Recruiting

TUF

Sponsor:

Major Extremity Trauma Research Consortium

Code:

NCT05889559

Conditions

Acute Compartment Syndrome

Fracture, Bone

Tibial Fractures

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Tissue Ultrafiltration Catheters

Study Details

Brief summary:

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.

Conditions

Acute Compartment Syndrome

Fracture, Bone

Tibial Fractures

Study ID

NCT05889559

Start date

Jan 1, 2024

Status verified date

Aug, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Pressure Monitoring Group

Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants will be treated according to the standard-of-care regarding management of their underlying injury and diagnosis of ACS as practiced by their treating surgeon. Participants will be followed for six months post-injury.

experimental: Tissue Ultrafiltration Intervention Group (TUF)

Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants will be treated according to the standard-of-care regarding management of their underlying injury and diagnosis of ACS as practiced by their treating surgeon. In addition, participants in this group will will undergo three TUF of the anterior compartment of the injured limb. Participants will be followed for six months post-injury.

Interventions

Tissue Ultrafiltration Catheters

patients 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.

Primary outcome measure

  • To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients. [ Time Frame: 6 months post injury ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland School of Medicine R Adams Cowley Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Hennepin Healthcare Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55415-1623

Atrium Health Musculoskeletal Institute

Recruiting

Charlotte, North Carolina, United States, 28207

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Major Extremity Trauma Research Consortium

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2025-08-28.