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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05445960
Status
Recruiting
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Conditions

  • Ankle Fracture - Lateral Malleolus
  • Ankle Fracture - Medial Malleolus
  • Ankle Fracture, Bimalleolar
  • Ankle Fracture, Trimalleolar
  • Ankle Fractures
  • Fibula Fracture
  • Maisonneuve's Fracture
  • Syndesmotic Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Tourniquet — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Aug 17, 2021
Status verified
Mar 2025
Primary completion
Mar 17, 2026
Completion
Mar 17, 2027

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • No Intervention: No Tourniquet
    This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

Primary Outcome Measure

Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks [ Time Frame: Collected preoperatively and 12 weeks postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239
Lara Atwater, MD
[email protected]
503-494-6400

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By research site
Oregon Health and Science University· Portland, OR

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