Double Blinded, Randomized Clinical Trial of the Twin Star ECSPRESS Monitoring System for the Reduction of the Incidence of Fasciotomy

Eligible patients who are enrolled in the study will receive standard surgical stabilization
within 72 hours of injury. All Subjects will receive the Twin Star ECSPRESS catheters, which
will be inserted at the end of the surgical procedure to stabilize the tibia fracture and
will be connected to the pressure monitor in the operating room or immediately upon arrival
in the recovery room. The catheters will be used for up to 24-hours after surgical fixation
of the affected lower leg in order to (1) measure and record muscle compartment pressure,
and (2) remove interstitial fluid in the subset of subjects that are randomized to the
Treatment Group. Subjects will be followed closely during the 24 hours the catheter is
inserted to gather muscle pressure data, occurrance of a fasciotomy, adverse events, etc.
and then followed up at 2 weeks, 3 months, 6 months and 12 months post study enrollment
after which the subjects participation in the study will be completed. There will no interim
data analysis of the study outcomes during the conduct of this study. Data analysis and
presentation of the data will be made after study closure.

Inclusion Criteria:

- • Subject with an isolated tibial shaft fracture requiring intramedullary nailing, or
bicondylar tibial plateau fracture or tibial plateau fracture-knee dislocation
requiring application of a knee-spanning external fixator. OR Subject with an
isolated tibial shaft fracture requiring intramedullary nailing, or bicondylar tibial
plateau fracture or tibial plateau fracture-knee dislocation requiring application of
a knee-spanning external fixator AND another major fracture in a different body
region or injuries to one other major organ system (head, chest, abdomen, pelvis,
genitourinary, or spine) excluding those with injuries to the opposite leg that would
preclude them from completing required tests (see exclusion criteria).

- • Subject with an isolated tibial shaft fracture requiring intramedullary nailing, or
bicondylar tibial plateau fracture or tibial plateau fracture-knee dislocation
requiring application of a knee-spanning external fixator AND another major fracture
in a different body region or injuries to one other major organ system (head, chest,
abdomen, pelvis, genitourinary, or spine) excluding those with injuries to the
opposite leg that would preclude them from completing required tests (see exclusion
criteria).

All Subjects

- Operative procedure (nailing or external fixation) performed within 72 hours of
injury.

- The Subject is at least 18 years of age and no older than 44 years of age. Subject or
legally acceptable representative must able to understand what he/she is being asked
to do, willing/able to understand and sign the Informed Consent to return for the
required follow-up visits at 2 weeks, 3 months, 6 months, and 12 months post-surgery.
A legally acceptable representative may sign the Informed Consent on the patient's
behalf.

- In the study investigators opinion, patient's co-morbidity condition(s) at enrollment
WILL allow patient to return and complete the required testing for all return visits
for the duration of this 12-month clinical study.

Exclusion Criteria:

- • Current evidence of CS prior to the decision regarding enrollment. Surgical
stabilization that resulted in the presence of a bead pouch, VAC, negative-pressure
wound therapy device, or other dressing that would interfere with placement of any of
the four catheters in the anterior deep posterior compartments.

- The Subject has a medical condition(s) that precludes use of catheters, such as
dermatologic conditions, immunological deficits, or traumatic skin lesions that
interfere with Catheter placement.

- An Injury to the ipsilateral knee, ankle, and/or foot that would influence
results of muscle testing.

- Opposite leg knee injury or tibia, ankle, foot fracture, or any other injury
that would preclude or influence the results of mechanical muscle testing.

- Incision into the anterior or deep posterior compartments of the leg to be
studied that would release the fascia as this would constitute a partial
fasciotomy and would affect leg pressures.

- The Subject is currently enrolled in one or more clinical studies.

- Likely problems, in the investigator's judgment, with maintaining follow-up
(including developmental delay, address greater than 2 hours drive from the
treating institution, substance abuse problems, intoxication, current or pending
incarceration, etc.).