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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
390
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.
Oregon Health and Science University
Portland, Oregon, United States
RECRUITINGChange 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.
Time frame: Collected preoperatively and 12 weeks postoperatively
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.
Time frame: Collected preoperatively and 12 weeks postoperatively
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).
Time frame: Collected preoperatively and 12 weeks postoperatively
Pain Score
Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)
Time frame: Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
Malleolar circumference
bilateral malleolar circumference in cm will be measured by blinded physical therapists
Time frame: Collected at 6 weeks and 12 weeks postoperatively
Calf girth
bilateral calf girth in cm will be measured by blinded physical therapists
Time frame: Collected at 6 weeks and 12 weeks postoperatively
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.
Time frame: Collected at 6 weeks and 12 weeks postoperatively
Ankle range of motion
ankle range of motion (flexion, extension, inversion, eversion) will be measured in degrees with goniometer by blinded physical therapists
Time frame: Collected at 6 weeks and 12 weeks postoperatively
Fatigability
Utilizing a biodex machine, fatigability or total work in foot pounds, will be measured by blinded physical therapists
Time frame: Collected at 6 weeks and 12 weeks postoperatively
Proximal and distal lower extremity strength
proximal and distal lower extremity strength, via handheld dynamometer, in lb will be measured by blinded physical therapists
Time frame: Collected at 6 weeks and 12 weeks postoperatively
Single-limb stance time
Single-limb stance time (seconds) will be measured by blinded physical therapists
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Time frame: Collected at 6 weeks and 12 weeks postoperatively
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.
Time frame: Collected at 6 weeks and 12 weeks postoperatively
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
Time frame: Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively