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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 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. The trial reports 17 study locations across 13 states.

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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.

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

FieldValue
Enrollment Target 450 participants
Start Date 2013-07
Est. Completion 2018-12-31
Phase Phase 3

What the Registry Record Tells You About NCT01789216

The ClinicalTrials.gov registry entry for NCT01789216 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 450 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 30 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 13 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.