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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: High-Flexion Knee Replacement System using Cemented Fixation
* Device: High-Flexion Knee Replacement System using Cementless Fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cemented fixation<br>Nexgen High-Flexion Knee Replacement System using Cemented Fixation | Device: High-Flexion Knee Replacement System using Cemented Fixation<br> <br> |
| Other: Cementless fixation<br>Nexgen High-Flexion Knee Replacement System using Cementless Fixation | Device: High-Flexion Knee Replacement System using Cementless Fixation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 15 year | 
| Complications | The number and type of adverse events will be monitored to assess safety. | Date of surgery | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 4 week | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 4 month | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 1 year | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 2 year | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 5 year | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 10 year | 
| Complications | The number and type of adverse events will be monitored to assess safety. | 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. | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. | 4 week | 
| Knee Society Score | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. | 1 year | 
| Knee Society Score | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. | 2 year | 
| Knee Society Score | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. | 5 year | 
| Knee Society Score | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. | 10 year | 
| Knee Society Score | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. | 15 year | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. | 4 week | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. | 1 year | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. | 2 year | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. | 5 year | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. | 10 year | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. | 15 year | 
| Visual analog pain score | Pain score will be measured from a patient-assessed visual analog pain scale. | 4 week | 
| Visual analog pain score | Pain score will be measured from a patient-assessed visual analog pain scale. | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, total knee replacement, cementless TKA, high flexion, trabecular metal