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| Name | Class |
|---|---|
| Frictionless GmbH | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Arthroplasty | Vega Knee Arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEGA Knee | Device | TKA |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Ludger Gerdesmeyer, Professor | orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEDBALTIC GmbH c/o Mare Klinikum | Kiel | 24119 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38739584 | Derived | Gerdesmeyer L, Glowalla C, Lasic I, Al Muderis M, Weuster M, Klueter T. The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study. PLoS One. 2024 May 13;19(5):e0302885. doi: 10.1371/journal.pone.0302885. eCollection 2024. |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D001172 | Arthritis, Rheumatoid |
| D000013 | Congenital Abnormalities |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |