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NCT Number: NCT05445960

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

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Lara Atwater, MD

CONTACT

[email protected]

503-494-6400

About this study

Tourniquets are widely accepted as "safe" for up to two hours of continued use, despite known risks and a paucity of literature supporting this duration. Complications of tourniquets include tourniquet site pain, increased surgical site pain and swelling from reperfusion, neuropraxia, vascular injury, functional weakness, and decreased muscle endurance. Similar to compartment syndrome, tourniquets eliminate the tissue perfusion gradient necessary for oxygen, glucose, and lactic acid exchange. Lack of molecular exchange within the tissue is thought to result in tissue anoxia and acidosis, leading to cellular death of skeletal muscle and nerves. This study randomizes patients undergoing ankle fracture surgery to tourniquet or no-tourniquet arms and studies outcomes including continuous intramuscular pH during and after surgery, and patient-reported outcomes and functional measures up to 3 months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tourniquet

Procedure

This arm will have a tourniquet placed about the thigh and inflated to 250mmHg for the duration of ankle fracture surgery or 2 hours, whichever is shorter.

Primary outcomes

  1. Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks

    Time frame: Collected 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.

  2. Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks

    Time frame: Collected 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.

  3. Change from Baseline Foot and Ankle Ability Measure at 12 weeks

    Time frame: Collected 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).

Secondary outcomes

  1. Pain Score

    Time frame: Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively

    Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)

  2. Malleolar circumference

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    bilateral malleolar circumference in cm will be measured by blinded physical therapists

  3. Calf girth

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    bilateral calf girth in cm will be measured by blinded physical therapists

  4. Mobility

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    Mobility, via timed up and go test in seconds, will be measured by blinded physical therapists. Patients will be seated in a chair and the time to rise, walk 10 feet, turn, walk back to the chair and sit down will be recorded in seconds.

  5. Ankle range of motion

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    ankle range of motion (flexion, extension, inversion, eversion) will be measured in degrees with goniometer by blinded physical therapists

  6. Fatigability

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    Utilizing a biodex machine, fatigability or total work in foot pounds, will be measured by blinded physical therapists

  7. Proximal and distal lower extremity strength

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    proximal and distal lower extremity strength, via handheld dynamometer, in lb will be measured by blinded physical therapists

  8. Single-limb stance time

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    Single-limb stance time (seconds) will be measured by blinded physical therapists

  9. Y-balance test scores

    Time frame: Collected at 6 weeks and 12 weeks postoperatively

    Y-balance test composite score (%) will be measured by blinded physical therapists. For this test, the length of the extremity is measured and the patient reaches the extremity for the longest distance in three planes (anterior, posteriomedial, posterolateral) and the greatest distances achieved are recorded. The score is obtained by the sum of the greatest distances reached in each plane divided by 3x the limb length.

  10. Limb pH

    Time frame: Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively

    a VersaFlex® pH catheter from the Covidien pH monitoring kit will be placed in the anterior compartment of the operative leg via small incision and the Digitrapper® Recorder will measure and record continuous intramuscular pH

Study contacts

Contact information is provided by the study sponsor or research team.

Lara Atwater, MD

CONTACT

[email protected]

5034946400

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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