Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1653422 | Other Grant/Funding Number | Pediatric Orthopaedic Society of North America |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MY01 | Experimental | All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Compartmental Pressure Monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous anterior compartment pressure | The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device. | From the placement of the MY01 device sensor to 18 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From MY01 device insertion to index hospital discharge, up to 1 week postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Livingston, MD | Contact | 617-355-6021 | kristin.livingston@childrens.harvard.edu | |
| Sara Olenich, MS | Contact | 617-355-6000 | sara.olenich@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Livingston, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
| Label | URL |
|---|---|
| Continuous Compartment Pressor Sensor Device Manufacturer | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| First clinic visit following hospital discharge, average of 2-4 weeks postoperatively |