Recruiting

Compartment Pressure Monitoring

Sponsor:

Boston Children's Hospital

Code:

NCT07674043

Conditions

Proximal Tibia Fracture

Tibial Shaft Fracture

Acute Compartment Syndrome

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Interventions

Continuous Compartmental Pressure Monitor

Study Details

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.

Conditions

Proximal Tibia Fracture

Tibial Shaft Fracture

Acute Compartment Syndrome

Study ID

NCT07674043

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MY01

All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data.

Interventions

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 measure

  • Continuous anterior compartment pressure [ Time Frame: From the placement of the MY01 device sensor to 18 hours postoperatively ]

Central Contacts and Locations

Central contacts

Kristin Livingston, MD

617-355-6021kristin.livingston@childrens.harvard.edu

Sara Olenich, MS

617-355-6000sara.olenich@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sara Olenich, MS

617-355-6000sara.olenich@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Tibia fracture
  • acute compartment syndrome
  • compartment pressure
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-08-27.