Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Conditions

• Arthroplasties, Knee Replacement
• Revision Arthroplasty

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC — DEVICE
  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
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS — DEVICE
  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
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision — DEVICE
  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

Study Details

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.

Key Dates

Start date

Nov 9, 2017

Status verified

May 2025

Primary completion

Jan 1, 2029

Completion

Apr 1, 2040

Study Design

Enrollment

713 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Other: Revision Total Knee Arthroplasty
  Sensor-assisted robotic surgery cohort with a tibia first workflow. Revision Total Knee Arthroplasty components.
• Other: Primary Total Knee Arthroplasty
  Sensor-assisted robotic surgery cohort with a tibia first workflow. Primary Total Knee Arthroplasty

Primary Outcome Measure

Survivorship [ Time Frame: 10 Years ]

Locations (6)

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