Tourniquet for Ankle Fracture

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alex Demers

Must not be taking: Anticoagulants

Disqualifiers: Open fractures, Vascular injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Immediate (day of surgery)

100 Participants Needed

Trial Summary

What is the purpose of this 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).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Tourniquet for ankle fracture?

The research indicates that using a tourniquet during ankle fracture surgery does not significantly affect hospital stay or operation time, but it may increase postoperative swelling and pain. Therefore, the effectiveness of using a tourniquet for ankle fractures is not clearly supported by the data, as it does not show significant benefits and may have some drawbacks. ^{1 2 3 4 5}

Is tourniquet use generally safe in humans?

Tourniquet use during surgery is common and generally considered safe, but it can lead to complications like wound healing issues and infections. Proper assessment and understanding of risks can help prevent unwanted outcomes, and it is important for the surgical team to be knowledgeable about safe tourniquet use. ^{1 6 7 8 9}

How does using a tourniquet for ankle fracture surgery differ from other treatments?

Using a tourniquet during ankle fracture surgery is unique because it provides a bloodless field, which can help the surgeon see better. However, it may lead to increased swelling and pain after surgery compared to not using a tourniquet. ^{1 2 3 4 10}

Research Team

Alex Demers, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for adults over 18 who've had a ground-level fall resulting in a closed ankle fracture and are undergoing surgery to fix it. It's not for those with other injuries on the same leg, nerve damage, vascular issues needing treatment, open fractures, conditions affecting immobilization or active bleeding disorders.

Inclusion Criteria

Ground level fall as mechanism of injury

Closed injury

Exclusion Criteria

I have injuries on the same leg as my ankle fracture.

I have nerve damage in my hands or feet.

I needed treatment for a blood vessel injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo operative fixation of rotational ankle fractures with or without a tourniquet as per randomization

Immediate (day of surgery)

1 visit (in-person)

Follow-up

Participants are monitored for postoperative complications and pain levels at follow-up appointments

6 months

Follow-up at 2 weeks, then every 4 weeks

Treatment Details

Interventions

• Tourniquet

Trial Overview The study compares postoperative pain and complications between patients having ankle fracture surgery with or without a tourniquet. Participants will be randomly assigned to either group and won't know which one they're in. The surgeon will follow standard procedures after being informed about the assignment.

Participant Groups

Group I: Tourniquet Group Experimental Treatment 1 Intervention

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 II: No Tourniquet Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Alex Demers

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

Tourniquet use during extremity surgery is generally safe, but requires careful assessment of patient history and understanding of risks to prevent complications.

Knowledge of the physiological effects of tourniquets, including their impact on skin, vascular health, and postoperative pain, is essential for improving surgical outcomes and ensuring safe perioperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and Optimizing Tourniquet Use During Extremity Surgery. Jensen, J., Hicks, RW., Labovitz, J.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Tourniquet Use During Ankle Fracture Fixation on Wound Healing and Infectious Complications. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effect on Hospital Length of Stay of Tourniquet Use During Internal Fixation of Ankle Fractures: Randomized Controlled Trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Effect of tourniquet application on postoperative outcomes in sinus tarsi approach for intra-articular calcaneus fractures. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Meta-analysis on the efficacy of tourniquet on ankle trauma surgery. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Time to reconsider the routine use of tourniquets in total knee arthroplasty surgery. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Tourniquet use during plating of acute extra-articular tibial fractures: effects on final results of the operation. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Understanding and Optimizing Tourniquet Use During Extremity Surgery. [2020]

9. Estonia pubmed.ncbi.nlm.nih.gov

Tourniquet in surgery of the limbs: a review of history, types and complications. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The pneumatic ankle tourniquet with ankle block anesthesia for foot surgery. [2019]