Acute Compartment Syndrome, Proximal Tibia Fracture, Tibial Shaft Fracture
Conditions
Keywords
Tibia fracture, acute compartment syndrome, compartment pressure, pediatric
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. 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.
Interventions
DEVICEContinuous 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.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous anterior compartment pressure | From the placement of the MY01 device sensor to 18 hours postoperatively | The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of acute compartment syndrome | From MY01 device insertion to index hospital discharge, up to 1 week postoperatively | The secondary outcome will be the development of acute compartment syndrome, defined as a clinically diagnosed ACS requiring surgical fasciotomy during index hospitalization. This outcome will be analyzed as a binary variable. |
Countries
United States
Contacts
CONTACTKristin Livingston, MD
CONTACTSara Olenich, MS
PRINCIPAL_INVESTIGATORKristin Livingston, MD
Boston Children's Hospital
Outcome results
None listed