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Tourniquet Use for Ankle Fracture Surgery

N/A
Recruiting
Led By Lara Atwater, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU
Be older than 18 years old
Must not have
History of other significant long bone or internal injuries (including ipsilateral limb injuries)
History of sepsis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
Awards & highlights

Summary

This trial looks at the effects of using a tourniquet during surgery on muscle function and patient recovery afterwards.

Who is the study for?
Adults aged 18 to 89 who are having surgery for an ankle fracture at OHSU can join this trial. It's not for those with other major bone or internal injuries, including on the same limb, or people with sepsis.Check my eligibility
What is being tested?
The study is looking at how using a tourniquet during ankle surgery affects muscle pH levels and if there's any link between its use and how well patients recover functionally and what they report about their outcomes after surgery.See study design
What are the potential side effects?
While specific side effects aren't listed, tourniquets may cause discomfort, temporary numbness, swelling in the operated limb, or skin marks where applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 89 years old and having surgery for an ankle fracture at OHSU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had serious injuries to my bones or internal organs.
Select...
I have had sepsis before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Foot and Ankle Ability Measure
Pain
Patient-Reported Outcomes Measurement Information System Physical Function Subscale
Secondary outcome measures
Ankle range of motion
Calf girth
Fatigability
+7 more

Trial Design

2Treatment groups
Active Control
Group I: TourniquetActive Control1 Intervention
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.
Group II: No TourniquetActive Control1 Intervention
This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
985 Previous Clinical Trials
7,385,334 Total Patients Enrolled
Lara Atwater, MDPrincipal InvestigatorOregon Health and Science University

Media Library

Tourniquet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05445960 — N/A
Fibula Fracture Research Study Groups: Tourniquet, No Tourniquet
Fibula Fracture Clinical Trial 2023: Tourniquet Highlights & Side Effects. Trial Name: NCT05445960 — N/A
Tourniquet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445960 — N/A
~0 spots leftby Aug 2024
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