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To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encore Mobile-Bearing Knee | Device | Used for primary total knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score Evaluation | The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70). | 2 year |
| Knee Society Function Score | The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome. | 2 year |
| Knee Society Scores Used as Success/Failure Criteria. | The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success. | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl T. Hayden VA Hospital | Phoenix | Arizona | 85012 | United States | ||
| Orange Coast Memorial Medical Center |
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| Label | URL |
|---|---|
| Sponsor company home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Bearing Knee | Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Bearing Knee | Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant. |
| 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 | Knee Society Score Evaluation | The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70). | Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data. | Posted | Mean | Standard Deviation | Average Knee Rating Score | 2 year |
|
Adverse events were collected from the date of surgery through the 2 year visit.
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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 | Mobile Bearing Knee | Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Affairs | DJO Surgical | 512-832-9500 | 1323 | jane.jacob@djosurgical.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Fountain Valley |
| California |
| 92708 |
| United States |
| S.Florida VA Found. For Research & Education, Inc. | Miami | Florida | 33125 | United States |
| Great Lakes Orthopaedics | Garden City | Michigan | 48135 | United States |
| Hilton Head Island | South Carolina | 29926 | United States |
| Orthopedic Surgery Center and Sports Medicine | Edinburg | Texas | 78539 | United States |
| The Orthopedic Specialty Hospital | Murray | Utah | 84107 | United States |
| West Jordan | Utah | 84084 | United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Knee Society Function Score | The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome. | Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data. | Posted | Mean | Standard Deviation | Average Knee Function Score | 2 year |
|
|
|
| Primary | Knee Society Scores Used as Success/Failure Criteria. | The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success. | Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data. | Posted | Number | Percentage of Participants with Success | 2 year |
|
|
|
| 0 |
| 419 |
| 281 |
| 419 |
| Cancer | Immune system disorders |
|
| Degenerative Arthritis | Musculoskeletal and connective tissue disorders |
|
| Knee device clicking | Injury, poisoning and procedural complications |
|
| Edema | Blood and lymphatic system disorders |
|
| Fracture | Musculoskeletal and connective tissue disorders |
|
| Heart Complications | Cardiac disorders |
|
| Infections | Infections and infestations |
|
| Neurological disorder and numbness | Nervous system disorders |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
|
| Swelling | Vascular disorders |
|
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| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |