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.
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.
Major Extremity Trauma Research Consortium
Lead sponsor
United States Department of Defense
Collaborator