MY01 Pressure Monitoring in Adolescent Tibia Fractures

NCT07674043 | Not Yet Recruiting FDA Device

• 2 other identifiers: P000542151653422
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?
2. 2.Does compartment pressure monitoring aid physicians in accurately diagnosing ACS?

Conditions

Proximal Tibia Fracture; Tibial Shaft Fracture; Acute Compartment Syndrome

Keywords

Tibia fracture; acute compartment syndrome; compartment pressure; pediatric

Outcome Measures

Primary Outcomes (1)

• Continuous anterior compartment pressure

  The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.

  From the placement of the MY01 device sensor to 18 hours postoperatively

Secondary Outcomes (1)

• Development of acute compartment syndrome

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

Other Outcomes (1)

• Neurovascular status

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

Study Arms (1)

MY01

EXPERIMENTAL

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

Device: Continuous Compartmental Pressure Monitor

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.

MY01

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Preoperative diagnosis of acute compartment syndrome
• Preexisting neuromuscular or vascular condition affecting the injured extremity
• MY01 device malfunction

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Continuous Compartment Pressor Sensor Device Manufacturer

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Kristin Livingston, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Livingston, MD

CONTACT

617-355-6021; kristin.livingston@childrens.harvard.edu

Sara Olenich, MS

CONTACT

617-355-6000; sara.olenich@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

US (1)