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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented fixation | Other | Nexgen High-Flexion Knee Replacement System using Cemented Fixation |
|
| Cementless fixation | Other | Nexgen High-Flexion Knee Replacement System using Cementless Fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Flexion Knee Replacement System using Cemented Fixation | Device |
| ||
| High-Flexion Knee Replacement System using Cementless Fixation |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin B Fricka, MD | Anderson Orthopaedic Research Institute | Principal Investigator |
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| Device |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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