[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07674043":3,"trial-entities:NCT07674043":95,"trial-summary:NCT07674043":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":63,"locations":66,"central_contacts":81,"overall_officials":87,"references":90,"see_also_links":91},"NCT07674043","P00054215","MY01 Pressure Monitoring in Adolescent Tibia Fractures","Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures","NOT_YET_RECRUITING","2028-06-01","2026-06","2026-06-29","2026-06-01","Boston Children's Hospital","OTHER",false,"The goal of this clinical trial is to learn more about anterior leg compartment pressures in adolescents who have sustained tibia fractures. It will also examine whether measuring anterior compartment pressure helps physicians diagnose acute compartment syndrome (ACS), a rare but dangerous complication that can develop following surgical treatment of a tibia fracture.\n\nThe main questions it aims to answer are:\n\n1. Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?\n2. Does compartment pressure monitoring aid physicians in accurately diagnosing ACS?\n\nParticipants will have a continuous pressure monitoring sensor placed in their knee anterior knee compartment during their surgery. This sensor will record pressure data following a patient's surgical treatment for 18+ hours.",null,[19,20,21],"Proximal Tibia Fracture","Tibial Shaft Fracture","Acute Compartment Syndrome",[23,24,25,26],"Tibia fracture","acute compartment syndrome","compartment pressure","pediatric","INTERVENTIONAL","DIAGNOSTIC",[30],"NA",{"count":32,"type":33},50,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Continuous Compartmental Pressure Monitor","All study participants will have a continuous compartmental pressure monitor placed in the operating room. The pressure sensor will be inserted into the anterior knee compartment, and will remain in place for a minimum of 18 hours postoperatively.",[40],"MY01",[42],{"measure":43,"description":44,"timeFrame":45},"Continuous anterior compartment pressure","The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.","From the placement of the MY01 device sensor to 18 hours postoperatively",[47],{"measure":48,"description":49,"timeFrame":50},"Development of acute compartment syndrome","The secondary outcome will be the development of acute compartment syndrome, defined as a clinically diagnosed ACS requiring surgical fasciotomy during index hospitalization. This outcome will be analyzed as a binary variable.","From MY01 device insertion to index hospital discharge, up to 1 week postoperatively","ALL","10 Years","21 Years",{"inclusion":55,"exclusion":58,"raw_text":62},[56,57],"Between the ages of 10 to 21 on the day of surgery","Undergoing operative fixation for a fracture of the proximal tibia or tibial shaft",[59,60,61],"Preoperative diagnosis of acute compartment syndrome","Preexisting neuromuscular or vascular condition affecting the injured extremity","MY01 device malfunction","Inclusion Criteria:\n\n* Between the ages of 10 to 21 on the day of surgery\n* Undergoing operative fixation for a fracture of the proximal tibia or tibial shaft\n\nExclusion Criteria:\n\n* Preoperative diagnosis of acute compartment syndrome\n* Preexisting neuromuscular or vascular condition affecting the injured extremity\n* MY01 device malfunction",[64,65],"CHILD","ADULT",[67],{"facility":13,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":78},"Boston","Massachusetts","02115","United States",[73],{"name":74,"role":75,"phone":76,"email":77},"Sara Olenich, MS","CONTACT","617-355-6000","sara.olenich@childrens.harvard.edu",{"lat":79,"lon":80},42.35843,-71.05977,[82,86],{"name":83,"role":75,"phone":84,"email":85},"Kristin Livingston, MD","617-355-6021","kristin.livingston@childrens.harvard.edu",{"name":74,"role":75,"phone":76,"email":77},[88],{"name":83,"affiliation":13,"role":89},"PRINCIPAL_INVESTIGATOR",[],[92],{"label":93,"url":94},"Continuous Compartment Pressor Sensor Device Manufacturer","https:\u002F\u002Fmy01.io\u002F",{"nct_id":4,"conditions":96,"biomarkers":99},[97,98],"Compartment Syndrome","Tibia Fracture",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study planning to enroll 50 participants. It is not specified if it is randomized or blinded.","completed","MY01 Pressure Monitoring for Adolescent Tibia Fractures","This study is looking at how pressure changes in the front part of the lower leg (anterior compartment) of adolescents who have broken their shin bone (tibia fracture). We want to see if using a device called MY01, which continuously measures pressure, can help doctors diagnose a serious but rare problem called acute compartment syndrome (ACS). ACS can happen after surgery for a tibia fracture. All participants, aged 10 to 21, will have the MY01 pressure monitor placed during their surgery and it will stay in for at least 18 hours afterward. The main goal is to understand if there are different pressure readings between healthy patients and those who develop ACS, and if this monitoring helps doctors make an accurate diagnosis.","Your anterior compartment pressure will be measured from the placement of the MY01 device sensor to 18 hours postoperatively.",122,"You will have a continuous pressure monitor (MY01 device) placed in your anterior knee compartment during surgery, which will remain for at least 18 hours postoperatively.","Not stated in the trial record.",[],"v2"]