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Ankle Fracture Surgery and Tourniquet Use Study

This study is looking at how using a tourniquet (a device that temporarily stops blood flow to a limb) during ankle fracture surgery affects your recovery. Researchers want to understand if using a tourniquet changes the pH (a measure of acidity) in your leg muscles and how well you recover after surgery. You might be able to join if you are an adult between 18 and 89 years old and are having surgery for an ankle fracture at OHSU. The study will compare patients who have a tourniquet used during their surgery with those who do not. Success will be measured by changes in your physical function, pain levels, and how well you can use your foot and ankle 12 weeks after surgery. The current status of this study is unclear, but it plans to enroll 390 participants.

Study design
This study is interventional and will randomly assign participants to either have a tourniquet used during their ankle fracture surgery or not. It plans to enroll 390 participants.
What's involved
You would have your pH measured in your muscle during and after surgery, and complete questionnaires about your physical function and pain before surgery and 12 weeks after.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after surgery to assess their recovery and outcomes.

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NCT05445960

Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery

Recruiting
NAAges 18–89InterventionalTreatment
Oregon Health and Science University
~390 participants
Updated 2025-03-24 on ClinicalTrials.gov
What's tested:Tourniquet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks
Measured over Collected preoperatively and 12 weeks postoperatively
+2 more outcomes measured

Conditions

Ankle Fractures
Ankle Fracture - Lateral Malleolus
Ankle Fracture, Bimalleolar
Ankle Fracture, Trimalleolar
Ankle Fracture - Medial Malleolus
Maisonneuve's Fracture
Syndesmotic Injuries
Fibula Fracture

Explore related trials

Ankle Fracture

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Lara Atwater, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Lara Atwater, MD
[email protected]
5034946400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU

Exclusion

sepsis
other significant long bone or internal injuries (including ipsilateral limb injuries).

What this trial measures

  • Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 WeeksCollected preoperatively and 12 weeks postoperatively

    Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) subscale, a Patient Reported Outcome survey used widely in orthopaedic literature, will be obtained and reported in points. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). A score of 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For example a score of 40 is one SD lower than the mean of the reference population where as a score of 60 is one SD higher than the mean of the reference population. Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  • Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeksCollected preoperatively and 12 weeks postoperatively

    Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) subscale, a Patient Reported Outcome survey used widely in orthopaedic literature, will be obtained and reported in points. A score of 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For example a score of 40 is one SD lower than the mean of the reference population where as a score of 60 is one SD higher than the mean of the reference population. Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  • Change from Baseline Foot and Ankle Ability Measure at 12 weeksCollected preoperatively and 12 weeks postoperatively

    Foot and Ankle Ability Measure (FAAM), a Patient Reported Outcome survey used widely in orthopaedic Foot and Ankle literature, will be obtained and reported in points. Scores range from 0% (least function) to 100% (most function).