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

Aesculap

Status: Completed

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

Treatments: Device: Navigated Revision Total Knee Arthroplasty; Device: Manual Revision Total Knee Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05113303

AAG-O-H-2012

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient underwent navigated revision surgery using the Columbus® Revision knee prosthesis (case group)
• Patient underwent conventional manual revision surgery using another implant system (control group)
• Written informed consent

Exclusion criteria

• Pregnancy
• Patient Age at time of revision surgery < 18 years
• Allergy to any prosthesis component

Trial design

100 participants in 2 patient groups

navigation assisted knee revision surgery

Treatment:

Device: Navigated Revision Total Knee Arthroplasty

manual procedure

Treatment:

Device: Manual Revision Total Knee Arthroplasty