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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MY01 Pressure Monitoring in Adolescent Tibia Fractures
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kristin Livingston, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.