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NCT01117571 · ClinicalTrials.gov registry record

Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

A clinical trial, sponsored by Restor3D.

Terminated
Registry status
120
Enrollment target

NCT01117571: Clinical Trial study, sponsored by Restor3D.

NCT01117571 is a clinical trial that was terminated before completion, run by Restor3D. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01117571 was terminated before completion, sponsored by Restor3D.

TERMINATED
Registry status
120 participants
Enrollment target

Study Summary

Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.

Primary Outcome

to assess knee pain and function

Interventions

  • DEVICE iUni® Unicompartmental Knee Resurfacing Device

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2010-04
Est. Completion 2023-01-10
Restor3D

20 total trials

Why NCT01117571 stopped before completion

NCT01117571 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which iUni® Unicompartmental Knee Resurfacing Device is the first listed.

NCT01117571 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01117571 about?

NCT01117571 is a clinical study titled "Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant". Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with sing...

What is the current status of trial NCT01117571?

This trial is currently terminated. The enrollment target is 120 participants. The study started on 2010-04. Estimated completion is 2023-01-10.

What interventions are being tested in trial NCT01117571?

The interventions under investigation include: iUni® Unicompartmental Knee Resurfacing Device (DEVICE).

Who is sponsoring clinical trial NCT01117571?

This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01117571, the US trial registry maintained by the National Library of Medicine. NCT01117571 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.