VEGA System® Study in the Total Knee Arthroplasty

Recruiting

• Conditions: Knee Arthroplasty

• Registration Number: NCT02944409
• Lead Sponsor: BBraun Medical SAS

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie; 🇫🇷 Paris, France

Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie; 🇫🇷 Arras, France