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an other study will start with new outcome measures
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented TKA | Active Comparator |
| |
| Uncemented TKA | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical total knee replacement using cemented components | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe NEYRET, Pr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix-Rousse | Lyon | 69004 | France |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Surgical total knee replacement using uncemented components | Device | 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. |
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