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RECRUITING Not applicable ClinicalTrials.gov

MY01 Pressure Monitoring in Adolescent Tibia Fractures

Sponsor: Boston Children's Hospital • ClinicalTrials.gov ID: NCT07674043

Registry updated: 2026-08-27
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Description

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.

Interventions

  • Continuous Compartmental Pressure Monitor (Device)
    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.

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

Conditions

Proximal Tibia Fracture Tibial Shaft Fracture Acute Compartment Syndrome

Locations

  • Boston Children's Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record