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NCT04730271 · ClinicalTrials.gov registry record · NA
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
A NA study, sponsored by DePuy Orthopaedics.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT04730271: Completed NA study, sponsored by DePuy Orthopaedics.
NCT04730271 is a NA study that has completed, run by DePuy Orthopaedics. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04730271, a NA study, has completed, sponsored by DePuy Orthopaedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.
Primary Outcome
The primary objective of this clinical investigation is to evaluate whether the accuracy to plan of the long leg alignment achieved with VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome.
Interventions
- DEVICE Total Knee Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2023-09-06 |
| Phase | NA |
What the finished NCT04730271 record still lists
NCT04730271 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Total Knee Replacement is the first listed.
NCT04730271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04730271 about?
NCT04730271 is a clinical study titled "Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty". The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan ...
What is the current status of trial NCT04730271?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2021-02-23. Estimated completion is 2023-09-06.
What interventions are being tested in trial NCT04730271?
The interventions under investigation include: Total Knee Replacement (DEVICE).
Who is sponsoring clinical trial NCT04730271?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04730271's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 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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