VEGA Prospective Kiel

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Degenerative Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Device: VEGA Knee


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee Arthroplasty<br>Vega Knee Arthroplasty | Device: VEGA Knee<br>* TKA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Knee Replacement, TKA, TKR, Stiffness of Knee, Deformity, Knee Joint, Instability, Post-traumatic, Arthrosis