MY01 Pressure Monitoring in Adolescent Tibia Fractures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-21
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Preoperative diagnosis of acute compartment syndrome

Preexisting neuromuscular or vascular condition affecting the injured extremity

MY01 device malfunction

Trial design

Treatments tested in this trial

  • Continuous Compartmental Pressure Monitor

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators