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NCT07674043NARecruiting

MY01 Pressure Monitoring in Adolescent Tibia Fractures

Boston Children's Hospital

Start Date

8/17/2026

Completion Date

6/1/2028

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

Age Range: 10 years to 21 years

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

Interventions

DEVICE

Continuous Compartmental Pressure Monitor

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Conditions

Proximal Tibia FractureTibial Shaft FractureAcute Compartment Syndrome

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States