MY01 Pressure Monitoring in Adolescent Tibia Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Compartmental Pressure Monitor.
- Who it may be relevant to
- Registry conditions: Proximal Tibia Fracture, Tibial Shaft Fracture, Acute Compartment Syndrome. Basic parameters: 10 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures
Overview
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
- 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.
Primary outcome measures
- Continuous anterior compartment pressure [Time frame: From the placement of the MY01 device sensor to 18 hours postoperatively]
Secondary outcome measures (1)
- Development of acute compartment syndrome [Time frame: From MY01 device insertion to index hospital discharge, up to 1 week postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT07674043 · P00054215 · 1653422