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

Last updated: March 19, 2025
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Tourniquet

Clinical Study ID

NCT05445960
STUDY00022560
  • Ages 18-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation atOHSU

Exclusion

Exclusion Criteria:

  • sepsis

  • other significant long bone or internal injuries (including ipsilateral limbinjuries).

Study Design

Total Participants: 390
Treatment Group(s): 1
Primary Treatment: Tourniquet
Phase:
Study Start date:
August 17, 2021
Estimated Completion Date:
March 17, 2027

Study 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.

Connect with a study center

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.