[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,45,78,106,132,161,195,221,245,268,295,324,351,373],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100626031","phase-1-buprenorphine-for-analgesia-in-older-adults-with-acute-fractures-in-the-emergency-department-100626031",false,"NCT07430345","Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department","Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study","Inclusion Criteria:\n\n* Age 65 years or older\n* Emergency Department patient\n* Diagnosis of suspected or confirmed acute fracture\n* Numerical Rating Scale 4 or greater at time of presentation\n* Must be able to give informed consent or have a surrogate decisionmaker to provide informed consent\n* Subjects who may require a surgical procedure are eligible for enrollment, as given the low dose of buprenorphine, this is not anticipated to affect future anesthesia. If additional pain control is needed for surgical procedure, full agonist opioid can be used without contraindication.\n\nExclusion Criteria:\n\n* Prior history of opioid use disorder\n* Participants taking chronic opioid therapy (defined as opioids taken during the past month)\n* Allergy to study medications\n* Hemodynamic instability requiring immediate resuscitation\n* Inability to consent and absence of surrogate decisionmaker","ALL","65 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to learn if buprenorphine can treat pain in older adults who have broken bones. The main questions it aims to answer are:\n\nIs buprenorphine as effective as opioids to treat pain? Are there less side effects with buprenorphine? Researchers will compare buprenorphine and hydromorphone to see if there are differences in pain control and side effects.\n\nParticipants will be given one of the two study drugs after breaking a bone and asked about their pain scores and side effects for the next 48 hours.",[27],"Fracture",[29,30,31],"buprenorphine","geriatric","analgesia","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2026-05-07",{"date":40,"type":20},"2027-01",{"name":42,"class":43},"The Cooper Health System","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"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":55,"type":20},250,[57],"PHASE3","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.",[60,61,62,63,64,65,27,66,67],"Infections","Infected Wound","Nonunion of Fracture","Injury Leg","Amputation","Internal Fixation; Complications, Infection or Inflammation","Lower Extremity Fracture","Antibiotic Side Effect","2026-06-09",{"date":70,"type":36},"2026-06-11",{"date":72,"type":36},"2023-05-30",{"date":74,"type":20},"2028-09-29",{"name":76,"class":43},"Major Extremity Trauma Research Consortium",13,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100625373","clinical-validation-of-rbfracture-for-diagnosing-trauma-related-musculoskeletal-injuries-100625373","NCT07421791","Clinical Validation of RBfracture for Diagnosing Trauma-related Musculoskeletal Injuries","Clinical Validation of RBfracture to Demonstrate Improved Diagnostic Performance of the Intended Users","Inclusion Criteria:\n\n* XR exams of a patient ≥22 years of age following a recent acute musculoskeletal trauma.\n* Modality is digitally acquired radiographs (Computed Radiography or Digital Radiography)\n\nExclusion Criteria:\n\n* XR exam types that are outside of the intended use (e.g., chest, abdomen, facial bones, cervical spine).\n* Exams with missing patient age.\n* Exams from follow-up patient examinations, e.g., post-surgical controls or evaluation of fracture healing.\n* Any exams containing radiographs previously used in software development.\n* Exams containing additional radiographs that are incoherent with the XR exam type (e.g., wrist radiograph in a hip and pelvis exam type).\n* Radiograph views that are unsupported.\n* Poor radiographic image quality, rendering radiograph clinically unsuitable (e.g., inappropriate selection of technical exposure factors, patient motion, presence of artefacts, and improper collimation of the radiographic beam).",true,"22 Years",{"count":88,"type":20},415,"OBSERVATIONAL","The goal of this study is to determine if the computer software, RBfracture, developed by Radiobotics, helps primary care, emergency, and radiology clinicians more easily identify bone injuries caused by a traumatic impact (such as a fall or car collision). RBfracture uses artificial intelligence (AI) to analyze X-ray images of patients to identify fractures and joint dislocations visible on the X-ray images. RBfracture also identifies fluid buildup in the elbow and knee joints resulting from a fracture or dislocation.