MY01 Pressure Monitoring for Adolescent Tibia Fractures

This study is looking at how pressure changes in the front part of the lower leg (anterior compartment) of adolescents who have broken their shin bone (tibia fracture). We want to see if using a device called MY01, which continuously measures pressure, can help doctors diagnose a serious but rare problem called acute compartment syndrome (ACS). ACS can happen after surgery for a tibia fracture. All participants, aged 10 to 21, will have the MY01 pressure monitor placed during their surgery and it will stay in for at least 18 hours afterward. The main goal is to understand if there are different pressure readings between healthy patients and those who develop ACS, and if this monitoring helps doctors make an accurate diagnosis.

Study design
This is an interventional study planning to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
You will have a continuous pressure monitor (MY01 device) placed in your anterior knee compartment during surgery, which will remain for at least 18 hours postoperatively.
Compensation
Not stated in the trial record.
Follow-up
Your anterior compartment pressure will be measured from the placement of the MY01 device sensor to 18 hours postoperatively.

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NCT07674043

MY01 Pressure Monitoring in Adolescent Tibia Fractures

Not Yet Recruiting
NAAges 10–21InterventionalDiagnostic
Boston Children's Hospital
~50 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Continuous Compartmental Pressure Monitor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Continuous anterior compartment pressure
Measured over From the placement of the MY01 device sensor to 18 hours postoperatively
Proximal Tibia Fracture
Tibial Shaft Fracture
Acute Compartment Syndrome
1 sites across 1 states
Massachusetts1
  • Kristin Livingston, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

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

Preoperative diagnosis of acute compartment syndrome
Preexisting neuromuscular or vascular condition affecting the injured extremity
MY01 device malfunction
  • Continuous anterior compartment pressureFrom the placement of the MY01 device sensor to 18 hours postoperatively

    The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.