In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis (COLRAS)

Aesculap

Status: Terminated

Conditions: Knee Arthritis; Primary Osteoarthritis of Knee Nos; Deformity Knee; Osteonecrosis; Secondary Osteoarthritis of Knee Nos; Rheumatoid Arthritis of Knee; Instability, Joint; Knee Osteoarthritis

Treatments: Device: total knee prosthesis implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT05509972

AAG-O-H-2024

Details and patient eligibility

About

This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer coated so called "Advanced Surface" (AS) of the same implant. The clinical investigation is designed as a International, prospective, longterm non-interventional study in order to gain clinical data of many patients within the routine clinical application of the investigational device.

Enrollment: 7 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for a primary bicondylar total knee endoprosthesis with the Columbus® DD knee prosthesis
• Written signed informed consent of patient
• Willingness and mental ability to participate at the long-term follow-up examinations

Exclusion criteria

• Pregnancy
• Patient age <45 and >75years
• Acute inflammatory arthritis
• Coagulation disorders (e.g. Haemophilia)

Trial design

7 participants in 2 patient groups

Columbus® DD Primary CoCr

Description:

Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr)

Treatment:

Device: total knee prosthesis implantation

Columbus® DD Primary CoCr AS coated

Description:

Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr) Advanced Surface

Treatment:

Device: total knee prosthesis implantation