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The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. |
|
| 2 | Active Comparator | Study arm will consist of patients that are treated with the NexGen CR Knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NexGen CR-Flex Fixed Bearing Knee | Device | NexGen CR-Flex Fixed Bearing femoral component |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Range of Motion (ROM) | The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Return to Function (RtF) Via Knee Scoiety Score (Modified) | Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor. | 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dickinson Medical Group, LLC | Milford | Delaware | 19963 | United States | ||
| University of Chicago Hospital |
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Patients were enrolled between 2004 and 2008 at a total of 15 sites throughout the USA
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| ID | Title | Description |
|---|---|---|
| FG000 | CR Flex Fixed Bearing Knee | Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. |
| FG001 | CR Standard Knee | Study arm will consist of patients that are treated with the NexGen CR Knee. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CR Flex Fixed Bearing Knee | Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. |
| BG001 | CR Standard Knee | Study arm will consist of patients that are treated with the NexGen CR Knee. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Postoperative Range of Motion (ROM) | The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded. | There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48. | Posted | Mean | Standard Deviation | degrees | 24 Months |
|
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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 | CR Flex Fixed Bearing Knee | Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Death | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Knee Related Complication | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kacy Arnold, Associate Director, Clinical Affairs | Zimmer, Inc | 574-371-8336 | kacy.arnold@zimmer.com |
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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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| NexGen CR Knee | Device | NexGen Complete Knee Solution Cruciate Retaining femoral component |
|
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Rockford Orthopedic Associates | Rockford | Illinois | 61107 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
| Orthopaedic Associates of Grand Rapids, PC | Grand Rapids | Michigan | 49525 | United States |
| Pinehurst Surgical Center | Pinehurst | North Carolina | 28374 | United States |
| Slocum Orthopedics, PC | Eugene | Oregon | 97401 | United States |
| The Orthopedic Group | Clairton | Pennsylvania | 15025 | United States |
| Death |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Study arm will consist of patients that are treated with the NexGen CR Knee.
|
|
| Secondary | Return to Function (RtF) Via Knee Scoiety Score (Modified) | Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor. | There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully. | Posted | Mean | Standard Deviation | units on a scale | 24 Months |
|
|
|
| 1 |
| 87 |
| 2 |
| 87 |
| EG001 | CR Standard Knee | Study arm will consist of patients that are treated with the NexGen CR Knee. | 2 | 102 | 6 | 102 |
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Wound Dehiscence | Non-systematic Assessment |
|
| Articular Polyethylene Excessive Wear | Musculoskeletal and connective tissue disorders | Polyethylene Wear | Non-systematic Assessment |
|
| Stiff Knee Resulting in Manipulation | Musculoskeletal and connective tissue disorders |
|
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