NCT04076202

Clinical Evaluation of Vanguard DD RP

Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population

Detailed description

This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.

Conditions

• Knee Osteoarthritis
• Post-traumatic Osteoarthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Cementless Vanguard DD RP	Patients treated with the Cementless Vanguard DD RP knee implant

Timeline

• Start date: 2013-07-11
• Primary completion: 2018-08-26
• Completion: 2026-12-31
• First posted: 2019-09-03
• Last updated: 2024-05-17

Locations

1 site across 1 country: Austria