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Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguard with KneeAlign 2 | Active Comparator | Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. |
|
| Vanguard without KneeAlign 2 | No Intervention | Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KneeAlign 2 | Device | Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups. | Postoperative 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees) | Postoperative 6 months |
| Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yukihide Minoda | Osaka City University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka City University | Osaka | 558-0022 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vanguard With KneeAlign 2 | Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. |
| FG001 | Vanguard Without KneeAlign 2 | Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vanguard With KneeAlign 2 | Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. |
| 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 | Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups. | Posted | Count of Participants | Participants | Postoperative 6 months |
|
From surgery to 6 month 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 | Vanguard With KneeAlign 2 | Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Postoperative infection |
Image assessment, which is primary endpoint, was done on 2D x-ray (not based on CT).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Senior Manager | Zimmer Biomet G.K. | +81-6402-6777 | takahito.nakai@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2016 | Sep 5, 2019 | Prot_SAP_001.pdf |
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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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|
|
Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees) |
| Postoperative 6 months |
| Number of Participants With Adverse Events and/or Adverse Device Effects | Number of participants, who experience adverse events and/or adverse device effects | Intra-operative and Post-operative 6 months |
| BG001 | Vanguard Without KneeAlign 2 | Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| EQ-5D-3L | Measure Description: EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000. Higher score means better outcomes. | Missing data on 6 KneeAlign group patients and 5 Conventional group patients. Failed to answer all questions on the form. | Mean | Standard Deviation | point |
|
| KSS-Objective Score | KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0. "Alignment" has a maximum of 25 points. "Instability" allows a maximum of 25 points. "Joint Motion" allows one point for each 5° of joint motion and allows greater than 25 points for patients with greater than 125° of motion. There are deductions for flexion contracture and extension lag. "Symptoms" category has maximum allowable points 25. Higher score means better outcomes. | Missing data on 9 KneeAlign2 patients and on 9 Conventional patients. Failed to obtain data. | Mean | Standard Deviation | point |
|
| KSS-Patient Satisfaction | KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0. Higher score means better outcomes. | Missing data, 5 KneeAlign2 patients and 5 conventional patients. Failed to answer all questions on the form. | Mean | Standard Deviation | point |
|
| KSS-Function Score | KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100. "Walking and Standing" has a maximum value of 30 points, "Standard Activities" has a maximum of 30 points, "Advanced Activities" has a maximum of 25 points and "Discretionary Activities" has a maximum of 15 points. Lowest possible score is 0. Higher score means better outcomes. | Missing data on 8 KneeAlign2 patients and 12 Conventional patients. Failed to answer all questions on the form. | Mean | Standard Deviation | point |
|
| KSS-Patient Expectation | KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function. The score ranges from 3 to 15. Higher score means better outcomes. | Missing data on 16 KneeAlign2 patients and 13 conventional patients. Failed to answer all questions on the form | Mean | Standard Deviation | point |
|
| Oxford Knee Score | Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome. | Missing data on 7 KneeAlign2 patients and 3 Conventional patients. Failed to answer all questions on the form. | Mean | Standard Deviation | point |
|
| Vanguard Without KneeAlign 2 |
Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. |
|
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| Secondary | Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees) | Posted | Count of Participants | Participants | Postoperative 6 months |
|
|
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| Secondary | Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees) | Posted | Count of Participants | Participants | Postoperative 6 months |
|
|
|
| Secondary | Number of Participants With Adverse Events and/or Adverse Device Effects | Number of participants, who experience adverse events and/or adverse device effects | Posted | Count of Participants | Participants | Intra-operative and Post-operative 6 months |
|
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| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Vanguard Without KneeAlign 2 | Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. | 0 | 50 | 0 | 50 | 0 | 50 |
|
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| D012216 |
| Rheumatic Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|