Tissue ultrafiltration to prevent acute compartment syndrome after severe tibia fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dalkhou1@jhu.edu
• Phone: (410) 955-7498

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing knee osteoarthritis in patients with tibial plateau fractures in Norrbotten

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.