MY01 Pressure Monitoring in Adolescent Tibia Fractures

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07674043
Status
Not Yet Recruiting

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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

Start date
Jun 1, 2026
Status verified
Jun 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

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Sara Olenich, MS
[email protected]
617-355-6000

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By research site
Boston Children's Hospital· Boston, MA

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