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 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ankle Fractures||Drug: Aspirin||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Postoperative Aspirin on Ankle Fracture Healing|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||May 1, 2021|
250 patients will be randomized to receive Aspirin postoperatively.
250 patients will be randomized to receive postoperative Aspirin.
No Intervention: Non-Aspirin
250 patients will be randomized to not receive Aspirin postoperatively.
- 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.
- 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.
- 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.
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
|Contact: Aaradhana J Jha, M.D.||firstname.lastname@example.org|
|Contact: Melanese Leonard-Warren, BSN, MSN, RNemail@example.com|