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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
All ankle fractures (lateral malleolus, medial malleolus, bimalleolar, trimalleolar, and proximal fibula) will be included in this study.
healthy enough for orthopedic surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 - 12 months following surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 have a broken ankle of any type.
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I am fit for orthopedic surgery.
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I am scheduled for ankle fracture surgery at UAB.
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I am over 18 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle Fracture Healing
Secondary outcome measures
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
1,573 Previous Clinical Trials
2,272,777 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size for this medical research?

"Yes, according to clinicaltrials.gov this research initiative is still active as of February 25th 2022 and was first announced on June 12 2019. To date they are in the process of recruiting up to 500 individuals from a single medical centre."

Answered by AI

Is this initiative the inaugural effort of its kind?

"Since its initial trial in 2005, Aspirin has been heavily researched and received Phase 4 drug approval. Currently, 167 studies are underway across the world with participants from 1398 cities within 57 nations."

Answered by AI

Are there specific criteria for participants to qualify for this medical research?

"This clinical trial requires 500 people aged 18 and up, who have recently sustained an ankle fracture and are due to receive surgical repair at UAB."

Answered by AI

In what conditions is Aspirin utilized most frequently?

"Aspirin is the preferred means of managing percutaneous coronary intervention (PCI) and has been found to help with other afflictions such as dental procedures, inflammation, and neck pain."

Answered by AI

Is this medical experiment open to individuals younger than 40 years of age?

"The requirements to join this medical trial dictate that participants must be between 18 and 110 years old. In addition, 81 trials are designated for individuals who are under the age of majority while 450 studies accommodate seniors over 65."

Answered by AI
~68 spots leftby Jan 2025