Proximal Tibia FractureNCT07674043
MY01 Pressure Monitoring in Adolescent Tibia Fractures
A study testing Continuous Compartmental Pressure Monitor in people with Proximal Tibia Fracture and Tibial Shaft Fracture, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Proximal Tibia Fracture, Tibial Shaft Fracture, Acute Compartment Syndrome
- What is being tested?
- Continuous Compartmental Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Preoperative diagnosis of acute compartment syndrome
- Preexisting neuromuscular or vascular condition affecting the injured extremity
- MY01 device malfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Sara Olenich, MS, 617-355-6000, sara.olenich@childrens.harvard.edu
About this study
Official title: Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures
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:
Read more
- Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?
- 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.
- Being tested
- Continuous Compartmental Pressure Monitor
- Keywords
- Tibia fracture, acute compartment syndrome, compartment pressure, pediatric
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Compartmental Pressure MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MY01 | Experimental | All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data. Receives: Device: Continuous Compartmental Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous anterior compartment pressure
The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.
Measured: From the placement of the MY01 device sensor to 18 hours postoperatively
Secondary 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.
Measured: From MY01 device insertion to index hospital discharge, up to 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start17 Aug 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Tibia FractureStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Livington, Boston Children's Hospital
- Investigators
- Kristin Livingston, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674043
- Sponsor's protocol ID
- IRB-P00054215
- Other IDs
- 1653422
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures
- ClinicalTrials.gov ID
- NCT07674043
- Acronym / sponsor ID
- IRB-P00054215
- Keywords
- Tibia fracture, acute compartment syndrome, compartment pressure, pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MY01 | Experimental | Device: Continuous Compartmental Pressure MonitorAll study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Preoperative diagnosis of acute compartment syndrome
- Preexisting neuromuscular or vascular condition affecting the injured extremity
- MY01 device malfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Compartmental Pressure MonitorAll 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. | Device | MY01 |
Primary outcome
Continuous anterior compartment pressure
Time frame: From the placement of the MY01 device sensor to 18 hours postoperatively
The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.
1 secondary outcome
Development of acute compartment syndrome
Time frame: From MY01 device insertion to index hospital discharge, up to 1 week postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Continuous Compartment Pressor Sensor Device ManufacturerLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Livingston, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Compartmental Pressure Monitor in people with Proximal Tibia Fracture and Tibial Shaft Fracture, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Livingston, MD (617-355-6021, kristin.livingston@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous anterior compartment pressure (time frame: From the placement of the MY01 device sensor to 18 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.