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MY01 Pressure Monitoring in Adolescent Tibia Fractures

NCT07674043 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-29

No results posted yet for this study

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.

Conditions

  • Proximal Tibia Fracture
  • Tibial Shaft Fracture
  • Acute Compartment Syndrome

Interventions

DEVICE

Continuous Compartmental Pressure Monitor

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.

Sponsors & Collaborators

Principal Investigators

  • Kristin Livingston, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2028-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674043 on ClinicalTrials.gov