Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery

Not Applicable

Recruiting

• Conditions: Maisonneuve's Fracture; Ankle Fracture, Trimalleolar; Ankle Fracture - Lateral Malleolus; Ankle Fractures; Syndesmotic Injuries; Ankle Fracture, Bimalleolar; Ankle Fracture - Medial Malleolus; Fibula Fracture
• Interventions: Procedure: Tourniquet

• Registration Number: NCT05445960
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-03-17
• Study Completion: 2027-03-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tourniquet	Tourniquet	This arm will have a tourniquet placed around the thigh inflated to 250mmHg for the duration of surgery (until splint placed) or 2 hours, whichever is shorter, during ankle fracture surgery.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks	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	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	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).

Secondary Outcome Measures

Name	Time	Method
Pain Score	Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively	Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)
Mobility	Collected at 6 weeks and 12 weeks postoperatively	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.
Fatigability	Collected at 6 weeks and 12 weeks postoperatively	Utilizing a biodex machine, fatigability or total work in foot pounds, will be measured by blinded physical therapists
Malleolar circumference	Collected at 6 weeks and 12 weeks postoperatively	bilateral malleolar circumference in cm will be measured by blinded physical therapists
Limb pH	Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively	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
Ankle range of motion	Collected at 6 weeks and 12 weeks postoperatively	ankle range of motion (flexion, extension, inversion, eversion) will be measured in degrees with goniometer by blinded physical therapists
Calf girth	Collected at 6 weeks and 12 weeks postoperatively	bilateral calf girth in cm will be measured by blinded physical therapists
Proximal and distal lower extremity strength	Collected at 6 weeks and 12 weeks postoperatively	proximal and distal lower extremity strength, via handheld dynamometer, in lb will be measured by blinded physical therapists
Single-limb stance time	Collected at 6 weeks and 12 weeks postoperatively	Single-limb stance time (seconds) will be measured by blinded physical therapists
Y-balance test scores	Collected at 6 weeks and 12 weeks postoperatively	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.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States