The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome (ACS) in adults ages 18-60 with severe proximal tibia or tibial shaft fractures.
The main questions it aims to answer are:
Will intramuscular pressure (IMP) be lower in the TUF cohort compared to controls?
Will the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort?
Are interstitial fluid biomarkers predictive of ACS?
Researchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery.
Participants will:
Be enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours.
Receive continuous anterior compartment pressure monitoring.
Undergo standard-of-care clinical evaluation and treatment.
(TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid.
Return for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes.
(Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.
Between the ages of 18 and 60 years
Have sustained a high-energy upper leg injury such as open or closed proximal tibial shaft fracture with displacement, comminution, or segmental pattern; proximal fibula fracture; bicondylar tibial plateau fracture; Schatzker IV medial knee fracture-dislocation; proximal leg injury due to shotgun, rifle, or other projectile, or severe crushing injury.
Patient can be enrolled in the study and study procedures initiated within 14 hours of injury,* or be enrolled prior to undergoing urgent surgical intervention on the injured limb (defined as internal or external fixation) within 48 hours of admission.
Patient (or authorized legal representative) willing to sign informed consent.
Patients not willing to participate
Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)
Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended
Soft tissue wounds, including lacerations or abrasions, that are in a location that will interfere with safe insertion of indwelling pressure or TUF catheters (anterior - anterolateral aspect of the leg)
Parallel
Tissue Ultrafiltration Catheters
Devicepatients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle.
To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.
Proportion of patients with a of Change in continuously measured IMP.
To test whether there are differences in the incidence of ACS in patients with severe leg injuries treated with active TUF compared to the control group.
The consensus likelihood of ACS as assessed by a panel of experts after review of a standardized patient profile.
To test whether TUF reduces the incidence of fasciotomy compared to control patients.
Proportion of patients with a fasciotomy.
To test the impact of TUF on improving patient Global Health
Veteran Rand 12 Health Survey (VR12)
To test the impact of TUF on improving patient physical function
PROMIS Physical Function
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