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| Name | Class |
|---|---|
| Stryker Trauma and Extremities | INDUSTRY |
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The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial Prosthesis Study will determine whether there is a significant difference in patient-reported and measured clinical outcomes (e.g. pain, function, length of recovery, and patient satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless group) and those treated with cemented tibial prosthesis (the cement group) over the first two postoperative years. Radiographs will be assessed before surgery and at established post-operative intervals to determine if there are any significant differences between patients in the two groups and to assess the influence of component fixation on radiographic stability over time. Complication and revision rates will also be assessed for comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented Tibia | Active Comparator | Assessing the clinical outcomes of the different type of fixation |
|
| Cementless Tibia | Active Comparator | Assessing the clinical outcomes of the different type of fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemented Tibia | Procedure | Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking |
|
| Measure | Description | Time Frame |
|---|---|---|
| To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique | 2014 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Clohisy, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Cementless Tibia | Procedure | Assessing the clinical outcomes of the different type of fixation |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |