VEGA Prospective Kiel

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective Observational 5 Year Follow-up on a Historical Consecutive Cohort of 100 Primary Total Knee Arthroplasty (TKA) Cases Treated With the Posterior-stabilized VEGA System® PS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802085
• Other study ID #: AAG-I-H-1319
• Status: Completed
• Start date: May 2016
• Est. completion date: February 2018

Study information

• Verified date: January 2019
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Voluntary 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 have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are to be carried out (acc. to MPG §23b).

Description:

This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® 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 PS components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been and are to be carried out (acc. to MPG §23b). This voluntary NIS is part of the post-marketing surveillance for the product under investigation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has received primary TKA at the study site five to six years ago using the product under investigation because of the following severe knee joint conditions that could not be treated through other therapies:

• degenerative osteoarthritis,

• rheumatoid arthritis,

• posttraumatic arthritis,

• symptomatic knee instability, knee stiffness or deformation of the knee joint

• Age at the time of surgery = 18 years

• Patient signed informed consent

Exclusion Criteria:

• Age younger than 18 years at the time of surgery

• Any prior joint replacement at the index knee

• Patient did not sign informed consent

• All cases not listed under indications (according to IfU)

• All cases showing any contraindication (according to IfU)

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Degenerative Osteoarthritis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• VEGA Knee
TKA

Locations

Country	Name	City	State
Germany	MEDBALTIC GmbH c/o Mare Klinikum	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	Frictionless GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision (non-survival) rate	The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.	5 years
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment	5 years
Secondary	Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)	Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment	5 years
Secondary	Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)	Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment	5 years
Secondary	Pain	Changes of anterior knee pain according to the Waters and Bentley rating system from the preoperative baseline to the 5 year postoperative assessment	5 years
Secondary	Knee Score (KS) of Knee Society Score (KSS)	The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment	5 years
Secondary	Functional Score (FS) of Knee Society Score (KSS)	The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment	5 years