Postoperative Aspirin and Ankle Fracture Healing

NCT ID: NCT03765619

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2019-11-26

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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Aspirin

250 patients will be randomized to receive Aspirin postoperatively.

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

250 patients will be randomized to receive postoperative Aspirin.

Non-Aspirin

250 patients will be randomized to not receive Aspirin postoperatively.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aspirin

250 patients will be randomized to receive postoperative Aspirin.

Intervention Type: DRUG

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.

Exclusion Criteria

• Under 18 years of age
• inability to give consent
• Pilon fractures
• Multiple traumatic fractures
• Known history of aspirin allergy
• History of severe reaction to aspirin
• History of bleeding disorder
• Other clear contraindication to being prescribed aspirin
• Taking blood-thinning medications (heparin, apixaban, etc)
• Taking aspirin prior to the start of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ashish Shah

M.D., Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UAB Highland Hospital

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300002057

Identifier Type: -

Identifier Source: org_study_id