MEDBALTIC GmbH c/o Mare Klinikum
Kiel, 24119, Germany
NCT Number: NCT02802085
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).
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Notify Me18 year and older
All sexes
Observational
Kiel, 24119, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TKA
Time frame: 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.
Time frame: 5 years
Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment
Time frame: 5 years
Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment
Time frame: 5 years
Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment
Time frame: 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
Time frame: 5 years
The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment
Time frame: 5 years
The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment
Aesculap AG
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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