\n\nSixteen clinicians will review X-ray images from 415 adult patients, who may have sustained a bone injury, to diagnose any injuries visible on their X-ray images. First, the clinicians will review half of the images with and half of the images without the help of the RBfracture software. After a 4-week break, the clinicians will once again review the same images. This time, the software's help will be switched, so it is unavailable for the images the clinicians previously reviewed with it, and available for the images they reviewed without it.\n\nThe number of correct and incorrect diagnoses made by the clinicians when they were helped by the software will be compared to the number of correct and incorrect diagnoses made by the clinicians when they did not receive any help from the software. This comparison will reveal if using the software helps clinicians to diagnose more injuries and miss less injuries.",[27,92,93,94],"Joint Dislocation","Joint Effusion","Knee Lipohemarthrosis","NOT_YET_RECRUITING","2026-02-24",{"date":98,"type":36},"2026-02-27",{"date":100,"type":20},"2026-02",{"date":102,"type":20},"2026-04",{"name":104,"class":105},"Radiobotics","INDUSTRY",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100257804","fragility-fracture-liaison-service-and-anti-osteoporosis-medication-monitoring-service-study-100257804","NCT02635022","Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study","Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study in Rural Area","Inclusion Criteria:\n\n* Age \\>=50 and one of the below\n* New hip fracture in orthopedic ward\n* Newly identified radiographic vertebral fractures from plan films in geriatric ward or clinical vertebral fractures in outpatient clinics\n* Newly prescribed with AOMs\n* Recent change of AOMs\n* Poor adherence to AOMs\n* Participating physicians feel that the service will benefit the patient in overall osteoporosis and medication managements.\n\nExclusion Criteria:\n\n* Life expectancy less than 2 years or can't be assessed for communication problems\n* Atypical fractures\n* Patient in other medication clinical trials\n* Unwilling to accept the assessment and treatment","50 Years",{"count":115,"type":20},200,"Aims: (1) to Establish the FLS services at the National Taiwan University Hospital Jinshan Branch. (2) To establish a anti-osteoporosis medication management service at Jinshan Branch.\n\nMethod: From Aug., 2015, a fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital Jinshan Branch health care system. The Jinshan Branch program enrolled patient with 1) new hip fracture 2) newly identified vertebral fractures (radiological or clinical) from both inpatients and outpatients. At the same time, a osteoporosis medication management service is also establish as a complement of FLS to enroll patients on antiosteoporosis medications (AOMs) but not necessary with fracture.\n\nParticipating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis\u002Ffracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases.\n\nDuring the whole study period, the investigators planed to enroll 200 patients (with or without fracture). Each patient would be assessed at baseline, and every 4 months last for two years.",[118,27],"Osteoporosis",[27,120,118,121,122],"Sarcopenia","Care management","Medication adherence","2025-12-16",{"date":125,"type":36},"2025-12-23",{"date":127,"type":36},"2015-09",{"date":129,"type":20},"2026-12",{"name":131,"class":43},"National Taiwan University Hospital",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":139,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100485642","exactech-shoulder-post-market-clinical-follow-up-study-100485642","NCT05603728","Exactech Shoulder Post Market Clinical Follow-up Study","An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes","Inclusion Criteria:\n\n* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)\n* Patient is skeletelly mature\n* Patient is expected to survive at least 2 years beyond surgery\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Medial humeral bone loss resulting in compromised humeral stem fixation\n* Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation\n* Neuromuscular disorders that do not allow control of the joint\n* Significant injury to the brachial plexus\n* Non-functional deltoid muscles\n* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient is contraindicated for the surgery\n* Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)\n* Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)\n* Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)\n* Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)","21 Years",{"count":141,"type":20},20000,"The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.",[144,145,146,147,148,149,150,27,60],"Osteo Arthritis Shoulders","Osteonecrosis","Rotator Cuff Tears","Rotator Cuff Tear Arthropathy","Ankylosing Spondylitis","Post-traumatic Osteoarthritis","Rheumatoid