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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a tourniquet (a tight band that stops blood flow) during ankle surgery affects recovery. Researchers aim to determine if a tourniquet changes pain levels, swelling, and other post-surgery complications. Participants will be randomly divided into two groups: one with a tourniquet and one without. This study targets individuals who have experienced a closed ankle fracture from a simple fall and require surgery. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance surgical outcomes for future patients.

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 prior data suggests that tourniquet use is safe for ankle fracture surgery?

Research has shown that using a tourniquet during ankle fracture surgery raises some safety concerns. Studies have found that while tourniquets can reduce surgery time and blood loss, they might also increase swelling and pain post-surgery. For example, one study found that patients with a tourniquet experienced more swelling afterward compared to those without. Possible risks also include wound problems and blood clots. Although tourniquets can be helpful during surgery, they might cause issues later. Discussing these findings with a healthcare provider is important to determine the best approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using tourniquets in ankle fracture surgeries because they may offer better control of bleeding during the procedure. Most current treatments for ankle fractures, like open reduction and internal fixation, don't typically use tourniquets, potentially leading to more bleeding. By inflating a tourniquet to 250 mmHg, it clamps down on blood vessels, which can make the surgical field clearer and might reduce surgical time and complications. If successful, this approach could enhance surgical outcomes and recovery for patients.

What evidence suggests that using a tourniquet is effective for ankle fracture surgery?

This trial will compare the use of a tourniquet with not using one during ankle fracture surgeries. Studies have shown mixed results regarding tourniquet use in ankle surgery. Some research suggests that a tourniquet can reduce pain and shorten hospital stays. However, other studies found it might increase pain and limit movement after surgery. Concerns also exist about complications such as swelling, wound problems, and blood clots. The effectiveness of tourniquets in ankle fracture surgeries remains debated, with previous findings highlighting both potential benefits and risks. ^{1 2 6 7 8}

Who Is on the Research Team?

Alex Demers, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3878853/

Meta-analysis on the efficacy of tourniquet on ankle trauma ... Smith et al. reported a meta-analysis of the efficacy of the tourniquet on foot and ankle surgery, suggesting that pain was reduced and hospital stay was ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06863688

NCT06863688 | Ankle Fracture Tourniquet Utilization To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251622000199

Tourniquet Use During Open Reduction and Internal ... Tourniquet use in ankle ORIF was associated with a significant increase in postoperative patient reported pain levels, as well as reduced range of motion at 6 ...

4. jfas.org jfas.org/article/S1067-2516(22)00019-9/abstract

Tourniquet Use During Open Reduction and Internal ... The intra-operative use of tourniquet in open reduction and internal fixation (ORIF) of ankle fractures remains a topic of debate.

5. isrctn.com isrctn.com/pdf/91783787

Ankle fracture fixation with or without a tourniquet Some surgeons perform this operation with the use of a tourniquet. This is a cuff device placed around the patient's thigh during surgery.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251624000164

Safety and Outcome Measures of Ankle Open Reduction ... This study describes the safety, cost, and outcomes of patients undergoing ankle fracture repair in an ambulatory surgery center.

7. withpower.com withpower.com/trial/phase-fractures-bone-7-2021-4348d

Tourniquet Use for Ankle Fracture Surgery Tourniquet use during surgery is generally considered safe, but it can increase postoperative swelling and pain, and there are potential risks like vascular ...

8. link.springer.com link.springer.com/article/10.1007/s00590-021-02957-7

The risks associated with tourniquet use in lower limb ... Tourniquet use was associated with greater ankle swelling up to six weeks post-operatively (10 mm versus 19 mm, p < 0.01) compared to surgery ...