Recruiting
Phase 3

Standard Pain Management

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

Study Details

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.

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Pain Management with NSAIDs

Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.

no intervention: Standard of Care Pain Management without NSAIDs

Control patients will receive standard of care pain medication regimen and may not use NSAIDs. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs.

Interventions

600 mg Ibuprofen

Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.

Primary outcome measure

  • Secondary surgery to promote bone union after 3 months post initial surgery [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Katherine Frey, PhD

kparris1@jhu.edu

Locations

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.edu

Principal Investigator:

Brian Mullis, MD

University of Maryland R Adams Cowley Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal 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

Principal Investigator:

William Obremskey, MD

University of Texas Health Science Center - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal 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.com

Principal Investigator:

Prism Schneider, MD

More Information

Sponsor

Major Extremity Trauma Research Consortium

Last update posted

Jun 5, 2025

Last verified

May, 2025

Keywords

  • Ibuprofen
  • Pain Management
  • Tibia Fracture
  • IM Nail Fixation
  • NSAID

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.