Ankle Fracture Tourniquet Utilization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-24

Study Completion Date

2026-07-30

Brief Summary

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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).

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Detailed Description

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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

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Ankle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Tourniquet

Intervention Type DEVICE

Tourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures.

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.

Group Type OTHER

No Tourniquet

Intervention Type OTHER

No tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures.

Interventions

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Tourniquet

Tourniquets will be applied to the thigh of the operative extremity during operative fixation of ankle fractures.

Intervention Type DEVICE

No Tourniquet

No tourniquet will be inflated on the operative extremity during the operative fixation of ankle fractures.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No