Study of Tissue Ultrafiltration Catheters to Prevent Acute Compartment Syndrome in Adults with Severe Tibia Fractures Comparing TUF Treatment to Standard Care with 6-Month Follow-Up

What this Trial Is About

Researchers are evaluating whether tissue ultrafiltration TUF catheters can reduce muscle pressure and prevent acute compartment syndrome ACS in adults aged 18 to 60 who have severe fractures of the upper leg, including the proximal tibia or tibial shaft. The study aims to compare intramuscular pressure levels, the likelihood of developing ACS, the need for fasciotomy surgery, and functional recovery six months after injury between patients receiving TUF catheters and those receiving standard care. It also investigates whether fluid biomarkers collected from the muscle tissue can predict ACS. The study involves 60 participants randomized into two groups one group receives standard care with continuous pressure monitoring of the leg muscle compartment, while the other group receives the same care plus three TUF catheters placed in the injured leg to remove interstitial fluid. Participants must be enrolled within 14 hours of injury or before surgery related to their fracture within 48 hours. Both groups receive ongoing clinical evaluations, and the TUF catheters are connected to a closed suction system to remove fluid from the muscle. During the study, participants will be monitored continuously for muscle pressure and treated according to standard medical practices for their injuries. They will return for a follow-up visit six months after hospital discharge to assess complications, healing progress, muscle function, and patient-reported health outcomes. A subset of patients will provide fluid samples for biomarker analysis. The main outcome measured is the difference in muscle pressure at six months, alongside secondary outcomes like ACS incidence, surgery rates, and physical function improvements.

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