Examining the effects of tourniquet use during ankle fracture surgery on recovery outcomes
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
This study is testing if using a tourniquet during ankle fracture surgery affects recovery and muscle health compared to not using one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05445960 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of intraoperative tourniquet use on skeletal muscle pH and postoperative outcomes in patients undergoing ankle fracture surgery. Patients will be randomized into two groups: one receiving a tourniquet during surgery and the other not. The study will measure continuous intramuscular pH levels during and after the procedure, as well as functional measures and patient-reported outcomes up to three months post-surgery. The goal is to better understand the risks associated with tourniquet use and its effects on recovery.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 to 89 who are scheduled for surgical fixation of an ankle fracture.
Not a fit: Patients with sepsis or significant long bone/internal injuries, including ipsilateral limb injuries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical practices and better recovery outcomes for patients undergoing ankle fracture surgery.
How similar studies have performed: While the use of tourniquets is common, there is limited literature on their effects, making this study's approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Portland, Oregon
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Lara Atwater, MD — Oregon Health and Science University
- Study coordinator: Lara Atwater, MD
- Email: atwaterl@ohsu.edu
- Phone: 5034946400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.