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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445960
• Other study ID #: STUDY00022560
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: August 17, 2024

Study information

• Verified date: June 2022
• Source: Oregon Health and Science University
• Contact: Lara Atwater, MD
• Phone: 5034946400
• Email: atwaterl[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ankle Fracture - Lateral Malleolus
• Ankle Fracture - Medial Malleolus
• Ankle Fracture, Bimalleolar
• Ankle Fracture, Trimalleolar
• Ankle Fractures
• Ankle Injuries
• Fibula Fracture
• Fractures, Bone
• Syndesmotic Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.

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. — View Citation

Konrad G, Markmiller M, Lenich A, Mayr E, Rüter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. — View Citation

Omeroglu H, Günel U, Biçimoglu A, Tabak AY, Uçaner A, Güney 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. — View Citation

Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcomes Measurement Information System Physical Function Subscale	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	Collected preoperatively and at 3 week, 6 week and 12 week postoperatively
Primary	Patient-Reported Outcomes Measurement Information System Pain Interference Subscale	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	Collected preoperatively and at 3 week, 6 week and 12 week postoperatively
Primary	Foot and Ankle Ability Measure	Foot and Ankle Ability Measure, a Patient Reported Outcome survey used widely in orthopaedic Foot and Ankle literature, will be obtained and reported in points	Collected preoperatively and at 3 week, 6 week and 12 week postoperatively
Secondary	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
Secondary	Malleolar circumference	bilateral malleolar circumference in cm will be measured by blinded physical therapists	Collected at 6 weeks and 12 weeks postoperatively
Secondary	Calf girth	bilateral calf girth in cm will be measured by blinded physical therapists	Collected at 6 weeks and 12 weeks postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Single-limb stance time	Single-limb stance time (seconds) will be measured by blinded physical therapists	Collected at 6 weeks and 12 weeks postoperatively
Secondary	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
Secondary	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