NCT05113303

COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients

Comparative, Case Control, Mono-center PMCF Study on Manual and Navigated Revision Knee Patients After a Minimum Follow-Up of Two Years

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations or treatment measures. The treatment will be carried out exclusively according to medical standards. The study therefore only serves the purpose of observing this standard-compliant treatment and specifically documenting it scientifically.

Detailed description

The study's main purpose is the collection of clinical data on the safety and performance of the Columbus® Revision Knee endoprosthesis

Conditions

• Knee Osteoarthritis
• Bone; Deformity, Congenital
• Prosthesis Failure
• Prosthesis-Related Infections

Interventions

Type	Name	Description
DEVICE	Navigated Revision Total Knee Arthroplasty	Patients in the case group receive a Columbus® Revision knee prosthesis, implanted with computer assisted surgery
DEVICE	Manual Revision Total Knee Arthroplasty	Patients in the control group will correspond to a historical cohort of patients in which manual jig-assisted knee revision was done.

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-06-16
• Completion: 2024-03-24
• First posted: 2021-11-09
• Last updated: 2025-08-14

Locations

1 site across 1 country: Spain