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NCT04180423 · ClinicalTrials.gov registry record
TKA Operating Room Efficiency for TKA Using Customized Implant Techniques
A clinical trial, sponsored by Restor3D.
- Terminated
- Registry status
- 59
- Enrollment target
NCT04180423: Clinical Trial study, sponsored by Restor3D.
NCT04180423 is a clinical trial that was terminated before completion, run by Restor3D. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04180423 was terminated before completion, sponsored by Restor3D.
- TERMINATED
- Registry status
- 59 participants
- Enrollment target
Study Summary
This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.
Primary Outcome
Surgeon questionnaire to determine operating room efficiency from the 1st to the 50th iTotal implant performed and to determine any differences that might exist between operating room efficiency between the iTotal surgery and baseline metrics when performing OTS implant surgery
Interventions
- DEVICE Off-the-Shelf Implant Total Knee Replacement
- DEVICE Customized Implant Total Knee Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2022-09-19 |
Why NCT04180423 stopped before completion
NCT04180423 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Off-the-Shelf Implant Total Knee Replacement is the first listed.
NCT04180423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04180423 about?
NCT04180423 is a clinical study titled "TKA Operating Room Efficiency for TKA Using Customized Implant Techniques". This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To co...
What is the current status of trial NCT04180423?
This trial is currently terminated. The enrollment target is 59 participants. The study started on 2020-01-28. Estimated completion is 2022-09-19.
What interventions are being tested in trial NCT04180423?
The interventions under investigation include: Off-the-Shelf Implant Total Knee Replacement (DEVICE), Customized Implant Total Knee Replacement (DEVICE).
Who is sponsoring clinical trial NCT04180423?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
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