A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement

• Radiographic analysis [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
• Radiographic analysis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
• Radiographic analysis [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
• Radiographic analysis [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
• Radiographic analysis [ Time Frame: 10 year ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
• Radiographic analysis [ Time Frame: 15 year ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
• Complications [ Time Frame: Date of surgery ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 10 year ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Complications [ Time Frame: 15 year ] [ Designated as safety issue: Yes ]
  The number and type of adverse events will be monitored to assess safety.
• Radiographic analysis [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.

• Knee Society Score [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
• Knee Society Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
• Knee Society Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
• Knee Society Score [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
• Knee Society Score [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
• Knee Society Score [ Time Frame: 15 year ] [ Designated as safety issue: No ]
  A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
• Oxford Knee Score [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  A patient reported questionnaire for assessing the outcome of knee surgery.
• Oxford Knee Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  A patient reported questionnaire for assessing the outcome of knee surgery.
• Oxford Knee Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  A patient reported questionnaire for assessing the outcome of knee surgery.
• Oxford Knee Score [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  A patient reported questionnaire for assessing the outcome of knee surgery.
• Oxford Knee Score [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  A patient reported questionnaire for assessing the outcome of knee surgery.
• Oxford Knee Score [ Time Frame: 15 year ] [ Designated as safety issue: No ]
  A patient reported questionnaire for assessing the outcome of knee surgery.
• Visual analog pain score [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  Pain score will be measured from a patient-assessed visual analog pain scale.
• Visual analog pain score [ Time Frame: 4 month ] [ Designated as safety issue: No ]
  Pain score will be measured from a patient-assessed visual analog pain scale.

The purpose of this study is to compare the the Nexgen knee replacement system using cementless fixation with the same system using cemented fixation. At minimum 2-year follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and cemented fixation will demonstrate no differences in clinical outcome based on Oxford and Knee Society scores, patient-assessed visual analog pain, clinical complications, radiographic fixation and implant survivorship.

• Device: High-Flexion Knee Replacement System using Cemented Fixation
• Device: High-Flexion Knee Replacement System using Cementless Fixation

• Cemented fixation
  Nexgen High-Flexion Knee Replacement System using Cemented Fixation
  Intervention: Device: High-Flexion Knee Replacement System using Cemented Fixation
• Cementless fixation
  Nexgen High-Flexion Knee Replacement System using Cementless Fixation
  Intervention: Device: High-Flexion Knee Replacement System using Cementless Fixation

Inclusion Criteria:

• Primary diagnosis of osteoarthritis of the knee
• Patients undergoing primary total knee replacement

Exclusion Criteria:

• Age over 75 years old
• Prior unicondylar knee arthroplasty
• Grossly porotic bone or bone defects requiring bone grafting
• Bone cuts not sufficiently accurate for cementless fixation