MY01 Pressure Monitoring in Adolescent Tibia Fractures

Conditions

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

Eligibility Criteria

Sex

ALL

Age

10 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Jun 29, 2026

Start date

Aug 17, 2026

Status verified

Aug 2026

Primary completion

Jun 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: MY01
  All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data.

Primary Outcome Measure

Continuous anterior compartment pressure [ Time Frame: From the placement of the MY01 device sensor to 18 hours postoperatively ]

Central Contacts

• Kristin Livingston, MD
  617-355-6021
  [email protected]
• Sara Olenich, MS
  617-355-6000
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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