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NCT03146819 · ClinicalTrials.gov registry record
A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf
A clinical trial, sponsored by Restor3D.
- Terminated
- Registry status
- 31
- Enrollment target
NCT03146819: Clinical Trial study, sponsored by Restor3D.
NCT03146819 is a clinical trial that was terminated before completion, run by Restor3D. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03146819 was terminated before completion, sponsored by Restor3D.
- TERMINATED
- Registry status
- 31 participants
- Enrollment target
Study Summary
This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.
Primary Outcome
Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants
Interventions
- DEVICE Off-the-Shelf Knee Replacement System
- DEVICE iTotal PS Knee Replacement System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2016-12-16 |
| Est. Completion | 2017-05-31 |
Why NCT03146819 stopped before completion
NCT03146819 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Off-the-Shelf Knee Replacement System is the first listed.
NCT03146819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03146819 about?
NCT03146819 is a clinical study titled "A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf". This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.
What is the current status of trial NCT03146819?
This trial is currently terminated. The enrollment target is 31 participants. The study started on 2016-12-16. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT03146819?
The interventions under investigation include: Off-the-Shelf Knee Replacement System (DEVICE), iTotal PS Knee Replacement System (DEVICE).
Who is sponsoring clinical trial NCT03146819?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
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