NCT05445960 · Oregon Health and Science University
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Tourniquet
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 outcome measures
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.
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.
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU
Exclusion criteria
- other significant long bone or internal injuries (including ipsilateral limb injuries).
Where
- Portland, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2025 · Source of record for eligibility and locations