NCT06203756

Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 713 (estimated)
• Sponsor: Corin · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow up.

Detailed description

This study has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision RA-TKA up to 10-year follow up. Prospective data will be collected for this Post Market Clinical Follow up (PMCF) study and the data will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment on annual basis and support presentations at orthopaedic congresses and/or peer-reviewed publication(s). Participants will be selected for recruitment into the study from the general population of participants requiring a primary or revision knee-arthroplasty and considered suitable to receive the Apex Knee System.

Conditions

• Arthroplasties, Knee Replacement
• Revision Arthroplasty

Interventions

Type	Name	Description
DEVICE	Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC	Robotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type
DEVICE	Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS	Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type
DEVICE	Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision	Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type

Timeline

• Start date: 2017-11-09
• Primary completion: 2029-01-01
• Completion: 2040-04-01
• First posted: 2024-01-12
• Last updated: 2025-05-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study