Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

Study Overview
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Brief Summary
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The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA). Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA. The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative. The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.

Official Title
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Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Surgical total knee replacement using cemented components
* Device: Surgical total knee replacement using uncemented components


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee osteoarthritis Need for a total knee arthroplasty Exclusion Criteria: Age < 50 or > 80 Need for a different procedure than a TKA Preoperative knee flexion < 90° Need for a TKA associated with a combined femoral or tibial osteotomy Knee already operated except for arthroscopy Mediocre bone quality

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cemented TKA<br> | Device: Surgical total knee replacement using cemented components<br>* Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.<br>|
| Active Comparator: Uncemented TKA<br> | Device: Surgical total knee replacement using uncemented components<br>* Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKS 2011 Score measuring the clinical results of TKA | IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms | One year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in each arm with radiological loosening signs of the TKA components | At one year postoperative, each patient will go under standard radiological exam seeking for signs of loosening of the prosthetic components. The number of patients presenting radiological signs of loosening will be compared between both arms. | One year postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, IKS Score, cemented, uncemented