Degenerative Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Total Knee Arthroplasty, Total Knee Replacement, TKA, TKR, Stiffness of Knee, Deformity, Knee Joint, Instability, Post-traumatic, Arthrosis
Brief summary
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
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.
Interventions
DEVICEVEGA Knee
TKA
Sponsors
Frictionless GmbH
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision (non-survival) rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12) | 5 years | Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment |
| Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12) | 5 years | Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 5 years | Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment |
| Knee Score (KS) of Knee Society Score (KSS) | 5 years | The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment |
| Functional Score (FS) of Knee Society Score (KSS) | 5 years | The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment |
| Pain | 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 |
Countries
Germany
Outcome results
None listed