NCT01542580

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 255 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

Detailed description

This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates: * Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing * Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing * Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe) The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship. The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates. Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis
• Post Traumatic Deformity
• Complications; Arthroplasty
• Deformity of Limb

Interventions

Type	Name	Description
DEVICE	Vanguard SSK 360 with PS Bearing	non-constrained tibial bearing
DEVICE	Vanguard SSK 360 with PSC bearing	constrained tibial bearing
DEVICE	Vanguard DA 360	Dual-articulation device, only cleared in EU
DEVICE	Vanguard 360 TiNbN Femur with PS bearing	non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
DEVICE	Vanguard 360 TiNbN Femur with PSC bearing	constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur

Timeline

• Start date: 2012-03-01
• Primary completion: 2031-12-01
• Completion: 2031-12-01
• First posted: 2012-03-02
• Last updated: 2025-11-25

Locations

12 sites across 8 countries: United States, Belgium, Denmark, France, Germany, Italy, Spain, United Kingdom