NCT06863688

Ankle Fracture Tourniquet Utilization

ENROLLING BY INVITATION NA Last updated 17 February 2026

What this trial tests

NA trial testing Tourniquet in Ankle Fracture in 100 participants. Enrolling by invitation.

Timeline

24 November 2024

Primary endpoint
30 June 2026

30 July 2026

Quick facts

Lead sponsor	Alex Demers
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	24 November 2024
Primary completion	30 June 2026
Estimated completion	30 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Tourniquet
• No Tourniquet

Conditions studied

• Ankle Fracture — all drugs for Ankle Fracture →

Sponsor

Alex Demers

Who can join

Adults 18 to 65, any sex, with Ankle Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.