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Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

RecruitingPhase 3

Who can join

Ages 18 to 80 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Major Extremity Trauma Research Consortium · Participants: 1,000 · Started: May 26, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT07006675

Locations in the U.S.

IndianaEskenazi Hospital, Indianapolis
Indiana University-Methodist, Indianapolis
MarylandUniversity of Maryland R Adams Cowley Shock Trauma Center, Baltimore
MassachusettsHarvard Medical Center, Cambridge
MinnesotaHennepin Health, Minneapolis
MississippiUniversity of Mississippi, Jackson
OhioThe MetroHealth System, Cleveland
PennsylvaniaAllegheny General Hospital, Pittsburgh
TennesseeVanderbilt Medical Center, Nashville
TexasUniversity of Texas Health Science Center - Houston, Houston
UtahUniversity of Utah, Salt Lake City
VirginiaInova Fairfax Hospital, Falls Church
WisconsinUniversity of Wisconsin, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.