NCT07674043 MY01 Pressure Monitoring in Adolescent Tibia Fractures
| NCT ID | NCT07674043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Proximal Tibia Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-08-17 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-08-17 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kristin Livingston, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT07674043 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 21 Years, studying Proximal Tibia Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07674043 currently recruiting?
Yes, NCT07674043 is actively recruiting participants. Contact the research team at kristin.livingston@childrens.harvard.edu for enrollment information.
Where is the NCT07674043 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07674043 clinical trial?
NCT07674043 is sponsored by Boston Children's Hospital. The principal investigator is Kristin Livingston, MD at Boston Children's Hospital. The trial plans to enroll 50 participants.