Distal Tibia\n   7. Pilon fractures\n   8. Ankle (malleolar fractures)\n   9. Calcaneus\n   10. Talus\n   11. Hindfoot\u002Fmidfoot\n4. Acute fracture receiving definitive fixation during injury hospitalization\n\n4\\) Ability to provide informed consent (patient or legally authorized representative (LAR))\n\nExclusion Criteria:\n\n1. Contraindication to peripheral nerve block\n\n   1. Infection at planned needle insertion site\n   2. Patient refusal\n   3. Surgeon or anesthesiologist refusal secondary to the patient's medical status\n2. Active peripheral nerve blockade from initial injury analgesic management is defined as:\n\n   a. Risk of local anesthetic systemic toxicity\n3. Neurologic or vascular injuries in the affected limb\n4. Polytrauma with traumatic brain injury\n5. Thoracic injury and\u002For abdominal injury requiring surgical intervention\n6. Current enrollment in a conflicting clinical trial\n7. Acute or Subacute residence prior to injury\n8. Incarcerated at the time of enrollment\n9. Prior enrollment in this trial\n10. Unable to obtain informed consent due to language barrier\n11. Unable to obtain informed consent because a legally authorized representative was unavailable.\n12. Anticipated problems with follow-up compliance","50 Years",{"count":111,"type":20},34,[113],"PHASE4","Fractures of the lower leg are especially difficult for older adults. They are more likely to have serious complications, require longer healing times, and have a higher risk of death This occurs because their bodies cannot tolerate stress as well as younger individuals. The injury itself places significant strain on the body, and surgery adds additional stress.\n\nAnesthesiologists use nerve blocks to help manage pain during and after these injuries. A nerve block is an injection that numbs the fracture and surgery area by blocking pain signals. These injections help patients need fewer opioid medications. However, new research shows these nerve blocks may provide benefits beyond pain management. Studies looking at older adults with hip fractures who received nerve blocks showed better overall outcomes: fewer deaths, fewer serious complications, and shorter hospital stays.\n\nHowever, it is not currently known if nerve blocks work this well for other broken bones in the leg, like in the thigh or shin. Additional research is need to know if nerve blocks can help patients with all types of leg fractures recover faster and experience fewer problems.\n\nBefore the investigators start a large clinical trial, a small pilot study needs to be completed to determine if a larger clinical trial is feasible. This pilot study will evaluate the ability to recruit enough patients, ensure patients can receive the assigned treatment, collect data effectively, follow the study protocol, and track participants over time. The results will indicate whether the investigators are prepared to proceed with a full-scale trial and help refine the approach.",[26,116,117,118],"Surgical Fracture Repair","Orthopaedic Trauma","Orthogeriatric Fractures",[120,121,122,123,124,125,118,126],"Regional Anesthesia","Clinical Outcomes","Orthopaedic trauma","Perioperative Outcomes","Pilot Study","Lower Extremity Fractures","Peripheral Nerve Blocks","2026-03-25",{"date":129,"type":31},"2026-03-30",{"date":131,"type":31},"2026-02-24",{"date":133,"type":20},"2026-12-31",{"name":135,"class":38},"University of Maryland, Baltimore",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":157,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100617117","procedural-sedation-and-analgesia-for-treatment-of-adults-with-fractures-and-dislocations-in-the-emergency-department-100617117","NCT07314450","Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department","PAINEX","Inclusion Criteria:\n\n1. Age ≥18.\n2. Patients with the following injuries are eligible:\n\n   1. Reduction treatment of shoulder dislocation\n   2. Reduction treatment of elbow dislocation\n   3. Reduction treatment of distal radius fractures, application of cast\n   4. Reduction treatment of finger fractures\u002Fdislocation\n   5. Casting treatment of upper extremity fractures\n\n      * Proximal humerus fracture, application of fixed sling\n      * Humeral shaft fracture, application of Sarmiento brace\n      * Supracondylar fracture, application of angled cast\n   6. Reduction treatment of hip dislocation\n   7. Reduction treatment of patella dislocation\n   8. Reduction of tibial shaft fracture, application of cast\n   9. Reduction treatment of ankle fractures including distal tibia fracture\n   10. Reduction treatment for toe fractures\u002Fdislocation\n   11. Casting treatment of lower extremity fractures\n\n       * Distal femur fracture, application of cast\u002Ftraction\n       * Proximal tibia fracture, application of cast or hinged brace\n       * Ankle fracture, application of walker\n\nExclusion Criteria:\n\n1. Unable to give informed consent (e.g. unconscious, psychotic or dementia)\n2. Unwilling to participate in the study\n3. Prior inclusion in the study\n4. Already included in another clinical study at the same day\u002Fhospital visit\n5. Pregnant or breastfeeding",{"count":144,"type":20},200,"OBSERVATIONAL","The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.\n\nThe main questions it aims to answer are:\n\n* Which sedation and analgesia methods provide the best patient satisfaction and pain relief?\n* How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?\n\nThe investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation\u002Fanalgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.\n\nParticipants will:\n\nBe adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.\n\nReceive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.\n\nReport their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.",[148,149,150,151,152,153,154,26,155,156],"Pain, Procedural","Analgesia","Extremity Injury","Patient Satisfaction","Satisfaction, Personal","Satisfaction","Upper Extremity Injury","Upper Extremity Fracture","Extremity Injuries Lower",[158,159],"Emergency Department","Procedural sedation and analgesia","2025-12-17",{"date":162,"type":31},"2026-01-02",{"date":164,"type":31},"2025-07-29",{"date":166,"type":20},"2026-07-01",{"name":168,"class":38},"Region Zealand",3,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":15,"minAge":16,"maxAge":78,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":101},"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,{"count":179,"type":20},40,[82],"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.",[183,26],"Tibial Fractures","2025-11-18",{"date":186,"type":31},"2025-11-21",{"date":188,"type":31},"2024-11-01",{"date":190,"type":20},"2026-05-31",{"name":192,"class":38},"Denver Health and Hospital Authority"]