MY01 Pressure Monitoring in Adolescent Tibia Fractures
United States50 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
10 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Continuous anterior compartment pressure
Timeframe: From the placement of the MY01 device sensor to 18 hours postoperatively