NCT06863688

Ankle Fracture Tourniquet Utilization

Does Tourniquet Utilization Negatively Impact Patient Pain and Outcomes Following Operative Fixation of Rotational Ankle Fractures? A Randomized Clinical Trial.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Alex Demers · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. Patients will be randomized by an Excel random number generator to a tourniquet and non-tourniquet group. Patients will remain blinded to randomization. The treating orthopaedic trauma surgeon will be notified by the PI of the study informing them of the randomization status to ensure appropriate tourniquet utilization the day of surgery. Patients will then undergo standard operative fixation and postoperative management as clinically indicated by the orthopaedic trauma team. Patients will follow-up at 2 weeks and subsequently every 4 weeks as is protocol at our institution. Patient charts will be reviewed for patient and perioperative factors, as well as postoperative complications (i.e. wound complications, need for repeat surgical intervention, and deep vein thrombosis).

Detailed description

Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. II. Tourniquet utilization in the operative fixation of ankle fractures remains controversial and is often subject to surgeon preferences. Despite postulated benefits of minimizing blood loss, decreasing operative times, and improving visualization, tourniquets in ankle fracture fixation have been associated with increased postoperative pain, swelling, decreased range of motion, and increased opioid consumption. Previous literature has demonstrated a nonsignificant increase in wound infections and deep vein thrombosis (DVT) with tourniquet usage. Changes in perfusion intraoperatively and effects of ischemic reperfusion injury have been theorized as drivers of these negative side effects of tourniquets. Perfusion following ankle fracture fixation, thus represents an opportunity to better understand the physiologic implications of tourniquet utilization. Tourniquet use is associated with negative outcomes after total knee arthroplasty (TKA). Despite decreased blood loss, tourniquet use in TKA has been associated with higher VAS pain scores, decreased knee range of motion and functional scores in the early postoperative period, higher rates of thrombotic events, infection, and reoperation. Impaired prosthesis survival, knee function, blood transfusion rates, quality of life, and patient satisfaction bring into question the utility of tourniquet use in TKA. These outcomes have not been thoroughly investigated in the fixation of ankle fractures.

Conditions

• Ankle Fracture

Interventions

Type	Name	Description
DEVICE	Tourniquet	Tourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures.
OTHER	No Tourniquet	No tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures.

Timeline

• Start date: 2024-11-24
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2025-03-07
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study