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NCT07674043
MY01 Pressure Monitoring in Adolescent Tibia Fractures
Conditions: Proximal Tibia Fracture, Tibial Shaft Fracture, Acute Compartment Syndrome
Sex: All
Ages: 10 Years – 21 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Boston Children's Hospital
Location: Boston Children's Hospital Boston Massachusetts
Summary
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.
The main questions it aims to answer are:
1. Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?
2. Does compartment pressure monitoring aid physicians in accurately diagnosing ACS?
Participants 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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Preoperative diagnosis of acute compartment syndrome
* Preexisting neuromuscular or vascular condition affecting the injured extremity
* MY01 device malfunction
Source: ClinicalTrials.gov (NCT07674043). StuddyBuddy aggregates publicly available trial information.