Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT05445960

Conditions

Ankle Fractures

Ankle Fracture - Lateral Malleolus

Ankle Fracture, Bimalleolar

Ankle Fracture, Trimalleolar

Ankle Fracture - Medial Malleolus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tourniquet

Study Details

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.

Conditions

Ankle Fractures

Ankle Fracture - Lateral Malleolus

Ankle Fracture, Bimalleolar

Ankle Fracture, Trimalleolar

Ankle Fracture - Medial Malleolus

Study ID

NCT05445960

Start date

Aug 17, 2021

Status verified date

Mar, 2025

Completion date

Mar 17, 2027

Anticipated

Primary completion date

Mar 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks [ Time Frame: Collected preoperatively and 12 weeks postoperatively ]
  • Change from Baseline Foot and Ankle Ability Measure at 12 weeks [ Time Frame: Collected preoperatively and 12 weeks postoperatively ]

Central Contacts and Locations

Central contacts

Lara Atwater, MD

5034946400atwaterl@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Lara Atwater, MD

503-494-6400atwaterl@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-03-24.