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The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.
This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative 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 LPS-Flex Fixed Bearing Knee. |
|
| 2 | Active Comparator | Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NexGen LPS-Flex Fixed Bearing Knee | Device | NexGen LPS-Flex Fixed Bearing femoral component |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Range of Motion (ROM) | Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension. | 6 Weeks to 2 Years Post-op, based on on the intervals listed |
| Measure | Description | Time Frame |
|---|---|---|
| Return to Function (RtF) Via Knee Society 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 established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor. | 6 Weeks to 2 Years Post-op, based on on the intervals listed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| VA Medical Center |
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Patients were enrolled between June 2001 and December 2007 at a total of 12 sites throughout the US/Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | LPS Flex Fixed Bearing Knee | Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee. |
| FG001 | LPS Standard Knee | Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| NexGen Legacy Posterior Stabilized Knee | Device | NexGen Legacy Posterior Stabilized femoral component |
|
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| Decatur |
| Georgia |
| 30033 |
| United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794 | United States |
| Joint Replacement Surgeons of Indiana | Indianapolis | Indiana | 46260 | United States |
| The Center for Hip and Knee Surgery | Mooresville | Indiana | 46158 | United States |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28209 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| VSAS Orthopaedics | Allentown | Pennsylvania | 18103 | United States |
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States |
| Piedmont Orthopaedic Associates | Greenville | South Carolina | 29615 | United States |
| Orthopaedic Specialists of Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Vanderbilt Orthopaedic Institute | Nashville | Tennessee | 37232 | United States |
| Rebecca Sealy Hospital | Galveston | Texas | 77555 | United States |
| The Rectors and Visitors of the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J1C5 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LPS Flex Fixed Bearing Knee | Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee. |
| BG001 | LPS Standard Knee | Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | An LPS Standard patient's demographic CRF is missing and therefore, the total numbers for this category will be off by one. | Number | participants |
| ||||||||||||||||||
| Age Continuous | An LPS Standard patient's demographic CRF is missing and therefore, the total numbers for this category will be off by one. | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | An LPS Standard patient's demographic CRF is missing and therefore, the total numbers for this category will be off by one. | Number | participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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) | Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension. | Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval. | Posted | Mean | Standard Deviation | degrees | 6 Weeks to 2 Years Post-op, based on on the intervals listed |
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| Secondary | Return to Function (RtF) Via Knee Society 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 established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor. | Posted | Mean | Standard Deviation | units on a scale | 6 Weeks to 2 Years Post-op, based on on the intervals listed |
|
|
Overall Study
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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 | LPS Flex Fixed Bearing Knee | Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee. | 13 | 164 | 27 | 164 | ||
| EG001 | LPS Standard Knee | Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee. | 19 | 167 | 23 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Bleeding | Gastrointestinal disorders |
| |||
| Death | General disorders |
| |||
| Other Knee Related Complication (Musculoskeletal and Connective Tissue Disorders) | Musculoskeletal and connective tissue disorders |
| |||
| Stiff Knee Resulting in Manipulation | Musculoskeletal and connective tissue disorders |
| |||
| Other General Complications (Musculoskeletal and Connective Tissue Disorder) | Musculoskeletal and connective tissue disorders |
| |||
| Other General Complications (Neoplasms benign, malignant and unspecified) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Cardiac Arrhythmia | Cardiac disorders |
| |||
| Congestive Heart Failure | Cardiac disorders |
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| Myocardial Infarction | Cardiac disorders |
| |||
| Patellofemoral Subluxation | Musculoskeletal and connective tissue disorders |
| |||
| Quad Tendon Rupture | Musculoskeletal and connective tissue disorders |
| |||
| Other General Complication (Renal and Urinary Disorders) | Renal and urinary disorders |
| |||
| Other General Complication (Surgical and Medical Procedures) | Surgical and medical procedures |
| |||
| Deep Vein Thrombosis | Vascular disorders |
| |||
| Other General Complication (Ear and Labyrthinth Disorders) | Ear and labyrinth disorders |
| |||
| Other General Complication (Endocrine Disorders) | Endocrine disorders |
| |||
| Patellar Implant Loosening | Musculoskeletal and connective tissue disorders |
| |||
| Other Knee Related Complication (Neoplasms benign, malignant and unspecified) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other General Disorders (GI Disorder) | Gastrointestinal disorders |
| |||
| Other General Complication (Musculoskeletal and Connective Tissue Disorder) | Musculoskeletal and connective tissue disorders |
| |||
| Other Knee Related Complication | Musculoskeletal and connective tissue disorders |
| |||
| Stiff Knee Resulting in Manipulations | Musculoskeletal and connective tissue disorders |
| |||
| Urinary Tract Infection | Renal and urinary disorders |
| |||
| Deep Vein Thrombosis | Vascular disorders |
| |||
| Other General Complication (Vascular Disorder) | Vascular disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kacy Arnold, Associate Director, Clinical Affairs | Zimmer | 574-371-8336 | kacy.arnold@zimmer.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Title | Measurements |
|---|---|
|
| >=65 years |
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| Male |
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| Canada |
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| PostOp ROM @1 Year |
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| PostOp ROM @2 Year |
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