[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fracture-fixation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fracture-fixation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,75,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628176","phase-3-efficacy-of-integrating-next-generation-sequencing-for-treatment-of-surgical-site-infection-after-fracture-fixation-100628176",false,"NCT07458230","Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:","Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation: A Multicenter Randomized Control Trial","NGS","Inclusion Criteria:\n\n* Age 18-84 years\n* History of extremity fracture proximal to the metatarsals and carpal bones treated with any type of internal fixation. Note that both healed and unhealed fractures are eligible.\n* Deep infection requiring surgery after fracture fixation as determined by either of the following:\n\nFRI confirmatory criteria CDC criteria (without the timeframe). This includes the possibility of culture negative infection but determined to be infection by treatment team.\n\n* Plan for treatment includes antibiotic therapy prescribed by Infectious Disease provider(s), regardless of SOCHB culture or NGS results.\n\nExclusion Criteria:\n\n* Spine fractures\n* High risk of amputation based on the initial managing physician opinion\n* Incarcerated\u002Finstitutionalized\n* Patient is too sick to have surgery, i.e., medical co-morbidities which preclude treatment with a general anesthetic\n* Prior history of chronic infection at the surgical site\n* Pathological fractures from a neoplastic process\n* History of Paget's Disease\n* Unavailable for the planned 12 months of follow-up (e.g., planned follow-up at a location other than one of the study sites)\n* Extremity fracture occurred more than 2 years prior to the hospital admission for the presenting infection","ALL","18 Years","84 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study focuses on the serious problem of infections and wound-healing issues that can happen after high-energy bone fractures. These complications are common and can affect between 10% and 60% of patients, especially those with severe injuries. When a fracture is repaired with surgery and an infection develops afterward, patients often face long recovery times, more pain, and sometimes multiple surgeries. In the worst cases, the infection can lead to permanent disability or even amputation. The current standard test used in hospitals, called a culture, often misses certain bacteria, which can make treatment less effective. Because of this, the study aims to find out whether adding a newer test called Next Generation Sequencing (NGS) can help doctors identify infections more accurately and improve patient outcomes.\n\nThe main goal of the study is to see whether using NGS along with standard hospital cultures reduces the number of treatment failures compared to using standard cultures alone. Treatment failure means the infection does not get better and the patient must return to the operating room. The study also wants to learn whether NGS helps doctors make better antibiotic choices and avoid unnecessary or ineffective treatments. Another goal is to understand which NGS results are most helpful when doctors decide to change a patient's antibiotics. By learning this, researchers hope to create a model that explains how NGS information influences treatment decisions.\n\nTo join the study, patients must be between 18 and 84 years old and have a deep infection after a fracture was repaired with internal fixation, such as plates, screws, or rods. Patients must also meet infection criteria from either the Fracture-Related Infection (FRI) guidelines or the CDC's infection criteria. A total of 250 patients will be randomly placed into one of two groups: one group will receive treatment guided by both NGS and standard cultures, while the other group will receive treatment based only on standard cultures. Researchers will then compare how often treatment fails in each group.\n\nTreatment failure includes several possible outcomes. The most important is an unplanned return to the operating room because the infection did not improve. Other types of failure include new superficial infections that do not require surgery, bones that fail to heal properly (called nonunion), amputation, and complications caused by antibiotics. Patients will return for follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after joining the study so researchers can track the patient's progress and monitor for any problems.\n\nRight now, the failure rate for treating these infections using standard hospital cultures is about 30%, which is considered unacceptably high. The researchers believe that adding NGS will help lower this number because NGS can detect more types of bacteria, including ones that are hard to grow in a lab. With better information, doctors can choose antibiotics that are more likely to work the first time, which may reduce the need for additional surgeries and improve healing. This could be especially important for military service members, who often suffer high-energy injuries and face a greater risk of long-term complications if treatment fails.