All Polyethylene Tibia-VEGA Kiel — APT-VEGA_KI  

Rheumatoid Arthritis Clinical Trial

Official title: Prospective Observational 5 Year Follow-up on a Consecutive Cohort of 70 Primary Total Knee Arthroplasty (TKA) Cases Treated With All-polyethylene Tibia (APT) Components of the Posterior-stabilized VEGA System PS

Status Completed

Clinical Trial Summary

Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b).

Clinical Trial Description

This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® APT VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation. ;

Related Conditions & MeSH terms

• Deformity of Knee Joint
• Degenerative Osteoarthritis
• Osteoarthritis
• Other Instability, Knee
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis
• Stiffness of Knee, Not Elsewhere Classified

• NCT number: NCT02756702
• Study type: Observational
• Source: Aesculap AG
• Status: Completed
• Start date: March 2016
• Completion date: October 6, 2022