MY01 Pressure Monitoring in Adolescent Tibia Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-21
SponsorBoston Children's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Preoperative diagnosis of acute compartment syndrome
Preexisting neuromuscular or vascular condition affecting the injured extremity
MY01 device malfunction
Trial design
Design model
Single group
Treatments tested in this trial
Continuous Compartmental Pressure Monitor
DeviceAll 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: MY01Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Continuous anterior compartment pressure
The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.
Time frame
From the placement of the MY01 device sensor to 18 hours postoperativelySecondary outcomes
1
Development of acute compartment syndrome
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.
Time frame
From MY01 device insertion to index hospital discharge, up to 1 week postoperativelyOther outcomes
1
Neurovascular status
The third outcome will be clinical neurovascular status at the initial postop visit. This will be defined as a well-perfused limb with normal distal motor and sensory function as described in the clinical note. This outcome will be analyzed as a binary variable (normal neurovascular status or abnormal neurovascular status). Abnormal neurovascular status will subsequently be defined as the presence of any of the following: abnormal motor function, abnormal sensory function, and/or abnormal vascular status.
Time frame
First clinic visit following hospital discharge, average of 2-4 weeks postoperativelySponsors and contacts
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Source ClinicalTrials.gov