NCT07006675 Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
| NCT ID | NCT07006675 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Major Extremity Trauma Research Consortium |
| Condition | Tibial Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-05-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2021-05-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail. 2. Patients 18-80 years old inclusive. 3. Patients able to be followed at a METRC facility for at least 12 months following injury Exclusion Criteria: 1. Patient unable to provide informed consent 2. Patients who are current - intravenous drug user. 3. Patients with a history of allergy to the study drugs. 4. Patients unable to swallow oral medications or without functioning GI tract. 5. Patients with a history of gastrointestinal bleeds or gastric perforation. 6. Patients with a history of stroke or heart attack. 7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg. 8. Patients with any bleeding disorders. 9. Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\]. 10. Patients undergoing daily treatment with systemic glucocorticoids before surgery. 11. 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. 12. Patients with a GCS \<15 at discharge. 13. Patients with a closed head injury that precludes NSAIDS. 14. Patients who are pregnant or lactating at time of screening 15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.
Contact & Investigator
Thomas Higgins, MD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT07006675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tibial Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07006675 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT07006675 currently recruiting?
Yes, NCT07006675 is actively recruiting participants. Contact the research team at thomas.higgins@hsc.utah.edu for enrollment information.
Where is the NCT07006675 trial being conducted?
This trial is being conducted at Indianapolis, United States, Indianapolis, United States, Baltimore, United States, Cambridge, United States and 10 additional locations.
Who is sponsoring the NCT07006675 clinical trial?
NCT07006675 is sponsored by Major Extremity Trauma Research Consortium. The principal investigator is Thomas Higgins, MD at University of Utah. The trial plans to enroll 1,000 participants.