Aspirin for Ankle Fracture Healing

Overseen By Melanese Leonard-Warren, BSN, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Blood thinners, Aspirin

Disqualifiers: Pilon fractures, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: Immediate postoperative period

500 Participants Needed

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.

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.

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?

Group I: Aspirin Experimental Treatment 1 Intervention

250 patients will be randomized to receive Aspirin postoperatively.

Group II: Non-Aspirin Active Control 1 Intervention

250 patients will be randomized to not receive Aspirin postoperatively.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+