NCT03664791

Vanguard Rocc Post Market Surveillance

Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

Detailed description

The Vanguard rotating platform knee prosthesis (Vanguard ROCC) was launched in March 2009. Therefore there is a need to show the safety and performance of the Vanguard ROCC at long term. A maximum of 10 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators.

Conditions

• Osteoarthritis, Knee
• Rheumatoid Arthritis
• Traumatic Arthritis
• Posttraumatic Deformity
• Varus Deformity
• Valgus Deformity
• Osteotomy
• Arthrodesis

Interventions

Type	Name	Description
PROCEDURE	Vanguard Rocc	Patient operated with the Vanguard Rocc knee prosthesis

Timeline

• Start date: 2009-10-23
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2018-09-11
• Last updated: 2024-04-10

Locations

9 sites across 4 countries: Belgium, Denmark, France, United Kingdom