About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU
Disqualifiers
sepsis
other significant long bone or internal injuries (including ipsilateral limb injuries).
Trial design
Parallel
Treatments tested in this trial
Tourniquet
Procedure/SurgeryThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
Secondary outcomes
Pain Score
Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)
Malleolar circumference
bilateral malleolar circumference in cm will be measured by blinded physical therapists
Calf girth
bilateral calf girth in cm will be measured by blinded physical therapists
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.
Sponsors and contacts
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