MY01 Pressure Monitoring in Adolescent Tibia Fractures

Starting soon · Not applicable

Conditions studied: Proximal Tibia Fracture, Tibial Shaft Fracture, Acute Compartment Syndrome

In brief

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.

Key facts

Study ID

NCT07674043

Run by

Boston Children's Hospital

People needed

50

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-29

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Preoperative diagnosis of acute compartment syndrome
• Preexisting neuromuscular or vascular condition affecting the injured extremity
• MY01 device malfunction

Where it is running

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

Full record on ClinicalTrials.gov

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