VEGA System® Study in the Total Knee Arthroplasty

Knee Arthroplasty Clinical Trial

Official title:

Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944409
• Other study ID #: AAG-O-H-1511
• Status: Recruiting
• Start date: July 1, 2016
• Est. completion date: February 2025

Study information

• Verified date: April 2019
• Source: BBraun Medical SAS
• Contact: Remy Nizard
• Phone: 1 49 95 65 65
• Email: remy.nizard[@]lrb.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Device:
• total knee prothesis VEGA System
total knee replacement

Locations

Country	Name	City	State
France	Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie	Arras
France	Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of the prosthesis at 5 years	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	needs of revision of at least one of the prosthesis component evaluated 5 years after the knee arthroplasty