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NCT Number: NCT07674043

MY01 Pressure Monitoring in Adolescent Tibia Fractures

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.

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Key information

Conditions

Proximal Tibia Fracture Acute Compartment Syndrome Fractures, Bone Leg Injuries Tibial Fractures Tibial Shaft Fracture Wounds and Injuries

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Compartmental Pressure Monitor

Device

All study participants will have a continuous compartmental pressure monitor placed in the operating room. The pressure sensor will be inserted into the anterior knee compartment, and will remain in place for a minimum of 18 hours postoperatively.

Primary outcomes

  1. Continuous anterior compartment pressure

    Time frame: From 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.

Secondary outcomes

  1. Development of acute compartment syndrome

    Time frame: From MY01 device insertion to index hospital discharge, up to 1 week postoperatively

    The secondary outcome will be the development of acute compartment syndrome, defined as a clinically diagnosed ACS requiring surgical fasciotomy during index hospitalization. This outcome will be analyzed as a binary variable.

Other outcomes

  1. Neurovascular status

    Time frame: First clinic visit following hospital discharge, average of 2-4 weeks postoperatively

    The third outcome will be clinical neurovascular status at the initial postop visit. This will be defined as a well-perfused limb with normal distal motor and sensory function as described in the clinical note. This outcome will be analyzed as a binary variable (normal neurovascular status or abnormal neurovascular status). Abnormal neurovascular status will subsequently be defined as the presence of any of the following: abnormal motor function, abnormal sensory function, and/or abnormal vascular status.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Livingston, MD

CONTACT

[email protected]

617-355-6021

Sara Olenich, MS

CONTACT

[email protected]

617-355-6000

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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