Sponsor:
Major Extremity Trauma Research Consortium
Code:
NCT07006675
Conditions
Tibial Fractures
Pain
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Interventions
600 mg Ibuprofen
Brief summary:
Conditions
Tibial Fractures
Pain
Study ID
NCT07006675
Start date
May 26, 2021
Status verified date
May, 2025
Completion date
Mar, 2027
Anticipated
Primary completion date
Dec, 2026
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Enrollment
1000 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: Standard of Care Pain Management with NSAIDs
no intervention: Standard of Care Pain Management without NSAIDs
Interventions
600 mg Ibuprofen
Primary outcome measure
Central contacts
Katherine Frey, PhD
kparris1@jhu.eduLocations
Eskenazi Hospital
Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator:
Karl Shively, MD
Indiana University-Methodist
Recruiting
Indianapolis, Indiana, United States, 46202
Contacts
Lauren Hill, BS
hilllc@iu.eduPrincipal Investigator:
Brian Mullis, MD
University of Maryland R Adams Cowley Shock Trauma Center
Recruiting
Baltimore, Maryland, United States, 21201
Contacts
Yasmin Degani
ydegani@umoa.umm.eduPrincipal Investigator:
Robert O'Toole, MD
Harvard Medical Center
Recruiting
Cambridge, Massachusetts, United States, 02138
Principal Investigator:
Michael Weaver, MD
Hennepin Health
Recruiting
Minneapolis, Minnesota, United States, 55487
Contacts
Principal Investigator:
Andrew Schmidt, MD
University of Mississippi
Recruiting
Jackson, Mississippi, United States, 39216
Principal Investigator:
Patrick Bergin, MD
The MetroHealth System
Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator:
Nicholas Romeo, MD
Allegheny General Hospital
Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator:
Gregory Altman, MD
Vanderbilt Medical Center
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Karen Trochez
karen.m.trochez@vumc.orgPrincipal Investigator:
William Obremskey, MD
University of Texas Health Science Center - Houston
Recruiting
Houston, Texas, United States, 77030
Contacts
Sterling Boutte
Sterling.Boutte@uth.tmc.eduPrincipal Investigator:
Stephen Warner, MD
University of Utah
Recruiting
Salt Lake City, Utah, United States, 84108
Principal Investigator:
Thomas Higgins, MD
Inova Fairfax Hospital
Recruiting
Falls Church, Virginia, United States, 22042
Principal Investigator:
Greg Gaski, MD
University of Wisconsin
Recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator:
Chris Domes, MD
University of Calgary, Foothills Medical Centre
Recruiting
Calgary, Alberta, Canada
Contacts
Prim Schneider, MD
prism.schneider@gmail.comPrincipal Investigator:
Prism Schneider, MD
Sponsor
Major Extremity Trauma Research Consortium
Last update posted
Jun 5, 2025
Last verified
May, 2025
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2025-06-05.