Ankle Fracture Tourniquet Utilization

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Ankle Fracture
• Intervention / Treatment: Device: Tourniquet; Other: No Tourniquet

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52245
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Patients >18 y.o. undergoing ankle fracture open reduction internal fixation
2. Ground level fall as mechanism of injury
3. Closed injury

Exclusion criteria:

1. Open Ankle Fractures
2. Vascular Injury Requiring Intervention
3. Lower extremity injuries on same side of ankle fracture

e) Active anticoagulation/bleeding disorder necessitating tourniquet use (Hemoglobin <7, PT >13, PTT>35) f) Ipsilateral lower extremity trauma impacting immobilization g) Patients with peripheral neuropathy h) Patients undergoing ankle arthroscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tourniquet Group; Patients randomized to this group will have a tourniquet used during the operative fixation of their ankle fracture. Tourniquets will be inflated to 250 mmHg as is standard for our institution. Tourniquet will be deflated at time of closure.	Device: Tourniquet; Tourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures.
Other: No Tourniquet Group; Patients randomized to this group will not have a tourniquet used during operative fixation of their ankle fracture. A tourniquet will be placed on the patient's operative extremity as a safety precaution, but will remain deflated for the duration of the procedure unless emergently needed for hemostasis.	Other: No Tourniquet; No tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores	Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V1.1 Pain Interference (10-90, lower is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.	6 weeks, 3 months
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V2.0 Physical Function Score	Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V2.0 Physical Function (10-90, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.	6 weeks, 3 month
Patient-Reported Outcome Measurement Information System (PROMIS) Scale V1.2 Global Health Score	Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Scale V1.2 Global Health (15-70, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.	6 weeks, 3 months
Visual Analog Scale Pain Levels	VAS pain scores (0-10) will be assessed for the ankle immediately postoperatively in the post anesthesia care unit and at 2 weeks, 6 weeks and 3 months postoperatively.	Post anesthesia recovery unit, 2 weeks postoperatively, 6 weeks, 3 month follow-up
Optimal Screening for Prediction of Referral and Outcome (OSPRO) Yellow Flag 17-Item	OSPRO-Yf 17 questionnaires will be completed at follow-up appointments as part of standard trauma clinic workflow and will be assessed at 6 weeks, and 3 months.	6 weeks, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complications	Postoperative complications following operative fixation of ankle fractures will be assessed at follow-up appointments and through chart review. Complications include postoperative deep vein thrombosis, wound complications and infection (patients receiving antibiotics or requiring surgical irrigation and debridement), need for revision fixation or hardware removal.	6 months

Collaborators and Investigators

• Sponsor: Alex Demers
• Investigators: Principal Investigator: Alex Demers, MD, University of Iowa

Publications and helpful links

General Publications

• Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13.
• Benedick A, Rivera T, Vallier HA. Effect of Tourniquet Use During Ankle Fracture Fixation on Wound Healing and Infectious Complications. Foot Ankle Int. 2020 Jun;41(6):714-720. doi: 10.1177/1071100720907379. Epub 2020 Mar 1.
• Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a.
• Davey MS, Davey MG, Hurley ET, Kearns SR. Tourniquet Use During Open Reduction and Internal Fixation of Ankle Fractures - A Systematic Review and Meta-Analysis. J Foot Ankle Surg. 2022 Sep-Oct;61(5):1103-1108. doi: 10.1053/j.jfas.2022.01.019. Epub 2022 Jan 23.
• Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12.
• Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pain; PROM; Tourniquet; Ankle Fracture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Ankle Fractures; Equipment and Supplies; Tourniquets
• Other Study ID Numbers: 202311372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared secondary to data sharing regulations at our institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No