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

NCT05889559 | Recruiting FDA Device

• 1 other identifier: IRB00268346
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.

  Proportion of patients with a of Change in continuously measured IMP.

  6 months post injury

Secondary Outcomes (4)

• 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.

  6 months post injury

• To test whether TUF reduces the incidence of fasciotomy compared to control patients.

  6 months post injury

• To test the impact of TUF on improving patient Global Health

  6 months post injury

• To test the impact of TUF on improving patient physical function

  6 months post injury

Study Arms (2)

Control Pressure Monitoring Group

NO INTERVENTION

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.

Tissue Ultrafiltration Intervention Group (TUF)

EXPERIMENTAL

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.

Device: Tissue Ultrafiltration Catheters

Interventions

Tissue Ultrafiltration Catheters DEVICE

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.

Tissue Ultrafiltration Intervention Group (TUF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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)
• Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).
• Patients with known peripheral vascular disease
• Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.
• Very low clinical concern for ACS at time of admission.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (4)

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

Baltimore, Maryland, 21201, United States

RECRUITING

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415-1623, United States

RECRUITING

Atrium Health Musculoskeletal Institute

Charlotte, North Carolina, 28207, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Tibial Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Central Study Contacts

Dana Alkhoury, MPH

CONTACT

(410) 955-7498; dalkhou1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 5, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (4)