An observational study in Degenerative Osteoarthritis and Rheumatoid Arthritis, sponsored by Aesculap AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-23.
Sponsored by Aesculap AG · Observational
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).
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 84 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients
Exclusion Criteria:
Vega Knee Arthroplasty
Device: VEGA Knee
TKA
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.
Time frame: 5 years
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Aesculap AG