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NCT02186587 · ClinicalTrials.gov registry record · NA

iTotal Pilot Study of ConforMIS Custom Total Knee Implant

A NA study, sponsored by University of Missouri-Columbia.

Completed
Registry status
NA
Development phase
28
Enrollment target

NCT02186587: Completed NA study, sponsored by University of Missouri-Columbia.

NCT02186587 is a NA study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02186587, a NA study, has completed, sponsored by University of Missouri-Columbia.

COMPLETED
Registry status
NA
Development phase
28 participants
Enrollment target

Study Summary

To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant. Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).

Primary Outcome

Subjects will walk for 6 minutes and the distance covered will be measured in feet.

Interventions

  • DEVICE ConforMIS custom total knee

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2014-06
Est. Completion 2016-04
Phase NA
University of Missouri-Columbia

291 total trials

What the finished NCT02186587 record still lists

NCT02186587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which ConforMIS custom total knee is the first listed.

NCT02186587 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02186587 about?

NCT02186587 is a clinical study titled "iTotal Pilot Study of ConforMIS Custom Total Knee Implant". To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant. Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom ins...

What is the current status of trial NCT02186587?

This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2014-06. Estimated completion is 2016-04.

What interventions are being tested in trial NCT02186587?

The interventions under investigation include: ConforMIS custom total knee (DEVICE).

Who is sponsoring clinical trial NCT02186587?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02186587's enrollment target sits among peer trials

28 1704th of 2000 higher than 293 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 NCT02186587, the US trial registry maintained by the National Library of Medicine. NCT02186587 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.