Recruiting
Phase 3

NSAIDs

Sponsor:

Major Extremity Trauma Research Consortium

Code:

NCT05000281

Conditions

Tibia Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Study Details

Brief summary:

The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).

Conditions

Tibia Fracture

Study ID

NCT05000281

Start date

Sep 14, 2021

Status verified date

Oct, 2021

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Major Extremity Trauma \& Rehabilitation (METRC) facility for at least 12 months following injury

Exclusion Criteria:

  • 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.
  • Patients with a history of gastrointestinal bleeds or gastric perforation.
  • Patients with a history of stroke or heart attack.
  • Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
  • Patients with any bleeding disorders.
  • Patients with severe renal failure \[glomerular filtration rate (GFR):<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose.
  • Patients undergoing daily treatment with systemic glucocorticoids before surgery.
  • 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.
  • Patients with a Glasgow Coma Scale (GCS) <15 at discharge.
  • Patients with a closed head injury that precludes NSAIDS.
  • Patients who are pregnant or lactating at time of screening
  • 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

experimental: NSAID

Standard of care pain medication regimen with NSAIDs.

no intervention: No NSAIDs

Standard of care pain medication regiment with no NSAIDs

Interventions

Ibuprofen

600 mg Ibuprofen 3 times a day for up to six weeks.

Primary outcome measure

  • Numbers of participants with nonunion (secondary surgery to promote union) [ Time Frame: Between 3 months and 12 months after definitive fixation surgery ]

Central Contacts and Locations

Central contacts

Tara Taylor Joseph, MPH

410-614-6081ttaylo56@jhu.edu

Trisha Chaffee

tchaffe2@jhmi.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 841112

Contacts

Zach Olsen, MD

zachary.olsen@hsc.utah.edu

Sofia Hill

sophia.hill@hsc.utah.edu

Principal Investigator:

Thomas Higgins, MD

More Information

Sponsor

Major Extremity Trauma Research Consortium

Last update posted

Oct 6, 2021

Last verified

Oct, 2021

Keywords

  • NSAID
  • Nonsteroidal Anti-Inflammatory Drug
  • Pain Interference
  • Persistent Pain
  • Pain Control
  • Opioid Utilization
  • Nonunion Surgery
  • Fracture Healing
  • Orthopaedic trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2021-10-06.