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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotating Platform High-Flex Cruciate Substituting TKA | Other |
| |
| Rotating Platform Cruciate Substituting TKA | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotating Platform High-Flex Cruciate Substituting TKA | Device |
| ||
| Rotating Platform Cruciate Substituting TKA |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | Preoperative, 4-6 weeks |
| Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | 4-6 months |
| Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Flexion | Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs. | preoperative, 4-6 weeks |
| Radiographic Flexion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G Hamilton, MD | Anderson Orthopaedic Research Institute | Principal Investigator |
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Subject enrollment began August 2007 and ended April 2009, with a total of 142 patients enrolled at an orthopaedic clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotating Platform High-Flex Cruciate Substituting TKA | |
| FG001 | Rotating Platform Cruciate Substituting TKA |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotating Platform High-Flex Cruciate Substituting TKA | |
| BG001 | Rotating Platform Cruciate Substituting TKA | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | All subjects with available data at the preoperative and 4-6 week intervals. | Posted | Mean | Standard Deviation | degrees | Preoperative, 4-6 weeks |
|
|
1 year follow-up
Collected according to standard protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotating Platform High-Flex Cruciate Substituting TKA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations | Systematic Assessment | Infection/polyethylene exchange |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Hamilton | Anderson Orthopaedic Research Institute | 703-619-4411 | research@aori.org |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Device |
|
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
| 1 year |
| Knee Society Score (KSS) | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome. | 1 year |
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome. | 1 year |
| Physician Decision |
|
| Has not scheduled one-year visit yet |
|
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Radiographic Flexion | Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs. | All subjects with available data at the preoperative and 4-6 week intervals. | Posted | Mean | Standard Deviation | degrees | preoperative, 4-6 weeks |
|
|
|
| Secondary | Radiographic Flexion | Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs. | All subjects with available data at the 1-year interval. | Posted | Mean | Standard Deviation | degrees | 1 year |
|
|
|
| Secondary | Knee Society Score (KSS) | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome. | All subjects with available KSS data at the 1-year interval. | Posted | Mean | Standard Deviation | score | 1 year |
|
|
|
| Secondary | Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome. | All subjects with available Oxford Knee Score data at the 1-year interval. | Posted | Mean | Standard Deviation | score | 1 year |
|
|
|
| Primary | Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | All subjects with available data at the 4-6 month interval. | Posted | Mean | Standard Deviation | degrees | 4-6 months |
|
|
|
| Primary | Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | All subjects with available data at the 1-year interval. | Posted | Mean | Standard Deviation | degrees | 1 year |
|
|
|
| 7 |
| 71 |
| 9 |
| 71 |
| EG001 | Rotating Platform Cruciate Substituting TKA | 4 | 71 | 3 | 71 |
|
| stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | manipulation for stiffness |
|
| patellar fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Repair of patellar fracture due to a fall. |
|
| quadriceps tendon rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Extensor mechanism reconstruction from a quadriceps tendon rupture. |
|
| symptomatic patellar crepitus | Musculoskeletal and connective tissue disorders | Systematic Assessment | Arthroscopic nodule debridement for patellar crepitus |
|
| patellar crepitus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Any paper drafted by authors regarding project results should be sent to sponsor at least 30 days before being submitted for publication. An abstract should be sent to the sponsor at least 10 days before being submitted. The sponsor will inform the authors of any changes deemed necessary to preserve the confidentiality of proprietary information or to insure scientific accuracy.
| D012216 |
| Rheumatic Diseases |