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NCT04028414 · ClinicalTrials.gov registry record · NA

Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures

A NA study of Rehabilitation, sponsored by Major Extremity Trauma Research Consortium.

Active
Registry status
NA
Development phase
450
Enrollment target
17
Study locations

NCT04028414: Active NA study of Rehabilitation, sponsored by Major Extremity Trauma Research Consortium.

NCT04028414 is a NA study of Rehabilitation that is active but no longer recruiting, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 450 participants, above the 135-participant average among 15 other Rehabilitation trials with a reported enrollment target (233% higher). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04028414, a NA study of Rehabilitation, is active but no longer recruiting, sponsored by Major Extremity Trauma Research Consortium.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
450 participants
Enrollment target
17
Study locations

Study Summary

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Primary Outcome

Re-admissions for a limb related issue and all re-operations on the study limb will be prospectively tracked by the Research Coordinators by routinely scanning hospital admission and orthopaedic surgery logs to identify all admissions and same day surgeries of patients actively enrolled in the study. Complications include loss of reduction and hardware failure, infection, non-union, malunion and fusion.

Conditions Studied

Interventions

  • OTHER Early Weight Bearing

Study Locations (17)

Maryland

  • University of Maryland R Adams Cowley Shock Trauma Center - Baltimore
  • Walter Reed National Military Medical Center - Bethesda

North Carolina

  • Carolinas Medical Center - Charlotte
  • Wake Forest Baptist Medical Center - Winston-Salem

Virginia

  • University of Virginia - Charlottesville
  • Inova Fairfax Hospital - Falls Church

Alabama

  • University of Alabama at Birmingham - Birmingham

California

  • University of California San Francisco Medical Center - San Francisco

Indiana

  • Methodist Hospital - Indianapolis

Minnesota

  • Hennepin County Medical Center / Regions Hospita - Minneapolis

New Hampshire

  • Dartmouth-Hitchcock Medical Center - Lebanon

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2020-01-01
Est. Completion 2025-03
Phase NA

What the registry record for NCT04028414 still lists

NCT04028414 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, above the 135-participant average among 15 other Rehabilitation trials with a reported enrollment target (233% higher).

The record links to 1 condition, with Rehabilitation appearing as the primary indexed condition, and to 1 intervention - of which Early Weight Bearing is the first listed.

NCT04028414 lists 17 locations in 14 states (Maryland, North Carolina, Virginia).

Frequently Asked Questions

What is clinical trial NCT04028414 about?

NCT04028414 is a clinical study titled "Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures". The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do...

What is the current status of trial NCT04028414?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2020-01-01. Estimated completion is 2025-03.

What conditions does trial NCT04028414 study?

This clinical trial studies the following conditions: Rehabilitation.

What interventions are being tested in trial NCT04028414?

The interventions under investigation include: Early Weight Bearing (OTHER).

Who is sponsoring clinical trial NCT04028414?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04028414 being conducted?

This trial has 17 study locations across Alabama, California, Indiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Rehabilitation

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 NCT04028414's enrollment target sits among peer trials

450 2nd of 15 the highest of 15 other Rehabilitation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Rehabilitation 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 NCT04028414, the US trial registry maintained by the National Library of Medicine. NCT04028414 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.