Arthritis","2025-12-09",{"date":153,"type":36},"2025-12-15",{"date":155,"type":36},"2007-07-19",{"date":157,"type":20},"2031-12-31",{"name":159,"class":105},"Exactech",38,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":85,"sex":16,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":173,"studyType":89,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":44},"100467071","pediatric-orthopaedic-implant-safety--efficacy-100467071","NCT05361980","Pediatric Orthopaedic Implant Safety & Efficacy","Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program","Global POISE","Inclusion Criteria:\n\n* Patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. Off-label use is strongly discouraged; however, any and all on- and off-label indications for use of the products in this program will be collected and stratified accordingly\n* Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product\n* Informed consent\u002Fassent is required\n\nExclusion Criteria:\n\n* Patients with a demonstrated sensitivity to metals\n* Patients with an inability to follow a post-operative regimen","0 Years","25 Years",{"count":172,"type":20},4000,"2 Years","Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity.\n\nGiven the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy.\n\nProspective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).",[27,176,177,178,179,180,181,182,183,184,185],"Lengthening; Leg","Orthopedic Disorder","Deformity of Limb","Deformity; Bone","Implant Breakage","Implant Complication","Hip Dysplasia","Pediatric ALL","Hip Disease","Hip Dislocation","2025-11-19",{"date":188,"type":36},"2025-11-24",{"date":190,"type":36},"2022-01-06",{"date":192,"type":20},"2029-12",{"name":194,"class":43},"University of British Columbia",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":44},"100609933","phase-4-single-shot-exparel-vs-catheters-in-lower-extremity-trauma-100609933","NCT07221019","Single Shot Exparel vs Catheters in Lower Extremity Trauma","Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients","Inclusion Criteria:\n\n* Closed lower extremity orthopedic injury\n* Opioid naive patients\n* No other significant surgical injuries on admission as determined by study physician\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Multiple traumatic injuries\n* Weight less than 60 kg\n* Prior opioid use or risk of increased pain control needs as determined by PI\n* Chronic opioid use\n* Open fractures\n* Plastic surgery needed for complete closure\n* Patient has intraoperative cardiac arrest",{"count":203,"type":20},90,[205],"PHASE4","This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.",[208,209,210,211,27],"Fracture Dislocation of Ankle Joint","Fracture Leg","Fracture Femur","Fracture Lower Leg","2025-10-24",{"date":214,"type":36},"2025-10-28",{"date":216,"type":36},"2025-09-12",{"date":218,"type":20},"2029-08-11",{"name":220,"class":43},"George Washington University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":44},"100510452","clinical-and-radiological-outcomes-of-medacta-shoulder-system-fr-100510452","NCT05926622","Clinical and Radiological Outcomes of Medacta Shoulder System FR","Clinical and Radiological Outcomes of Medacta Shoulder System","Inclusion Criteria:\n\n* Patients older than 18 years\n* Patient with one of the following diagnosis:\n\nPrimary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (\\\u003C21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty\n\nExclusion Criteria:\n\n* Patients with malignant diseases (at the time of surgery)\n* Patients with proven or suspect infections (at the time of surgery)\n* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)\n* Patients with known incompatibility or allergy to products materials (at the time of surgery)",{"count":115,"type":20},"This is a post-marketing surveillance on Medacta Shoulder System",[231,232,147,233,234,27,235],"Primary Osteoarthritis","Secondary Osteoarthritis","Rheumatoid Arthritis Shoulder","Avascular Necrosis","Revision of Shoulder Arthroplasty","2025-09-23",{"date":238,"type":36},"2025-09-29",{"date":240,"type":36},"2022-03-15",{"date":242,"type":20},"2037-03",{"name":244,"class":105},"Medacta International SA",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100433264","case-series-on-the-clinical-performance-of-va-clavicle-and-clavicle-hook-plate-27-systems-100433264","NCT04921865","Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems","Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Unilateral clavicel injury and primary surgical treatment within 21 days from injury with a DPS VA-LCP® Clavicle Plate according to manufacturer's instruction use:\n\n  * VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments\n  * VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint\n  * VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations\n* Expected ability to attend postoperative FU visits\n* Patient informed and consent obtained according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Stable clavicle fractures\n* Systemic infection or infection localized to the site of the proposed implantation\n* Concomitant nerve or vessel injury\n* Polytrauma (Injury Severity Score ≥ 16)\n* BMI ≥40\n* Uncontrolled severe systemic disease or terminal illness\n* Intraoperative decision to use other implant",{"count":253,"type":20},76,"The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System.