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COMPLETED Phase 3

Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)

NCT01789216 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01789216

The ClinicalTrials.gov registry entry for NCT01789216 describes a study currently listed as completed. 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 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 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 1 condition, with Orthopaedic Fractures appearing as the primary indexed condition, and to 3 interventions — of which placebo 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: NCT01789216 reports 17 study locations spanning 13 distinct geographic areas — top geographies include Florida, Maryland, Pennsylvania. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01789216?

The interventions under investigation include: placebo (DRUG), NSAID (DRUG), Gabapentinoids (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01789216?

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 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.

Related

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