NCT05509972

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

International, Prospective, Longterm Study Comparing the Clinical Outcome and In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Knee Arthritis
• Knee Osteoarthritis
• Primary Osteoarthritis of Knee Nos
• Secondary Osteoarthritis of Knee Nos
• Rheumatoid Arthritis of Knee
• Instability, Joint
• Osteonecrosis
• Deformity Knee

Interventions

Type	Name	Description
DEVICE	total knee prosthesis implantation	Total Knee Arthroplasty (TKA) represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or comparable conditions even in young patients compromised by knee pain and limitations of daily living

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-02-01
• Completion: 2024-08-30
• First posted: 2022-08-22
• Last updated: 2024-10-09

Locations

1 site across 1 country: Germany