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NCT04058743 · ClinicalTrials.gov registry record · NA

Nickel Sensitivity

A NA study, sponsored by Rush University Medical Center.

Terminated
Registry status
NA
Development phase
9
Enrollment target

NCT04058743: Clinical Trial NA study, sponsored by Rush University Medical Center.

NCT04058743 is a NA study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04058743, a NA study, was terminated before completion, sponsored by Rush University Medical Center.

TERMINATED
Registry status
NA
Development phase
9 participants
Enrollment target

Study Summary

The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants. The hypothesis is that patients with a self-reported nickel sensitivity will have similar patient reported outcome scores compared to those patients without reported nickel sensitivity. Therefor the anticipation is for there to be no differences in other clinical outcome measures or functional outcome scores between the two cohorts.

Primary Outcome

Change from pre operative to post operative Knee Society Scores at various time intervals. KSS is scored 0-100 with 100 being a perfectly functioning knee and is used as a gauge of success for a knee replacement.

Interventions

  • DEVICE TKA with nickel free components
  • DEVICE TKA with standard cobalt chromium components

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-09-27
Est. Completion 2024-12-21
Phase NA
Rush University Medical Center

320 total trials

Why NCT04058743 stopped before completion

NCT04058743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which TKA with nickel free components is the first listed.

NCT04058743 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04058743 about?

NCT04058743 is a clinical study titled "Nickel Sensitivity". The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants. The hypothesis is that patients with a self-reported nickel sensitivity will have ...

What is the current status of trial NCT04058743?

This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2019-09-27. Estimated completion is 2024-12-21.

What interventions are being tested in trial NCT04058743?

The interventions under investigation include: TKA with nickel free components (DEVICE), TKA with standard cobalt chromium components (DEVICE).

Who is sponsoring clinical trial NCT04058743?

This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04058743's enrollment target sits among peer trials

9 1975th of 2000 higher than 25 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT04058743, the US trial registry maintained by the National Library of Medicine. NCT04058743 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.