Aspirin for Ankle Fracture Healing
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether taking aspirin after ankle surgery affects the healing process. Aspirin is often avoided for broken bones due to concerns it might slow healing, yet many people take it regularly for other health reasons. Participants will be divided into two groups: one will take aspirin after surgery, and the other will not. This trial suits those undergoing ankle surgery at UAB who are not already on aspirin or blood thinners. As an Early Phase 1 trial, this research aims to understand how aspirin affects healing, offering participants a chance to contribute to groundbreaking insights.
Do I need to stop taking my current medications for the trial?
The trial requires that you do not take aspirin or blood-thinning medications before starting. If you are currently taking these, you would need to stop before participating.
Is there any evidence suggesting that aspirin is likely to be safe for humans?
Research has shown that taking aspirin after ankle surgery does not slow bone healing. One study found that people who took aspirin healed as quickly as those who did not.
Another study examined whether aspirin increases the risk of bone fractures in older adults. It found that aspirin did not raise the risk of breaking bones such as the hip, wrist, or spine, indicating that aspirin is generally safe for bones.
Regarding side effects, the chance of developing blood clots (DVTs) was low and similar for both those who took aspirin and those who did not. This suggests that most people can tolerate aspirin well.
Overall, these findings suggest that aspirin is safe to use after ankle surgery in terms of bone healing and other risks.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using aspirin for ankle fracture healing because it could offer a simple and cost-effective alternative to traditional treatments like surgical fixation or immobilization. Unlike these common methods, aspirin works by reducing inflammation and potentially enhancing bone healing through its anti-inflammatory properties. This approach might not only speed up recovery but also minimize complications associated with more invasive treatments.
What evidence suggests that aspirin might be an effective treatment for ankle fracture healing?
This trial will compare the effects of taking aspirin versus not taking aspirin after ankle surgery. Research has shown that taking aspirin after ankle surgery does not slow bone healing. Studies found that people who took aspirin healed at about the same rate as those who did not. Specifically, one study showed that 95.9% of patients taking aspirin demonstrated bone healing at six weeks, compared to 98.6% of those not taking aspirin. These results suggest that aspirin doesn't significantly delay the healing process for ankle fractures. However, more research might still be needed to confirm these findings in different groups of people.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical repair of ankle fractures and are randomized to receive or not receive aspirin postoperatively
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
What Are the Treatments Tested in This Trial?
Interventions
- Aspirin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor