[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644761":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":49,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MY01","EXPERIMENTAL","All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data.",[13],"Device: Continuous Compartmental Pressure Monitor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kristin Livingston, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","617-355-6021","kristin.livingston@childrens.harvard.edu",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Sara Olenich, MS","617-355-6000","sara.olenich@childrens.harvard.edu",[35],{"facility":5,"status":20,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Boston","Massachusetts","02115","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-71.05977,42.35843,{"lat":45,"lon":44},[48],{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},{"type":24,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Kristin Livington","Principal Investigator","100644761","my01-pressure-monitoring-in-adolescent-tibia-fractures-100644761",false,"NCT07674043","MY01 Pressure Monitoring in Adolescent Tibia Fractures","Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures","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","ALL","10 Years","21 Years",{"count":63,"type":64},50,"ESTIMATED","INTERVENTIONAL",[67],"NA","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.",[70,71,72],"Proximal Tibia Fracture","Tibial Shaft Fracture","Acute Compartment Syndrome",[74,75,76,77],"Tibia fracture","acute compartment syndrome","compartment pressure","pediatric","NOT_YET_RECRUITING","2026-06-25",{"date":81,"type":82},"2026-06-29","ACTUAL",{"date":84,"type":64},"2026-06-01",{"date":86,"type":64},"2028-06-01",{"name":5,"class":6},1]