Tourniquet for Ankle Fractures
Phase-Based Progress Estimates
Effectiveness
Safety
Oregon Health and Science University, Portland, OR
Ankle Fractures+9 More
Tourniquet - ProcedureEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial looks at the effects of using a tourniquet during surgery on muscle function and patient recovery afterwards. The purpose of this trial is to compare the effectiveness of two different types of tourniquets in treating ankle fractures. One group of patients will receive the standard tourniquet, while the other group will receive an experimental tourniquet. There will be no placebo group in this trial.
Eligible Conditions
- Ankle Fractures
- Ankle
- Fracture
- Syndesmotic Injury
- Fibula
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 10 Secondary · Reporting Duration: Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
Week 12
Pain Score
Week 12
Ankle range of motion
Calf girth
Fatigability
Malleolar circumference
Mobility
Proximal and distal lower extremity strength
Single-limb stance time
Y-balance test scores
Week 12
Foot and Ankle Ability Measure
Patient-Reported Outcomes Measurement Information System Pain Interference Subscale
Patient-Reported Outcomes Measurement Information System Physical Function Subscale
Hour 2
Limb pH
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Tourniquet
1 of 2
No Tourniquet
1 of 2
Active Control
390 Total Participants · 2 Treatment Groups
Primary Treatment: Tourniquet · No Placebo Group · N/A
Tourniquet
Procedure
ActiveComparator Group · 1 Intervention: Tourniquet · Intervention Types: ProcedureNo TourniquetNoIntervention Group · 1 Intervention: No Tourniquet · Intervention Types:
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
Closest Location: Oregon Health and Science University · Portland, OR
2012First Recorded Clinical Trial
1 TrialsResearching Ankle Fractures
533 CompletedClinical Trials
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
880 Previous Clinical Trials
6,826,417 Total Patients Enrolled
Lara Atwater, MDPrincipal InvestigatorOregon Health and Science University
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Hung, Man, Judith F. Baumhauer, Frank W. Licari, Maren W. Voss, Jerry Bounsanga, and Charles L. Saltzman. 2018. “PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics”. Foot & Ankle International. SAGE Publications. doi:10.1177/1071100718800304.
- Solonen, Kauko A., Leena Tarkkanen, Sakari Närvänen, and Ruben Gordin. 1968. “Metabolic Changes in the Upper Limb During Tourniquet Ischaemia:a Clinical Study”. Acta Orthopaedica Scandinavica. Medical Journals Sweden AB. doi:10.3109/17453676808989436.
- Younger, Alastair S.E., Timothy P. Kalla, James A. McEwen, and Kevin Inkpen. 2005. “Survey of Tourniquet Use in Orthopaedic Foot and Ankle Surgery”. Foot & Ankle International. SAGE Publications. doi:10.1177/107110070502600305.
- Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.
- Konrad, Gerhard, Max Markmiller, Andreas Lenich, Edgar Mayr, and Axel R??ter. 2005. “Tourniquets May Increase Postoperative Swelling and Pain After Internal Fixation of Ankle Fractures”. Clinical Orthopaedics and Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.blo.0000151849.37260.0a.
- Ömeroĝlu, Hakan, Uĝur Günel, Ali Biçimoĝlu, A. Yalçin Tabak, Ahmet Uçaner, and Ömer Güney. 1997. “The Relationship Between the Use of Tourniquet and the Intensity of Postoperative Pain in Surgically Treated Malleolar Fractures”. Foot & Ankle International. SAGE Publications. doi:10.1177/107110079701801208.
- 2021. "Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445960.
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