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NCT01551472 · ClinicalTrials.gov registry record
Post Market Study of the 3DKnee™ With E-plus Insert
A clinical trial, sponsored by Encore Medical, L.P..
- Terminated
- Registry status
- 175
- Enrollment target
NCT01551472: Clinical Trial study, sponsored by Encore Medical, L.P..
NCT01551472 is a clinical trial that was terminated before completion, run by Encore Medical, L.P.. The registered enrollment target is 175 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01551472 was terminated before completion, sponsored by Encore Medical, L.P..
- TERMINATED
- Registry status
- 175 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.
Primary Outcome
The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture. Overall success will be defined as a KSS score ≥ 80 at two years. Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-de
Interventions
- DEVICE 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2012-04 |
| Est. Completion | 2022-01 |
Why NCT01551472 stopped before completion
NCT01551472 is an observational study that tracks outcomes without assigning an intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts is the first listed.
NCT01551472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01551472 about?
NCT01551472 is a clinical study titled "Post Market Study of the 3DKnee™ With E-plus Insert". The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.
What is the current status of trial NCT01551472?
This trial is currently terminated. The enrollment target is 175 participants. The study started on 2012-04. Estimated completion is 2022-01.
What interventions are being tested in trial NCT01551472?
The interventions under investigation include: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts (DEVICE).
Who is sponsoring clinical trial NCT01551472?
This trial is sponsored by Encore Medical, L.P., which has 16 total clinical trials registered on ClinicalTrials.gov.
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