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The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.
Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zirconium Femoral Component | Experimental | Oxidized zirconium femoral component of Genesis II TKR system is used. |
|
| Cobalt Chrome | Active Comparator | Cobalt-Chromium Femoral component of Genesis II system is used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zirconium (Zirconium Genesis II) | Device | Oxidized Zirconium femoral component of Genesis II TKR system is used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Knee Society Knee Score | change in knee score will be compared with initial score, until mean follow up of 20 years. | Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the range of motion | change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years. | Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang-Won Park, MD | Ewha Womans University Mokdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Mokdong Hosptial | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15534531 | Background | Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13. | |
| 14652400 | Background | Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Cobalt-Chrome (Cobalt Chrome Genesis II) | Device | Cobalt Chrome Femoral Component of Genesis II TKR system is used |
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