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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Radiographic analysis
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.
Time frame: 4 week
Radiographic analysis
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.
Time frame: 1 year
Radiographic analysis
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.
Time frame: 2 year
Radiographic analysis
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.
Time frame: 5 year
Radiographic analysis
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.
Time frame: 10 year
Radiographic analysis
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.
Time frame: 15 year
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Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: Date of surgery
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 4 week
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 4 month
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 1 year
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 2 year
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 5 year
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 10 year
Complications
The number and type of adverse events will be monitored to assess safety.
Time frame: 15 year
Radiographic analysis
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.
Time frame: 4 month
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Time frame: 4 week
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Time frame: 1 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Time frame: 2 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Time frame: 5 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Time frame: 10 year
Knee Society Score
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Time frame: 15 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Time frame: 4 week
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Time frame: 1 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Time frame: 2 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Time frame: 5 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Time frame: 10 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery.
Time frame: 15 year
Visual analog pain score
Pain score will be measured from a patient-assessed visual analog pain scale.
Time frame: 4 week
Visual analog pain score
Pain score will be measured from a patient-assessed visual analog pain scale.
Time frame: 4 month