Actively Recruiting
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Led by Major Extremity Trauma Research Consortium · Updated on 2025-06-05
1000
Participants Needed
14
Research Sites
300 weeks
Total Duration
On this page
Sponsors
M
Major Extremity Trauma Research Consortium
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with open (Grade I, II, or IIIa) or closed tibia fractures treated with a nail
- Age between 18 and 80 years inclusive
- Able to be followed at a METRC facility for at least 12 months after injury
You will not qualify if you...
- Unable to provide informed consent
- Current intravenous drug user
- History of allergy to the study drugs
- Unable to swallow oral medications or have a functioning gastrointestinal tract
- History of gastrointestinal bleeding or gastric perforation
- History of stroke or heart attack
- Require aspirin or NSAID treatment other than low dose aspirin (81 mg)
- Have any bleeding disorders
- Severe renal failure (GFR less than 30); moderate renal failure (GFR 30-59) allowed with modified dose
- Daily treatment with systemic glucocorticoids before surgery
- Likely to have difficulty maintaining follow-up, including severe psychiatric conditions, living too far from hospital, incarceration, or unstable housing
- Glasgow Coma Scale less than 15 at discharge
- Closed head injury preventing NSAID use
- Pregnant or lactating at screening
- Planned future bone graft procedure at time of initial surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Indiana University-Methodist
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
Harvard Medical Center
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
5
Hennepin Health
Minneapolis, Minnesota, United States, 55487
Actively Recruiting
6
University of Mississippi
Jackson, Mississippi, United States, 39216
Actively Recruiting
7
The MetroHealth System
Cleveland, Ohio, United States, 44109
Actively Recruiting
8
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
9
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
University of Texas Health Science Center - Houston
Houston, Texas, United States, 77030
Actively Recruiting
11
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
12
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
13
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
14
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
Actively Recruiting
Research Team
T
Thomas Higgins, MD
CONTACT
K
Katherine Frey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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