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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures; Ankle Fracture - Lateral Malleolus; Syndesmotic Injuries; Ankle Fracture, Trimalleolar; Ankle Fracture, Bimalleolar; Fibula Fracture; Ankle Fracture - Medial Malleolus; Maisonneuve's Fracture
• Intervention / Treatment: Procedure: Tourniquet

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 Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lara Atwater, MD; Phone Number: 5034946400; Email: atwaterl@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
      • Contact: Lara Atwater, MD; Phone Number: 503-494-6400; Email: atwaterl@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
No Intervention: No Tourniquet; This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Collected preoperatively and 12 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Patients will score their pain on a Visual Analog pain scale (VAS) (0-10)	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	Collected at 6 weeks and 12 weeks postoperatively
Calf girth	bilateral calf girth in cm will be measured by blinded physical therapists	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.	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	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	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	Collected at 6 weeks and 12 weeks postoperatively
Single-limb stance time	Single-limb stance time (seconds) will be measured by blinded physical therapists	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.	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	Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Lara Atwater, MD, Oregon Health and Science University

Publications and helpful links

General Publications

• Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a.
• Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305.
• Omeroglu H, Gunel U, Bicimoglu A, Tabak AY, Ucaner A, Guney O. The relationship between the use of tourniquet and the intensity of postoperative pain in surgically treated malleolar fractures. Foot Ankle Int. 1997 Dec;18(12):798-802. doi: 10.1177/107110079701801208.
• Hung M, Baumhauer JF, Licari FW, Voss MW, Bounsanga J, Saltzman CL. PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics. Foot Ankle Int. 2019 Jan;40(1):65-73. doi: 10.1177/1071100718800304. Epub 2018 Oct 4.
• Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. No abstract available.
• Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Estimated): March 17, 2026
• Study Completion (Estimated): March 17, 2027

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fibula Fractures; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: STUDY00022560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No