Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Frictionless GmbH, Kiel | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Obligatory 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 will be used within their intended purpose and no additional invasive or other stressful examinations 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® APT 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 PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All-Poly | All-polyethylene tibia VEGA System® PS - A posterior stabilized total knee arthroplasty (TKA) system using solely all-polyethylene tibia components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All-Poly | Device | Implantation of the VEGA PS using all-polyethylene tibia components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision Rate | The objective of the study is to collect clinical midterm outcome information on the product under investigation when used in routine clinical practice. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complication/Adverse Event rate | Cumulative Number of Complications / Adverse Events of any reason over the period of follow-up | 5 years |
| KOOS (Knee Osteoarthritis Outcome Score) | Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5-year postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult patients
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 years |
| KSS (Knee Society Score) | Changes of the Knee Society Score (KSS) with its Knee and Functional Score (KS and FS) from the preoperative baseline to the 5-year postoperative assessment | 5 years |
| SF-12® Health Survey (SF-12) | Changes of the total SF-12® Health Survey (SF-12) components Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) from the preoperative baseline to the 5-year postoperative assessment | 5 years |
| Change of anterior knee pain over follow-up period | 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |