A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

• AMERICAN KNEE SOCIETY KNEE SCORE [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
  Improvement of American Knee Society Knee Score between pre operative and 2 years post-operative follow up
  
  

• AMERICAN KNEE SOCIETY FUNCTION SCORE [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
  Improvement of American Knee Society Function Score between pre operative and 2 years post-operative follow up
  
  
• Device related complications [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
  Survivorship at 10 years post-operative follow up
  
  
• Radiographic evaluation [ Time Frame: 5 years postoperative ] [ Designated as safety issue: Yes ]
  Radiographic evaluation at 6 months, 1year, 2 years, 3 years and 5 years post-operative visit
  
  

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
• Mobile Bearing Knee - Vanguard DA360
• Hinged Knee - Vanguard BCH 360 (will not be investigated until this design is CE Marked) 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 safety of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured from pre-operatively to post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.

The data gathered would be collated and used to provide feedback to designing engineers; support marketing efforts, and answer potential questions from reimbursement agencies.

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.