Postoperative Aspirin and Ankle Fracture Healing
Primary Purpose
Ankle Fractures
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Ankle Fractures
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
Sites / Locations
- UAB Highland HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aspirin
Non-Aspirin
Arm Description
250 patients will be randomized to receive Aspirin postoperatively.
250 patients will be randomized to not receive Aspirin postoperatively.
Outcomes
Primary Outcome Measures
Ankle Fracture Healing
Union Rates of Ankle Fractures postoperatively as assessed clinically and radiographically. X-rays will be taken at each postoperative visit.
Secondary Outcome Measures
Functional Outcomes
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.
Visual Analog Scale for Pain
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.
Full Information
NCT ID
NCT03765619
First Posted
November 8, 2018
Last Updated
February 14, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03765619
Brief Title
Postoperative Aspirin and Ankle Fracture Healing
Official Title
Effects of Postoperative Aspirin on Ankle Fracture Healing
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
250 patients will be randomized to receive Aspirin postoperatively.
Arm Title
Non-Aspirin
Arm Type
No Intervention
Arm Description
250 patients will be randomized to not receive Aspirin postoperatively.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
250 patients will be randomized to receive postoperative Aspirin.
Primary Outcome Measure Information:
Title
Ankle Fracture Healing
Description
Union Rates of Ankle Fractures postoperatively as assessed clinically and radiographically. X-rays will be taken at each postoperative visit.
Time Frame
0 - 12 months following surgery
Secondary Outcome Measure Information:
Title
Functional Outcomes
Description
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.
Time Frame
0 - 12 months following surgery
Title
Visual Analog Scale for Pain
Description
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.
Time Frame
0 - 12 months following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaradhana J Jha, M.D.
Phone
617-378-5116
Email
aaradhana.jha@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melanese Leonard-Warren, BSN, MSN, RN
Phone
205-975-2671
Email
mnleonard@uabmc.edu
Facility Information:
Facility Name
UAB Highland Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaradhana J. Jha, M.D.
Phone
617-378-5116
Email
aaradhana.jha@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashish B. Shah, M.D.
Email
ashishshah@uabmc.edu
12. IPD Sharing Statement
Learn more about this trial
Postoperative Aspirin and Ankle Fracture Healing
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