VEGA System® Study in the Total Knee Arthroplasty

B. Braun

Status: Enrolling

Conditions: Knee Arthroplasty

Treatments: Device: total knee prothesis VEGA System

Study type: Observational

Funder types: Industry

Identifiers

NCT02944409

AAG-O-H-1511

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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