• The primary efficacy parameter is the revision rate for total knee arthroplasty at 10 years post- surgery. [ Time Frame: 10 ] [ Designated as safety issue: No ]
  

• Active flexion, Passive flexion, Active extension, and Passive extension ROM at the 2, 5, 7 and 10-year visits. [ Time Frame: 10 ] [ Designated as safety issue: No ]
  
• KSS pain and motion scores at the 3 months, 2, 5, 7 and 10-year visit. [ Time Frame: 10 ] [ Designated as safety issue: Yes ]
  
• SF-12 scores at the 3 months, 2, 5, 7 and 10-year visit. [ Time Frame: 10 ] [ Designated as safety issue: No ]
  
• Radiographic success/failure at the 3 months, 2, 5, 7 and 10-year visits. [ Time Frame: 10 ] [ Designated as safety issue: Yes ]
  
• Radiographic failure is defined as a score of 10 or greater according to the Knee Society Rotenographic Scoring System, regardless of symptoms. [ Time Frame: 10 ] [ Designated as safety issue: Yes ]
  

This is a fixed-bearing knee intended for use in patients undergoing cemented total knee arthroplasty. The devices to be used are both FDA approved via 510k clearance.

A total of 572 cases (286 per group) will be entered. Each patient will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary endpoint will be the revision rate at ten years. The result for these will be analyzed using an unconditional test of equivalence between two independent binomials. Chi-square analysis will be used to compare the instance of mortality, revision surgery, deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection. Other outcome measures incorporated in the Knee Society Clinical rating scale will undergo appropriate generalized linear regression for the type of outcome involved. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled.