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NCT04786119 · ClinicalTrials.gov registry record · NA
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures
A NA study, sponsored by Smith & Nephew.
- Completed
- Registry status
- NA
- Development phase
- 126
- Enrollment target
NCT04786119: Completed NA study, sponsored by Smith & Nephew.
NCT04786119 is a NA study that has completed, run by Smith & Nephew. The registered enrollment target is 126 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04786119, a NA study, has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
Study Summary
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications. Objectives: The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned. Research participants / locations: Research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India).
Primary Outcome
The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
Interventions
- DEVICE CORI Robotics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2021-02-17 |
| Est. Completion | 2024-09-10 |
| Phase | NA |
What the finished NCT04786119 record still lists
NCT04786119 is an interventional study that assigns participants to a tested intervention. The registered 126 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 (91% lower).
The record links to 0 conditions, and to 1 intervention - of which CORI Robotics is the first listed.
NCT04786119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04786119 about?
NCT04786119 is a clinical study titled "Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures". Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondyla...
What is the current status of trial NCT04786119?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2021-02-17. Estimated completion is 2024-09-10.
What interventions are being tested in trial NCT04786119?
The interventions under investigation include: CORI Robotics (DEVICE).
Who is sponsoring clinical trial NCT04786119?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04786119's enrollment target sits among peer trials
126 749th of 2000 higher than 1,248 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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