\n\nA minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation.\n\nOutcomes will be collected until up to 2 years after surgery.",[256,257,27],"Clavicle","Acromioclavicular Joint","2025-08-28",{"date":260,"type":36},"2025-08-29",{"date":262,"type":36},"2024-07-10",{"date":264,"type":20},"2029-09-30",{"name":266,"class":43},"AO Innovation Translation Center",7,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":44},"100461695","phase-4-single-dose-intravenous-iron-therapy-for-anemia-after-orthopaedic-trauma-100461695","NCT05292001","Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma","Role of Single-dose Intravenous Iron Therapy for the Treatment of Anemia in the Setting of Orthopaedic Trauma: a Pilot Study","Inclusion criteria:\n\n1. Patients age 18-89 admitted with a lower extremity or pelvis fracture requiring surgical stabilization\n2. Acute blood loss anemia as defined by hemoglobin concentration between 7.0-11.0g\u002FdL within seven days post-operatively from definitive fracture stabilization during the hospital admission\n\nExclusion criteria:\n\n1. History of intolerance or hypersensitivity to IV iron supplementation\n2. Active hemorrhage requiring greater than two units (whole blood or pRBCs) transfused perioperatively\n3. 1\\. Multiple planned operative procedures during the trauma admission, excluding orthopaedic staged procedures for the fracture meeting inclusion criterion one (such as temporizing external fixator application and washout for open fracture) in which subjects otherwise meet qualifications for enrollment after definitive stabilization\n4. Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease)\n5. Diagnosis of chronic kidney disease and\u002For chronic liver disease\n6. Known infection, inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, and ankylosing spondylitis), or malignancy\n7. Pregnancy\n8. Iron overload (defined as serum ferritin concentration ≥ 1,000ng\u002FmL, serum iron concentration \\> 160μg\u002F dL, or serum transferrin saturation ≥ 50%) or any condition associated with iron overload (e.g., hemochromatosis and aceruloplasminemia)\n9. Patients that are tenets of the Jehovah's Witness faith\n10. Vulnerable populations including pediatric patients, geriatric populations 90 or older, incarcerated individuals, those unable to provide informed consent\n11. Inability to refrain from oral iron supplementation during study period\n12. Current or recent (within 30 days) use of immunosuppressive agents\n13. Use of any intravenous iron therapy or recombinant human erythropoietin formulation within the previous 30 days","89 Years",{"count":277,"type":20},150,[205],"Acute blood loss in orthopaedic trauma and operative fracture care contributes substantially to perioperative anemia, which places participants at increased risk for complications including surgical site infection, cardiovascular complications, and even death. Anemia has further clinical implications in quality of life measures and is associated with fatigue, impaired physical performance, decreased exercise capacity, and mood disturbances. Thus, evaluation and treatment of perioperative anemia is critical in risk mitigation within orthopaedic surgery. The current standard of care for anemia is transfusion of packed red blood cells in only cases of severe anemia due to the substantial associated risks. A safer alternative is desirable because a critical number of participants do not meet the restrictive transfusion threshold and may suffer negative effects from anemia during recovery from the acute insult. The focus of this project is to pilot an investigation of the benefits of intravenous iron therapy (IVIT) in traumatically injured patients. Specifically, Aim I will determine feasibility of study design, recruitment, randomization, intervention implementation, blinded procedures, and retention. In Aim II, time to return to normal hemoglobin following traumatic orthopaedic injury will be assessed. With Aim III, the investigators will measure IVIT effect on participant-reported fatigue, physical function, and depression, and further determine if resolution of anemia is correlated to improvements in these measures in traumatically injured orthopaedic patients. Aim IV will focus on evaluating the role of IVIT on immune cells through a variety of novel laboratory assessments. The investigators expect this study to provide a better understanding of IVIT, which has the potential to alter providers' treatment approach of anemia in participants who sustain