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Postoperative Aspirin and Ankle Fracture Healing

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ClinicalTrials.gov Identifier: NCT03765619
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Ashish Shah, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ankle Fractures Drug: Aspirin Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Postoperative Aspirin on Ankle Fracture Healing
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Aspirin
250 patients will be randomized to receive Aspirin postoperatively.
 Drug: Aspirin
250 patients will be randomized to receive postoperative Aspirin.
No Intervention: Non-Aspirin
250 patients will be randomized to not receive Aspirin postoperatively.


Outcome Measures
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Primary Outcome Measures :
  1. Ankle Fracture Healing [ Time Frame: 0 - 12 months following surgery ]
    Union Rates of Ankle Fractures postoperatively as assessed clinically and radiographically. X-rays will be taken at each postoperative visit.


Secondary Outcome Measures :
  1. Functional Outcomes [ Time Frame: 0 - 12 months following surgery ]
    Patients will complete an Short Form-12 functional outcomes survey at each follow-up appointment, which is a health outcomes scale that includes assessment of general health, physical function, pain, social function, and mental health. Scores are combined to give Physical Health Composite Scores and Mental Health Composite Scores. Scale is 0 - 100, with lower scores indicating worse outcomes, and higher scores indicating better outcomes.

  2. Visual Analog Scale for Pain [ Time Frame: 0 - 12 months following surgery ]
    Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765619


Contacts
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Contact: Aaradhana J Jha, M.D. 617-378-5116 aaradhana.jha@gmail.com
Contact: Melanese Leonard-Warren, BSN, MSN, RN 205-975-2671 mnleonard@uabmc.edu

Locations
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United States, Alabama
UAB Highland Hospital Recruiting
Birmingham, Alabama, United States, 35205
Contact: Aaradhana J. Jha, M.D.    617-378-5116    aaradhana.jha@gmail.com   
Contact: Ashish B. Shah, M.D.       ashishshah@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
More Information
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Responsible Party: Ashish Shah, M.D., Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03765619    
Other Study ID Numbers: IRB-300002057
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics