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Ankle FracturesNCT05445960

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

A study testing Tourniquet in people with Ankle Fractures and Ankle Fracture - Lateral Malleolus, run by Oregon Health and Science University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
Tourniquet
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
1 siteUnited States
Study dates
17 Aug 2021to 17 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lara Atwater, MD contact

5034946400

atwaterl@ohsu.edu

United States1 site, 1 recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Lara Atwater, MD, 503-494-6400, atwaterl@ohsu.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Tourniquet
Medical subject headings
Ankle Fractures, Fibula Fractures, Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TourniquetProcedure or surgery

    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.

Study groups in NCT05445960
Study groupRoleWhat they receive
TourniquetActive comparatorThis 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.
Receives: Procedure: Tourniquet
No TourniquetNo interventionThis arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Collected preoperatively and 12 weeks postoperatively

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

    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.

    Measured: Collected preoperatively and 12 weeks postoperatively

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

    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).

    Measured: Collected preoperatively and 12 weeks postoperatively

Secondary outcomes (10)

  1. Pain Score

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

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

  2. Malleolar circumference

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

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  3. Calf girth

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

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  4. Mobility

    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.

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  5. Ankle range of motion

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

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  6. Fatigability

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

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  7. Proximal and distal lower extremity strength

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

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  8. Single-limb stance time

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

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  9. Y-balance test scores

    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.

    Measured: Collected at 6 weeks and 12 weeks postoperatively

  10. Limb pH

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start17 Aug 2021
  3. Primary completion17 Mar 2026 (estimated)
  4. Study completion17 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445960
Sponsor's protocol ID
STUDY00022560
Status last verified
Mar 2025
First submitted
10 May 2022
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Omeroglu H, Gunel U, Bicimoglu A, Tabak AY, Ucaner A, Guney O. The relationship between the use of tourniquet and the intensity of postoperative pain in surgically treated malleolar fractures. Foot Ankle Int. 1997 Dec;18(12):798-802. doi: 10.1177/107110079701801208.

    PubMed 9429882

  • Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a.

    PubMed 15805957

  • Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305.

    PubMed 15766423

  • Hung M, Baumhauer JF, Licari FW, Voss MW, Bounsanga J, Saltzman CL. PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics. Foot Ankle Int. 2019 Jan;40(1):65-73. doi: 10.1177/1071100718800304. Epub 2018 Oct 4.

    PubMed 30282469

  • Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. No abstract available.

    PubMed 5114697

  • Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.

Questions about this trial

What is this clinical trial studying?

A study testing Tourniquet in people with Ankle Fractures and Ankle Fracture - Lateral Malleolus, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lara Atwater, MD (5034946400, atwaterl@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks (time frame: Collected preoperatively and 12 weeks postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05445960, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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