traumatic orthopaedic injury, thereby leading to decreased risks and improved recovery.",[281,27],"Acute Blood Loss Anemia",[283,284,285],"intravenous iron therapy","anemia","orthopaedic trauma","2025-08-04",{"date":288,"type":36},"2025-08-08",{"date":290,"type":36},"2022-06-01",{"date":292,"type":20},"2026-05-31",{"name":294,"class":43},"Oregon Health and Science University",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":44},"100550580","phase-2-cannabidiol-after-multi-trauma-for-pain-and-opioid-therapy-100550580","NCT06448923","Cannabidiol After Multi-Trauma for Pain and Opioid Therapy","Effects of an Acute 1-month Cannabidiol Treatment on Pain and Inflammation After a Long Bone Fracture: a Triple-blind Randomized, Placebo Controlled Clinical Trial","CAM-POT","Inclusion Criteria:\n\n* Patients with a long bone fracture of the lower limb (tibia, fibula, femur, metatarsals, and phalanges) or the upper limb (humerus, radius, ulna, metacarpals, and phalanges) treated to Sacre-Coeur Hospital in Montreal (HSCM) within one week of the accident\n* Participants is between 18 and 70 years of age\n* Patients with or without surgical procedures\n\nExclusion Criteria:\n\n* Moderate\u002Fsevere traumatic brain injury (TBI)\n* Diagnosis of any of the following mental disorders as defined by the DSM-5: schizophrenia, intellectual disability, bipolar disorder, major depression, a diagnosed and untreated sleep disorders\n* History of alcohol or opioid misuse\u002Fabuse, as defined by the DSM-5\n* Evidence of severe renal (stage 4 or 5) or hepatic impairment (Child B or C)\n* Pregnant or lactating women, women of childbearing potential who are not using medically accepted forms of contraception (e.g., condoms, oral contraceptive or intrauterine device), or women who are actively planning on becoming pregnant\n* History of adverse reactions to cannabis\n* Patients taking warfarin, sildenafil, valproate or under opioids treatment prior to the injury\n* Patients experiencing on average mild-to-absent pain in the last 24h preceding recruitment (as per a score \\\u003C30 on a 0-100mm Visual Analogue Scale (VAS))\n* Transport business drivers and heavy machinery operators\n* A diagnosis of chronic pain, bone pathology (e.g., osteoporosis) or chronic inflammatory disease (e.g., rheumatoid arthritis, arthritis, psoriasis)\n* Not having French or English as a spoken language\n* A weighted MoCA score of less than 24\n* Regular cannabis use more than 5 times a week","70 Years",{"count":305,"type":20},225,[24],"The aim of this project is to investigate the therapeutic potential and safety of acute Cannabidiol (CBD) treatment on longitudinal pain symptoms, and to assess potential interactions with pain mediators including opioids and sex on CBD treatment response. To this end, this research protocol proposes a comprehensive translational approach including a placebo-controlled randomized clinical trial comparing two daily doses of CBD treatment administered for one month on pain relief. This study will also compare intervention conditions on inflammation markers, participant quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function.",[27],[310,311,312,313,27,314],"Cannabidiol","Trauma","Pain","Inflammation","Orthopaedic","2025-07-28",{"date":317,"type":36},"2025-07-30",{"date":319,"type":36},"2025-06-01",{"date":321,"type":20},"2027-06",{"name":323,"class":43},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal",{"id":325,"slug":4,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":85,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":44},"100435247","NCT04947722","The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care","PREVENT","Inclusion Criteria:\n\n* Both profit and non-profit long-term care homes in Ontario, Canada.\n* Homes must have a minimum of 50 occupied beds to participate; there is no maximum home size for participation.\n* For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.\n\nExclusion Criteria:\n\n* Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).",{"count":331,"type":20},3060,[333],"NA","Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool (\"fracture risk calculator\") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.",[27,336,118],"Fractures, Hip",[338,339,340,341],"Long-Term Care","Fracture Risk","Falls","Knowledge Translation","2025-06-27",{"date":344,"type":36},"2025-07-01",{"date":346,"type":36},"2024-06-19",{"date":348,"type":20},"2027-03-31",{"name":350,"class":43},"McMaster University",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100590192","immediate-fracture-risk-after-antihypertensive-drug-initiation-100590192","NCT06964217","Immediate Fracture Risk After Antihypertensive Drug Initiation","Overall Fracture Risk Immediately After Anti-hypertensive Medication Initiation and Temporal Trend in Initial Pharmacotherapy Regimens: An Observational