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New treatment option for Tibial Fractures
Official title Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07006675
What this study is testing
What is 600 mg Ibuprofen?
600 mg Ibuprofen is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for tibial fractures.
Also referred to as Advil, Motrin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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 METRC facility for at least 12 months following injury
You likely can't join if
- 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.
See the full eligibility 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 METRC facility for at least 12 months following injury
- 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 [GFR:\<30]. Patients with moderate renal failure [GFR: 30-59] may participate in the study at a modified dose [see section 8.6 for defined 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...
- Patients with a GCS \<15 at discharge.
- Patients with a closed head injury that precludes NSAIDS.
- Patients who are pregnant or lactating at time of screening
- Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Cambridge, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Jackson, Mississippi, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Falls Church, Virginia, United States
- Madison, Wisconsin, United States
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Baltimore, Maryland, United States; Cambridge, Massachusetts, United States; Minneapolis, Minnesota, United States; Jackson, Mississippi, United States; Cleveland, Ohio, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.