Clinical trial NCT06863688: Ankle Fracture Tourniquet Utilization
Official title: Does Tourniquet Utilization Negatively Impact Patient Pain and Outcomes Following Operative Fixation of Rotational Ankle Fractures? a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ankle Fracture
Keywords: Ankle Fracture
Tourniquet
PROM
Pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing operative fixation of ankle fractures will be randomized to the tourniquet and no tourniquet groups in a 1:1 fashion. The treating orthopaedic trauma surgeon will be informed of the randomization status the day of surgery by the PI to ensure appropriate tourniquet utilization is executed during surgery.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale Pain Levels
timeFrame: Post anesthesia recovery unit, 2 weeks postoperatively, 3 month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores
timeFrame: 6 weeks, 3 months
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Cat V2.0 Physical Function Score
timeFrame: 6 weeks, 3 month
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Scale V1.2 Global Health Score
timeFrame: 6 weeks, 3 months
measure: Optimal Screening for Prediction of Referral and Outcome (OSPRO) Yellow Flag 17-Item
timeFrame: 2 weeks, 6 weeks, 3 months
Secondary outcomes:
measure: Postoperative Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Alex Demers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.