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NCT01789216 · ClinicalTrials.gov registry record · Phase 3
Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)
A Phase 3 study of Orthopaedic Fractures, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 17
- Study locations
NCT01789216: Completed Phase 3 study of Orthopaedic Fractures, sponsored by Major Extremity Trauma Research Consortium.
NCT01789216 is a Phase 3 study of Orthopaedic Fractures that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01789216, a Phase 3 study of Orthopaedic Fractures, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial. Also, as a significant proportion of this population develops chronic post traumatic osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence of chronic pain and PTOA in this population.
Primary Outcome
Morphine equivalent opioid utilization during initial hospitalization through 48 hours following definitive fixation.
Conditions Studied
Interventions
- DRUG placebo
- DRUG NSAID
- DRUG Gabapentinoids
Study Locations (17)
Florida
- University of Miami Ryder Trauma Center - Miami
- St. Mary's Medical Center - West Palm Beach
Maryland
- Johns Hopkins University - Baltimore
- University of Maryland, R Adams Cowley Shock Trauma Center - Baltimore
Pennsylvania
- Penn State University M.S. Hershey Medical Center - Hershey
- University of Pittsburgh - Pittsburgh
Texas
- University of Texas Southwestern Medical Center - Dallas
- UT Health: The University of Texas Health Science Center at Houston Medical School - Houston
Indiana
- Eskenazi Health - Indianapolis
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Louisiana
- Louisiana State University Health Sciences Center - Shreveport
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 3 |
What the finished NCT01789216 record still lists
NCT01789216 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Orthopaedic Fractures appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT01789216 lists 17 locations in 13 states (Florida, Maryland, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01789216 about?
NCT01789216 is a clinical study titled "Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)". The purpose of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial. Also, as a significant proportion of this population develops chronic post traumati...
What is the current status of trial NCT01789216?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2013-07. Estimated completion is 2018-12-31.
What conditions does trial NCT01789216 study?
This clinical trial studies the following conditions: Orthopaedic Fractures.
What interventions are being tested in trial NCT01789216?
The interventions under investigation include: placebo (DRUG), NSAID (DRUG), Gabapentinoids (DRUG).
Who is sponsoring clinical trial NCT01789216?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01789216 being conducted?
This trial has 17 study locations across Florida, Indiana, Iowa, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01789216's enrollment target sits among peer trials
450 837th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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