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NCT01140815 · ClinicalTrials.gov registry record · Phase 4

Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System

A Phase 4 study, sponsored by Anderson Orthopaedic Research Institute.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target

NCT01140815: Completed Phase 4 study, sponsored by Anderson Orthopaedic Research Institute.

NCT01140815 is a Phase 4 study that has completed, run by Anderson Orthopaedic Research Institute. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01140815, a Phase 4 study, has completed, sponsored by Anderson Orthopaedic Research Institute.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target

Study Summary

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.

Primary Outcome

Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.

Interventions

  • DEVICE Total Knee Replacement
  • DEVICE Deuce

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2007-09
Est. Completion 2013-05
Phase Phase 4

What the finished NCT01140815 record still lists

NCT01140815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

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

NCT01140815 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01140815 about?

NCT01140815 is a clinical study titled "Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System". The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmenta...

What is the current status of trial NCT01140815?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2007-09. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01140815?

The interventions under investigation include: Total Knee Replacement (DEVICE), Deuce (DEVICE).

Who is sponsoring clinical trial NCT01140815?

This trial is sponsored by Anderson Orthopaedic Research Institute, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01140815's enrollment target sits among peer trials

50 1255th of 2000 higher than 678 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 NCT01140815, the US trial registry maintained by the National Library of Medicine. NCT01140815 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.