Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures (NCT05000281) | Clinical Trial Compass
UnknownPhase 3
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures
United States1,000 participantsStarted 2021-09-14
Plain-language summary
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
* Patients 18-80 years old inclusive.
* Patients able to be followed at a Major Extremity Trauma \& Rehabilitation (METRC) facility for at least 12 months following injury
Exclusion Criteria:
* Patient unable to provide informed consent
* Patients who are current - intravenous drug user.
* Patients with a history of allergy to the study drugs.
* Patients unable to swallow oral medications or without functioning GI tract.
* Patients with a history of gastrointestinal bleeds or gastric perforation.
* Patients with a history of stroke or heart attack.
* Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
* Patients with any bleeding disorders.
* Patients with severe renal failure \[glomerular filtration rate (GFR):\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose.
* Patients undergoing daily treatment with systemic glucocorticoids before surgery.
* Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
* Patients with a Glasgow Coma Scale (GCS) \<15 at discharge.
* Patients with a closed head injury that precludes NSAIDS.
* Patients who are pregnant or lactati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numbers of participants with nonunion (secondary surgery to promote union)
Timeframe: Between 3 months and 12 months after definitive fixation surgery