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Purpose

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

Eligibility

Eligible Ages
Between 10 Years and 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Boston Children's Hospital
Boston, Massachusetts 02115
Contact:
Sara Olenich, MS
617-355-6000
sara.olenich@childrens.harvard.edu

More Details

Status
Recruiting
Sponsor
Boston Children's Hospital

Study Contact

Kristin Livingston, MD
617-355-6021
kristin.livingston@childrens.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.