Effects of Postoperative Aspirin on Ankle Fracture Healing

University of Alabama at Birmingham1 site in 1 country500 target enrollmentJune 12, 2019

ConditionsAnkle Fractures

InterventionsAspirin

DrugsAspirin

Overview

Phase: Early Phase 1
Intervention: Aspirin
Conditions: Ankle Fractures
Sponsor: University of Alabama at Birmingham
Enrollment: 500
Locations: 1
Primary Endpoint: Ankle Fracture Healing
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

Despite any new clinical research on aspirin's effects on fracture healing, it is now being used more commonly in the setting of fracture due to its effectiveness as a means of VTE prophylaxis following major orthopedic surgery.5 Additionally, aspirin offers the benefit of acting as an analgesic and many patients are prescribed aspirin in the long-term management of various health conditions. With all of the potential therapeutic benefits of aspirin, it is worth understanding whether prescribing this medication following operative fracture repair may impose a risk of delayed fracture healing. Patients undergoing surgical repair of ankle fractures at UAB who are deemed healthy enough for orthopedic surgery will be enrolled. Patients with multiple traumatic injuries, patients taking any type of blood-thinner medication, and patients taking aspirin prior to the start of the study will be excluded. No other exclusions will be made based on prior health conditions. There will be a group of patients that receives no aspirin and a group that does receive aspirin. Approximately 250 patients will be randomly assigned to each group. Patients will be identified for potential enrollment based on their plan to undergo surgical repair of ankle fracture at UAB hospital during the IRB approval period. This study will follow patients following routine protocol for ankle fracture repair and follow-up. Patients will be randomized into a group that is prescribed aspirin (325 mg) post-operatively vs. not prescribed aspirin. Patients will be followed throughout their recovery process. Patients will be scheduled for follow-up appointments with the operating physician at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. Patients will be asked to give a pain score (scale 1-10) and complete an SF-12 functional outcomes survey at each follow-up appointment. In line with normal protocol following fracture repair, radiographs will also be taken at each follow-up appointment to monitor the progression of fracture healing.

Registry

clinicaltrials.gov

Start Date

June 12, 2019

End Date

November 26, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Ashish Shah

M.D., Associate Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

•Over 18 years of age
•healthy enough for orthopedic surgery
•slated to undergo surgical repair of ankle fracture at UAB
•able to give consent All ankle fractures (lateral malleolus, medial malleolus, bimalleolar, trimalleolar, and proximal fibula) will be included in this study.