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RECRUITING Phase 3

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

NCT07006675 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG 600 mg Ibuprofen

Study Locations (14)

Indiana

  • Eskenazi Hospital — Indianapolis
  • Indiana University-Methodist — Indianapolis

Maryland

  • University of Maryland R Adams Cowley Shock Trauma Center — Baltimore

Massachusetts

  • Harvard Medical Center — Cambridge

Minnesota

  • Hennepin Health — Minneapolis

Mississippi

  • University of Mississippi — Jackson

Ohio

  • The MetroHealth System — Cleveland

Pennsylvania

  • Allegheny General Hospital — Pittsburgh

Tennessee

  • Vanderbilt Medical Center — Nashville

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2021-05-26
Est. Completion 2027-03
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07006675

The ClinicalTrials.gov registry entry for NCT07006675 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention — of which 600 mg Ibuprofen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07006675 reports 14 study locations spanning 13 distinct geographic areas — top geographies include Indiana, Maryland, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07006675 about?

NCT07006675 is a clinical study titled "Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial". 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.

What is the current status of trial NCT07006675?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2021-05-26. Estimated completion is 2027-03.

What conditions does trial NCT07006675 study?

This clinical trial studies the following conditions: Pain, Tibial Fractures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07006675?

The interventions under investigation include: 600 mg Ibuprofen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07006675?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07006675 being conducted?

This trial has 14 study locations across Indiana, Maryland, Massachusetts, Minnesota, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial