Clinical Trials Directory

Trials / Completed

CompletedNCT02756702

All Polyethylene Tibia-VEGA Kiel

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
Phase
—
Study type
Observational
Enrollment
70 (actual)
Sponsor
Aesculap AG · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEAll-PolyImplantation of the VEGA PS using all-polyethylene tibia components

Timeline

Start date
2016-03-01
Primary completion
2017-12-01
Completion
2022-10-06
First posted
2016-04-29
Last updated
2023-06-26

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02756702. Inclusion in this directory is not an endorsement.