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The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
Objective： To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
Endpoint： Primary： The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.
Secondary：Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona with iASSIST Knee | Experimental | Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. |
|
| Persona without iASSIST Knee | Active Comparator | Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persona Knee System | Device | 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 |
|---|---|---|
| Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery. | Postoperative 6 months |
| Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery. | Postoperative 6 months |
| Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery. | Postoperative 6 months |
| Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery. | Postoperative 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Time | Surgery time from skin incision to closure | Intraoperative, an average of 2 hours |
| Number of Instrument Trays Used | Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits. |
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Inclusion Criteria:
In order to be eligible to participate in this study, a patient must meet all of the following criteria.
Study Specific Requirements for Principal Investigator/Site
Exclusion Criteria:
Absolute contraindications include:
Additional contraindications include:
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| Name | Affiliation | Role |
|---|---|---|
| Toshihiro Ohdera, M.D. | Fukuoka Orthopaedic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumitomo Hopital | Osaka | Osaka | 530-0005 | Japan | ||
| Japanese Red Cross Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Persona With iASSIST Knee | Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. |
| FG001 | Persona Without iASSIST Knee | Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Persona With iASSIST Knee | Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. |
| 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 | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery. | Patients who have CT data at 6 month after surgery were included in the analysis. | Posted | Count of Participants | Participants | Postoperative 6 months |
|
Surgery to 6 month postoperative 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 | Persona With iASSIST Knee | Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. iAssist Knee: Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant Lymphoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative Supracondylar Fracture of femur | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager of Clinical Affairs | Zimmer Biomet G.K. | +81-3-6402-6610 | 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 | Apr 27, 2018 | Jan 29, 2020 | Prot_SAP_000.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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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
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Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
|
|
| Total Knee Arthroplasty | Procedure | Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. |
|
|
| iAssist Knee | Device | Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone. |
|
| Intraoperative |
| KSS - Objective Score at 6 Month Postoperatively | 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. Higher score means better outcomes. | 6 month postoperative |
| KSS-Patient Satisfaction at 6 Month Postoperatively | 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. | 6 month postoperative |
| KSS-function Score at 6 Month Postoperatively | 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. | 6 month postoperative |
| KSS-Patient Expectations at 6 Month Postoperatively | 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. | 6 month postoperative |
| Oxford Knee Score at 6 Month Postoperatively | Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome. | 6 month postoperative |
| EQ-5D-3L at 6 Month Postoperatively | 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. | 6 month postoperative |
| Shibuya City |
| Tokyo |
| 150-8935 |
| Japan |
| Yamaguchi Prefectural Grand Medical Center | Hōfu | Yamaguchi | 747-8511 | Japan |
| Adverse Event |
|
| BG001 | Persona Without iASSIST Knee | Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. Higher score means better outcomes. | Mean | Standard Deviation | score on scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on scale |
|
| Oxford Knee Score | Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome. | Mean | Standard Deviation | score on scale |
|
| EQ-5D-3L | 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. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Persona Without iASSIST Knee | Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. |
|
|
| Primary | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery. | Patients who have CT data at 6 month after surgery were included in the analysis. | Posted | Count of Participants | Participants | Postoperative 6 months |
|
|
|
| Primary | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery. | Patients who have CT data at 6 month after surgery were included in the analysis. | Posted | Count of Participants | Participants | Postoperative 6 months |
|
|
|
| Primary | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery. | Patients who have CT data at 6 month after surgery were included in the analysis. | Posted | Count of Participants | Participants | Postoperative 6 months |
|
|
|
| Secondary | Surgery Time | Surgery time from skin incision to closure | Posted | Mean | Standard Deviation | minutes | Intraoperative, an average of 2 hours |
|
|
|
| Secondary | Number of Instrument Trays Used | Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits. | Posted | Mean | Standard Deviation | trays | Intraoperative |
|
|
|
| Secondary | KSS - Objective Score at 6 Month Postoperatively | 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. Higher score means better outcomes. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| Secondary | KSS-Patient Satisfaction at 6 Month Postoperatively | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| Secondary | KSS-function Score at 6 Month Postoperatively | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| Secondary | KSS-Patient Expectations at 6 Month Postoperatively | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| Secondary | Oxford Knee Score at 6 Month Postoperatively | Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| Secondary | EQ-5D-3L at 6 Month Postoperatively | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Persona Without iASSIST Knee | Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Persona Knee System: 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. Total Knee Arthroplasty: Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis. | 0 | 41 | 1 | 41 | 1 | 41 |
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| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |