VEGA System® Study in the Total Knee Arthroplasty

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

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

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Device: total knee prothesis VEGA System

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Remy Nizard; Phone Number: +33 1 49 95 65 65; Email: remy.nizard@lrb.aphp.fr

Study Locations

• France
  • Arras, France, 62012
    • Recruiting
    • Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie
    • Contact: Bruno Tillie; Phone Number: +33 3 21 60 22 11
  • Paris, France, 75 010
    • Not yet recruiting
    • Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie
    • Contact: Remy Nizard; Phone Number: +33 1 49 95 65 65

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Person for whom a replacement of knee was planed and for whom the surgeon planed to use VEGA System for the Knee Arthroplasty

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: BBraun Medical SAS

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AAG-O-H-1511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No