Postoperative Aspirin and Ankle Fracture Healing
Effects of Postoperative Aspirin on Ankle Fracture Healing
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2019
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2019
CompletedJanuary 13, 2025
January 1, 2025
6 months
November 8, 2018
January 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Ankle Fracture Healing
Union Rates of Ankle Fractures postoperatively as assessed clinically and radiographically. X-rays will be taken at each postoperative visit.
0 - 12 months following surgery
Secondary Outcomes (2)
Functional Outcomes
0 - 12 months following surgery
Visual Analog Scale for Pain
0 - 12 months following surgery
Study Arms (2)
Aspirin
EXPERIMENTAL250 patients will be randomized to receive Aspirin postoperatively.
Non-Aspirin
NO INTERVENTION250 patients will be randomized to not receive Aspirin postoperatively.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB Highland Hospital
Birmingham, Alabama, 35205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Associate Professor
Study Record Dates
First Submitted
November 8, 2018
First Posted
December 5, 2018
Study Start
June 12, 2019
Primary Completion
November 26, 2019
Study Completion
November 26, 2019
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share