Clinical trial Recruiting at 1 site Interventional Ages 10 to 21

Monitoring leg pressure in teens with tibia fractures

Official title: Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures

Run by Boston Children's Hospital · NCT07674043 · Data updated 2026-11-12

A sensor is placed during surgery to see if measuring anterior leg pressure can help doctors spot acute compartment syndrome in teens with tibia fractures.

Quick facts

Study typeInterventional
Ages10 Years to 21 Years
SexAll
Enrollment50 (estimated)
SponsorBoston Children's Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedAugust 17, 2026
Main results expectedJune 1, 2028
Study endsJune 1, 2028
Registry record updatedOctober 23, 2026
Trial IDNCT07674043 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 10–21 undergoing operative fixation for proximal tibia or tibial shaft fractures without preexisting ACS or neuromuscular/vascular conditions.

Probably not a fit

Patients with preoperative ACS, certain neuromuscular/vascular conditions, or those for whom the device malfunctions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests whether continuous anterior leg compartment pressure monitoring in adolescents who undergo fixation of proximal tibia or tibial shaft fractures can distinguish those who develop acute compartment syndrome from those who do not. The device records pressure for about 18 hours after surgery to see if pressure patterns correlate with ACS diagnosis. The study is conducted at Boston Children's Hospital and involves patients aged 10–21, with specific exclusions to avoid those with preexisting conditions or device issues. Results could help determine if pressure monitoring improves ACS diagnosis after tibia fracture treatment.

Why it matters

Potential benefit: If successful, monitoring could help doctors detect ACS earlier and more accurately, potentially preventing complications.

How similar studies have gone: Previous studies with similar monitoring approaches have explored ACS detection, but this specific pediatric tibia fracture setting is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Boston Children's Hospital
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Tissue ultrafiltration to prevent acute compartment syndrome after severe tibia fractures

    This trial tests whether placing tissue ultrafiltration (TUF) catheters in adults 18–60 with severe proximal tibia or tibial shaft fractures can lower muscle pressure and prevent acute compartment syndrome compared with standard care.

    Recruiting at 4 sites Major Extremity Trauma Research Consortium · Baltimore, Maryland and 3 other locations · NCT05889559

  • Research on Acute Compartment Syndrome after Femoropopliteal Arterial Injuries

    This study looks at how often people develop Acute Compartment Syndrome after injuries to the femoropopliteal artery and what that means for their treatment and recovery.

    Recruiting Hebei Medical University Third Hospital · Shijiazhuang, Hebei · NCT05030259

  • Research on Acute Compartment Syndrome

    This study looks at how to better diagnose and treat acute compartment syndrome in adults with certain types of serious leg fractures to see if surgery is needed.

    Recruiting Hebei Medical University Third Hospital · Shijiazhuang, Hebei · NCT04529330

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.