500 Participants Needed

Aspirin for Ankle Fracture Healing

AJ
ML
Overseen ByMelanese Leonard-Warren, BSN, MSN, RN
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to identify if postoperative aspirin use leads to a delay in fracture healing. NSAIDs have long been avoided in the management of fractures, due to the belief that they may impair fracture healing. As aspirin is frequently prescribed for long-term management of various medical conditions, it is worth understanding if continuing to take aspirin during the process of fracture healing has a clinically significant effect on the rate of fracture healing.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

able to give consent
I have a broken ankle of any type.
I am fit for orthopedic surgery.
See 2 more

Exclusion Criteria

I have a history of bleeding disorders.
I have a broken shinbone near my ankle.
You have had a serious reaction to aspirin in the past.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical repair of ankle fractures and are randomized to receive or not receive aspirin postoperatively

Immediate postoperative period

Follow-up

Participants are monitored for fracture healing and functional outcomes with follow-up appointments at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

12 months
5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Aspirin
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: AspirinExperimental Treatment1 Intervention
Group II: Non-AspirinActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+
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