VEGA Prospective Kiel

Completed

• Conditions: Rheumatoid Arthritis; Degenerative Osteoarthritis
• Interventions: Device: VEGA Knee

• Registration Number: NCT02802085
• Lead Sponsor: Aesculap AG

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-16
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee Arthroplasty	VEGA Knee	Vega Knee Arthroplasty

Primary Outcome Measures

Name	Time	Method
Revision (non-survival) rate	5 years	The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.

Secondary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS)	5 years	Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment
Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)	5 years	Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment
Pain	5 years	Changes of anterior knee pain according to the Waters and Bentley rating system from the preoperative baseline to the 5 year postoperative assessment
Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)	5 years	Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment
Knee Score (KS) of Knee Society Score (KSS)	5 years	The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment
Functional Score (FS) of Knee Society Score (KSS)	5 years	The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment

Trial Locations

Locations (1)

MEDBALTIC GmbH c/o Mare Klinikum; 🇩🇪 Kiel, Germany