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NCT07006675 · ClinicalTrials.gov registry record · Phase 3
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
A Phase 3 study of Pain and Tibial Fractures, sponsored by Major Extremity Trauma Research Consortium.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 14
- Study locations
NCT07006675: Recruiting Phase 3 study of Pain and Tibial Fractures, sponsored by Major Extremity Trauma Research Consortium.
NCT07006675 is a Phase 3 study of Pain and Tibial Fractures that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 1,000 participants, above the 302-participant average among 374 other Pain trials with a reported enrollment target (231% higher). The trial reports 14 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07006675, a Phase 3 study of Pain and Tibial Fractures, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
Bone nonunion will be assessed by the presence of a secondary surgery to promote union after 3 months and up to 12 months post definitive fixation surgery. Non-prophylactic secondary surgery to promote union will be considered evidence of nonunion. Each case will be independently reviewed by members of the METRC Central Adjudication Committee and if at least 2 members agree with the assessment of secondary surgery to promote union, no further review will be necessary. The METRC Central Adjudicat
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
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
What NCT07006675 shows while recruiting
NCT07006675 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 302-participant average among 374 other Pain trials with a reported enrollment target (231% higher).
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.
NCT07006675 lists 14 locations in 13 states (Indiana, Maryland, Massachusetts).
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.
What interventions are being tested in trial NCT07006675?
The interventions under investigation include: 600 mg Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT07006675?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07006675's enrollment target sits among peer trials
1,000 13th of 374 higher than 360 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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