[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoral-shaft-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoral-shaft-fracture":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100566684","prospective-validation-study-of-the-cd8temra-cells-as-a-prognostic-biomarker-of-healing-outcome-after-fracture-100566684",false,"NCT06658379","Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture","BioBone","Inclusion Criteria:\n\n* male or female subjects\n* subjects \\> 18 to 80 years of age at the time of screening\n* closed fractures\n* fractures of the humerus-shaft, forearm-shaft, femur and tibia\n* Subjects suffering monotrauma or comparable with monotrauma, due to comparable post-surgery mobilisation\n* osteosynthesis\n* subject has signed an informed consent form\n* legal capacity\n\nExclusion Criteria:\n\n* cancer related fractures\n* periprosthetic fractures\n* known active Hepatitis B virus or Hepatitis C virus infection at screening\n* known human immunodeficiency virus (HIV) infection, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease\n* active malignancy or history of malignancy within 5 years prior to screening\n* known diagnosis of moderate to severe dementia based on subject's medical history or severe psychiatric disorder\n* known history of drug or alcohol abuse in the past 12 months, based on self-report or medical record\n* history of autologous\u002Fallogeneic bone marrow (BM) or solid organ transplantation\n* exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening\n* pregnancy\n* subject is currently enrolled in an investigational device or drug trial, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).\n* subject is detained or institutionalized under a court order or administrative order\n* in the opinion of the investigator, the subject is unsuitable for participating in the study (patient compliance).","ALL","18 Years","80 Years",{"count":20,"type":21},640,"ESTIMATED","OBSERVATIONAL","In approx. 10-15% of all fracture patients, there is a prolonged healing time or even a complete absence of fracture healing (non-union). As a result, these patients require further surgical interventions, combined with renewed or prolonged hospitalisation\u002Frehabilitation and incapacity to work. To summarise, this therefore represents a serious socio-economic problem. At present, there is no prognostic method for the early prediction of patients at risk of a disturbed healing process. However, if these patients are successfully stratified, there are already a variety of therapeutic strategies available to additionally stimulate fracture healing. Therefore, the aim is to conduct a prospective clinical study to validate CD8+ TEMRA cells as a prognostic marker of impaired fracture healing. The investigators assume that preoperative CD8+ TEMRA cell expression represents a prognostic biomarker with high diagnostic precision for differentiating between a) normal healing patients, b) delayed healing patients and c) pseudarthrosis patients. Furthermore, the sensitivity and specificity should be high enough, health-economically significant and realisable in clinical routine.",[25,26,27,28,29,30,31,32,33,34,35,36],"Fracture Non Union","Fracture Healing","Long Bone Delayed-Union Fracture","Humerus Shaft Fracture","Forearm Fracture","Femoral Neck Fractures","Femur Distal Fracture","Pertrochanteric Fracture of Femur","Femoral Shaft Fracture","Proximal Tibia Fracture","Tibial Shaft Fracture","Distal Tibia Fracture",[38,39,40,41,42,43,44,45,46],"long bone fracture","impaired fracture healing","fracture non-union","prognosis","prognostic biomarker","Immune system","T cells","radiology","bone fracture healing","RECRUITING","2024-10-23",{"date":50,"type":51},"2024-10-26","ACTUAL",{"date":53,"type":51},"2016-12",{"date":55,"type":21},"2025-06",{"name":57,"class":58},"Charite University, Berlin, Germany","OTHER",7,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":94,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100522111","opioid-free-pain-treatment-in-trauma-patients-100522111","NCT06078371","Opioid-Free Pain Treatment in Trauma Patients","Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients","Inclusion Criteria:\n\n* Patient is over the age of 18 years old\n* Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital\n\nExclusion Criteria:\n\n* Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury\n* Chronic opioid use\n* Under the age of 18 years old\n* Undergoing revision surgery\n* Did not undergo surgical fixation\n* Pregnant\u002Fnursing women\n* Vulnerable populations as defined by the University of Kansas Medical Center IRB\n* Did not experience one of the following fractures listed in D.1. above.\n* Patients with CKD and\u002For cirrhosis will be excluded from the opioid-free pain block (block 2) and will only qualify for the standard of care opioid group (Block 1)",{"count":68,"type":21},250,"INTERVENTIONAL",[71],"NA","Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.",[30,74,33,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"Intertrochanteric Fractures","Distal Femur Fracture","Patella Fracture","Tibial Shaft Fracture with or Without Associated Fibula Fracture","Ankle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar)","Tibial Pilon Fracture","Talar Head, Neck, Body, or Process Fractures","Calcaneus Fractures","Lisfranc Injuries","Isolated or Multiple Metatarsal Fractures","Phalanx Fractures of the Foot, Single or Multiple","Clavicle Fractures","Proximal Humerus Fractures","Humeral Shaft Fractures","Distal Humerus Fractures (intra or Extra-articular)","Olecranon Fractures","Radial Head or Neck Fractures","Elbow Fractures Involving a Combination of Fractures of the Radius and Uln","Forearm Fractures (both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)","Distal Radius Fractures",[95,96],"Surgical Intervention","Trauma","2024-10-22",{"date":50,"type":51},{"date":100,"type":51},"2023-11-01",{"date":102,"type":21},"2026-10",{"name":104,"class":58},"University of Kansas Medical Center",1]