Compartment Syndrome Clinical Trials

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Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Kristin Livingston, MD
kristin.livingston@childrens.harvard.edu
617-355-6021
Backup
Sara Olenich, MS
sara.olenich@childrens.harvard.edu
617-355-6000
Time Frame
Start Date: 2026-08-17
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 50
Treatments
Experimental: MY01
All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data.
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov