TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Osteoarthritis, Knee

Clinical Trial Details

NCT number	NCT04180423
Study type	Observational
Source	Restor3D
Contact
Status	Terminated
Phase
Start date	January 28, 2020
Completion date	September 19, 2022

View Details

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