Study","FADI","Inclusion Criteria:\n\n* Individuals with at least 365 days of continuous observation prior to the index date (defined as the date of first antihypertensive medication prescription), with no prior antihypertensive use during that period\n* At least one diagnosis of hypertension (ICD-10 codes I10-I13, I15) recorded within 180 days before the index date\n\nExclusion Criteria (main cohort):\n\n* Any of the following occurring in the 365 days prior to the index date: Hospitalization (inpatient admission, including long-term care facility), transport-related trauma (ICD-10 codes V01-V99), Intentional self-harm (ICD-10 codes X60-X84, Y87), History of pathological fractures (e.g., M84.4, M90.7), Evidence of end-stage renal disease (ESRD), dialysis, kidney transplant, renal osteodystrophy","100 Years",{"count":361,"type":20},10000000,"This retrospective observational study aims to evaluate the short-term fracture risk associated with anti-hypertensive medication initiation using a self-controlled case series (SCCS) design and investigate temporal trends of initial anti-hypertensive regimen (monotherapy vs combination therapy) and subsequent fracture incidence. The investigators use the Korean Health Insurance Review and Assessment (HIRA) database to identify adults aged ≥65 with a new prescription for anti-hypertensive therapy and at least one incident non-traumatic fracture.\n\nIn the SCCS analysis, the investigators estimate the within-person incidence rate of overall fractures during the 30-day period following anti-hypertensive initiation compared to control periods. Temporal trends will be recorded through 2013 - 2022.\n\nThe primary outcome is overall non-traumatic fracture occurrence; the secondary outcome is incident proximal hip fracture. These outcomes are defined using diagnostic and procedural codes validated for use in claims data. This study aims to quantify both the immediate temporal association between treatment initiation and fracture risk, and the comparative safety of different initial anti-hypertensive regimens.",[364,27],"Hypertension","2025-05-22",{"date":367,"type":36},"2025-05-28",{"date":319,"type":20},{"date":370,"type":20},"2025-07-31",{"name":372,"class":43},"Ajou University School of Medicine",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":173,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":21,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":396},"100377494","phase-2-intranasal-dexmedetomidine-plus-ketamine-for-procedural-sedation-100377494","NCT04195256","Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation","Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial","Ketodex","INCLUSION CRITERIA\n\nGeneral Criteria\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Deemed by treating physician to require procedural sedation\n\nSpecific criteria\n\n1. Children presenting to the paediatric EDs of participating sites age 2-17 years\n2. Weighing up to and including 100 kg\n3. One of the following injuries:\n\n   * Closed forearm fracture\n   * Metacarpal or phalangeal fracture\n   * Dislocation of a shoulder or elbow\n   * Type II supracondylar fracture\n4. Expected to not require more than one dose of IV sedative medication if they were not in the trial (as determined by the procedure physician and not including cast or splint application).\n5. Both nares are fully patent\n6. Physician plans to sedate patient\n\nEXCLUSION CRITERIA\n\n1. Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;\n2. Suspected globe rupture;\n3. Concomitant traumatic brain injury with intracranial hemorrhage;\n4. Uncontrolled hypertension;\n5. Nasal bone deformity or septal deviation;\n6. Poor English or French fluency in the absence of native language interpreter;\n7. American Society of Anesthesiologists (ASA) class 3 or greater;\n8. Previous diagnosis of schizophrenia or active psychosis as per the treating physician\n9. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction;\n10. More than one fracture or dislocation requiring reduction;\n11. Hemodynamic compromise as per the treating physician;\n12. Glasgow coma score \\\u003C 15;\n13. Previous sedation with ketamine or hematoma block within 24 hours;\n14. Fracture is comminuted or associated with a dislocation;\n15. Participant has undergone a hematoma block within 24 hours;\n16. Obstructive sleep apnea\n17. Previous enrollment in the trial;\n18. Suspected pregnancy\n19. Congenital heart disease or known cardiac dysrhythmia\n20. Known or suspected hepatic impairment\n21. Known renal insufficiency\n22. Uncorrected mineralocorticoid deficiency","17 Years",{"count":383,"type":20},400,[24,57],"Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).",[27,387],"Dislocation","2024-11-01",{"date":390,"type":36},"2024-11-05",{"date":392,"type":36},"2020-03-11",{"date":129,"type":20},{"name":395,"class":43},"Naveen Poonai",6]