Tissue ultrafiltration to prevent acute compartment syndrome after severe tibia fractures

Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)

This trial tests whether placing tissue ultrafiltration (TUF) catheters in adults 18–60 with severe proximal tibia or tibial shaft fractures can lower muscle pressure and prevent acute compartment syndrome compared with standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Major Extremity Trauma Research Consortium (other)
• Locations: 4 sites (Baltimore, Maryland and 3 other locations)
• Trial ID: NCT05889559 on ClinicalTrials.gov

What this trial studies

Sixty adults with high-energy proximal tibia or tibial shaft fractures will be randomized to receive either three tissue ultrafiltration (TUF) catheters plus standard care or standard care alone. All participants will have continuous anterior compartment pressure monitoring and clinical evaluation, with enrollment occurring within 14 hours of injury or before fracture fixation within 48 hours. The study will compare intramuscular pressure, consensus likelihood of ACS, fasciotomy incidence, interstitial fluid biomarkers, and six-month functional outcomes between groups. Patients will be followed for complications, wound and fracture healing, infection, sensory and motor function, and patient-reported outcomes at six months.

Who should consider this trial

Good fit: Adults 18–60 with high-energy open or closed proximal tibia or tibial shaft fractures judged to be at risk for ACS who can be enrolled within 14 hours of injury or prior to surgery within 48 hours are ideal candidates.

Not a fit: Patients outside the 18–60 age range, those with low-risk fractures, established compartment syndrome at presentation, or those who cannot be enrolled within the specified time windows are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, TUF could lower intramuscular pressure, reduce the need for fasciotomy, and improve recovery after high-energy tibial fractures.

How similar studies have performed: Applying tissue ultrafiltration to prevent ACS is largely novel with limited prior human data, though related pressure-relief and drainage approaches have some preclinical and small pilot support.

Eligibility criteria

INCLUSION CRITERIA The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of admission by virtue of their mechanism of injury, fracture pattern, clinical signs, or need to undergo fracture fixation surgery (internal or external fixation) within 48 hours of admission. Recruitment of participants will happen during hospital admission for treatment of injury.

Eligible patients must meet all of the following criteria and be enrolled during one of two possible times: within 14 hours of injury, or prior to undergoing surgical intervention (internal or external fixation on the injured limb) within 48 hours of admission. Eligible patients will be:

1. Between the ages of 18 and 60 years
2. 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.
3. 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.
4. Patient (or authorized legal representative) willing to sign informed consent.

   * If a patient has an eligible injury and is going to surgery within 2 hours (except for fasciotomy - which is an exclusion criteria), the patient can be enrolled and the study procedures initiated at the end of surgery. If an eligible patient is enrolled and there is no surgery anticipated within 2 hours, initiate study procedures immediately.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients not willing to participate
2. Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)
3. Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended
4. 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)
5. Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).
6. Patients with known peripheral vascular disease
7. Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.
8. Very low clinical concern for ACS at time of admission.

Where this trial is running

Baltimore, Maryland and 3 other locations

• University of Maryland School of Medicine R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (RECRUITING)
• Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (RECRUITING)
• Atrium Health Musculoskeletal Institute — Charlotte, North Carolina, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Study coordinator: Dana Alkhoury, MPH

Conditions: Acute Compartment Syndrome, Fracture, Bone, Tibial Fractures