\n\nNGS is already available, covered by Medicare, and fast enough to be useful in real-time medical decisions. If this study shows that NGS improves treatment outcomes, hospitals could begin using it widely and quickly. The researchers hope that this approach will lead to fewer infections, better antibiotic use, faster recovery, and improved long-term function for patients.",[28,29,30],"Next Generation Sequencing (NGS)","Surgical Site Infection (SSI)","Fracture Fixation",[28],"NOT_YET_RECRUITING","2026-05-07",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":22},"2026-07-01",{"date":40,"type":22},"2028-10-01",{"name":42,"class":43},"Johns Hopkins Bloomberg School of Public Health","OTHER",18,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100635444","phase-4-a-clinical-trial-on-the-use-of-lidocaine-infusion-during-surgery-for-pediatric-upper-extremity-fractures-and-its-impact-on-total-perioperative-opioid-requirements-100635444","NCT07552766","A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements","A Prospective, Randomized, Double-blind Trial of the Impact of Intraoperative Intravenous Lidocaine Infusion on Total Opioid Requirements in Children Undergoing Surgical Fixation of Upper Extremity Long Bone Fractures Under General Anesthesia","Inclusion Criteria:\n\n* Patients aged 3-18 years\n* Patients \\> 10 kg\n* Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius\n\nExclusion Criteria:\n\n* Children \\\u003C 3 years or \\> 18 years\n* Patients with allergy to local anesthetics\n* Patients who are eligible for an receive a peripheral nerve block\n* Patients with multi-trauma or open fractures\n* Patients with previous history of seizure disorder\n* Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment\n* Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)\n* Patients with chronic kidney or liver dysfunction\n* Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)\n* Patients with positive pregnancy test prior to surgery or nursing mothers\n* Patients who parents decline enrollment","3 Years",{"count":54,"type":22},90,[56],"PHASE4","This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery.\n\nAll participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes.\n\nPatients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.",[59,60,61,30,62,63,64],"Fracture Arm","Fracture Closed of Lower End of Forearm, Unspecified","Fracture Elbow","Fracture Fixation, Internal","Fracture Forearm","Fracture Distal Radius","2026-04-22",{"date":67,"type":36},"2026-04-27",{"date":69,"type":22},"2026-05",{"date":71,"type":22},"2029-07",{"name":73,"class":43},"Nemours Children's Clinic",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":74},"100610962","animated-video-and-associated-pain-and-anxiety-reduction-following-pin-removal-post-supracondylar-fracture-fixation-100610962","NCT07234396","Animated Video and Associated Pain and Anxiety Reduction, Following Pin Removal Post-supracondylar Fracture Fixation","Animated Procedure Video Reduces Pain and Anxiety Among Pediatric Patients Undergoing Pin Removal Following Supracondylar Fracture Fixation - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with supracondylar fractures operated on for percutaneous K-wire fixation.\n* Age between 4 to 12 years\n\nExclusion Criteria:\n\n* Any syndromic patients\n* Patients having any visual or cognitive disability\n* Patients having any pre-operative or post-operative complications before pin removal.\n* Patients undergoing the procedure under general anesthesia.\n* Age \\\u003C4 or \\>12","4 Years","12 Years",{"count":85,"type":22},120,[87],"NA","Assessing the reduction in pain and anxiety by the use of showing an animated video of the procedure, among pediatric patients undergoing pin removal after fixation of supracondylar fractures.",[90,30,91,92],"Supracondylar Fractures","Pain Severity","Anxiety","RECRUITING","2025-11-19",{"date":96,"type":36},"2025-11-24",{"date":98,"type":36},"2025-10-31",{"date":100,"type":22},"2026-01-20",{"name":102,"class":43},"Liaquat National Hospital & Medical College",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":74},"100558694","post-surgical-multimodal-analgesia-with-oral-strong-opioids-100558694","NCT06554457","Post Surgical Multimodal Analgesia With Oral Strong Opioids","Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia","ORORA","Inclusion Criteria:\n\n1. Aged 18 or older\n2. Must undergo one of the following treatments:\n\n(1) Fracture of upper or lower limbs or pelvis requiring internal fixation surgery (2) Spinal fusion surgery (3) Joint replacement surgery 3. Requiring multimodal analgesics for postoperative pain control, with oral strong opioids as the primary opioid analgesic, as assessed by his\u002Fher physician.\n\n4\\. Voluntarily sign the informed consent form and agree to the collection of clinical questionnaires and medical-related information for this study.\n\nExclusion Criteria:\n\n1. Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).\n2. Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.\n3. Patients who use patient-controlled analgesics for pain control after surgery.\n4. Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).\n5. Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.\n6. Other cases deemed ineligible by the study investigator.",{"count":112,"type":22},200,"OBSERVATIONAL","This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.",[116,117,30],"Orthopedic Procedures","Arthroplasty","2024-08-14",{"date":120,"type":36},"2024-08-15",{"date":122,"type":22},"2024-08-12",{"date":124,"type":22},"2025-07-31",{"name":126,"class":43},"Tri-Service General Hospital"]