Tourniquet Use for Ankle Fracture Surgery

Overseen By Lara Atwater, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Sepsis, Long bone injuries, others

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

Compensation: Varies

Number of Visits: 4

390 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

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 tourniquet use in improving surgical outcomes for ankle fractures is not clearly supported by the available data. ^{1 2 3 4 5}

Is tourniquet use generally safe for humans?

Tourniquet use during surgery is generally considered safe, but it can increase postoperative swelling and pain, and there are potential risks like vascular compromise (blood flow issues). Proper assessment and understanding of patient history can help prevent unwanted outcomes. ^{1 3 6 7 8}

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

Using a tourniquet during ankle fracture surgery is unique because it provides a bloodless field for the surgeon, which can make the operation easier. However, it may lead to increased swelling and pain after surgery compared to not using a tourniquet. ^{1 2 3 4 7}

Research Team

Lara Atwater, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

Adults aged 18 to 89 who are having surgery for an ankle fracture at OHSU can join this trial. It's not for those with other major bone or internal injuries, including on the same limb, or people with sepsis.

Inclusion Criteria

I am between 18 and 89 years old and having surgery for an ankle fracture at OHSU.

Exclusion Criteria

I have had serious injuries to my bones or internal organs.

I have had sepsis before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo ankle fracture surgery with or without tourniquet use

1 day

1 visit (in-person)

Postoperative Monitoring

Continuous intramuscular pH monitoring and initial recovery

2 hours

Intraoperative and immediate postoperative monitoring

Follow-up

Participants are monitored for functional measures and patient-reported outcomes

12 weeks

Multiple visits (in-person) at 3, 6, and 12 weeks

Treatment Details

Interventions

• Tourniquet

Trial Overview The study is looking at how using a tourniquet during ankle surgery affects muscle pH levels and if there's any link between its use and how well patients recover functionally and what they report about their outcomes after surgery.

Participant Groups

Group I: Tourniquet Active Control 1 Intervention

This arm will have a tourniquet placed around the thigh inflated to 250mmHg for the duration of surgery (until splint placed) or 2 hours, whichever is shorter, during ankle fracture surgery.

Group II: No Tourniquet Active Control 1 Intervention

This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

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

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

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. Estonia pubmed.ncbi.nlm.nih.gov

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