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NCT04738318 · ClinicalTrials.gov registry record · Phase 4

Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)

A Phase 4 study, sponsored by Vanderbilt University Medical Center.

Terminated
Registry status
Phase 4
Development phase
3
Enrollment target

NCT04738318: Clinical Trial Phase 4 study, sponsored by Vanderbilt University Medical Center.

NCT04738318 is a Phase 4 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04738318, a Phase 4 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.

TERMINATED
Registry status
Phase 4
Development phase
3 participants
Enrollment target

Study Summary

The primary purpose of this study is to determine if perioperative glucocorticoid administration (IV intra-operative followed by a post-operative oral taper course) improves post-operative range of motion in a patient population that has sustained an intra-articular elbow fracture(s) (radial head, proximal ulna, distal humerus, or combined) that required operative fixation.

Primary Outcome

Flexion, extension, pronation, supination

Interventions

  • DRUG Saline
  • DRUG Glucocorticoids

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2022-06-16
Est. Completion 2023-03-10
Phase Phase 4

Why NCT04738318 stopped before completion

NCT04738318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.

NCT04738318 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04738318 about?

NCT04738318 is a clinical study titled "Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)". The primary purpose of this study is to determine if perioperative glucocorticoid administration (IV intra-operative followed by a post-operative oral taper course) improves post-operative range of motion in a patient population that has sustained an intra-articular elbow fracture(s) (radial head, p...

What is the current status of trial NCT04738318?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2022-06-16. Estimated completion is 2023-03-10.

What interventions are being tested in trial NCT04738318?

The interventions under investigation include: Saline (DRUG), Glucocorticoids (DRUG).

Who is sponsoring clinical trial NCT04738318?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04738318's enrollment target sits among peer trials

3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT04738318, the US trial registry maintained by the National Library of Medicine. NCT04738318 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.