Knee Arthroplasty
Conditions
Brief summary
This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components
Interventions
DEVICEtotal knee prothesis VEGA System
total knee replacement
Sponsors
BBraun Medical SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient from 18 to 75 years old 2. Patient is able to comply with follow-up requirements including postoperative self-evaluations. 3. Patient requires a primary knee replacement. 4. Patient has a diagnosis of osteoarthritis 5. Patient has intact collateral ligaments.
Exclusion criteria
1. Vulnerable patient under legal protection 2. Patients with inflammatory arthritis. 3. Patients that have had a high tibial osteotomy or femoral osteotomy. 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate of the prosthesis at 5 years | needs of revision of at least one of the prosthesis component evaluated 5 years after the knee arthroplasty | If a patient withdraws from the study for any reason, counts as the end date for the survival of the implant of the last day on which the implants were well known even in place |
Countries
France
Contacts
Primary ContactRemy Nizard
Outcome results
None listed