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Aspirin for Ankle Fracture Healing

Phase < 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Over 18 years of age
Be older than 18 years old
Must not have
History of bleeding disorder
Pilon fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 - 12 months following surgery
Awards & highlights

Summary

This trial will help to identify if taking aspirin after surgery to fix a fracture delays healing.

Who is the study for?
Adults over 18 with a recent ankle fracture requiring surgery can join this trial. They must be healthy enough for orthopedic surgery and able to consent. Excluded are those with multiple fractures, aspirin allergies, bleeding disorders, or on blood thinners.
What is being tested?
The study is testing if taking aspirin after ankle fracture surgery affects how quickly the bone heals. It's important because while NSAIDs are usually avoided due to concerns they may slow healing, many people take aspirin for other health issues.
What are the potential side effects?
Aspirin may cause side effects like stomach pain, heartburn, nausea, increased risk of bleeding and bruising. Rarely it can lead to severe allergic reactions or significant gastrointestinal problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of bleeding disorders.
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I have a broken shinbone near my ankle.
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I cannot take aspirin due to a specific health reason.
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I have been taking aspirin before joining this study.
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I am unable to understand and give consent for treatment.
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I am under 18 years old.
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I have had multiple broken bones from an injury.
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I am on blood-thinning medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 - 12 months following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 - 12 months following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ankle Fracture Healing
Secondary study objectives
Functional Outcomes
Visual Analog Scale for Pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AspirinExperimental Treatment1 Intervention
250 patients will be randomized to receive Aspirin postoperatively.
Group II: Non-AspirinActive Control1 Intervention
250 patients will be randomized to not receive Aspirin postoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,478 Total Patients Enrolled

Media Library

Aspirin Clinical Trial Eligibility Overview. Trial Name: NCT03765619 — Phase < 1
Ankle Fracture Research Study Groups: Aspirin, Non-Aspirin
Ankle Fracture Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT03765619 — Phase < 1
Aspirin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03765619 — Phase < 1
~23 spots leftby Jan 2025
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