Trial Outcomes & Findings for Persona TKA With iASSIST Knee System and iASSIST Knee System (NCT NCT03227692)
NCT ID: NCT03227692
Last Updated: 2020-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Postoperative 6 months
Results posted on
2020-07-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
COMPLETED
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Persona TKA With iASSIST Knee System and iASSIST Knee System
Baseline characteristics by cohort
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 9.0 • n=39 Participants
|
76.1 years
STANDARD_DEVIATION 9.0 • n=41 Participants
|
74.8 years
STANDARD_DEVIATION 9.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
42 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
83 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Japan
|
42 participants
n=39 Participants
|
41 participants
n=41 Participants
|
83 participants
n=35 Participants
|
|
KSS - Objective Score
|
34.8 score on scale
STANDARD_DEVIATION 20.2 • n=39 Participants
|
36.1 score on scale
STANDARD_DEVIATION 19.8 • n=41 Participants
|
35.4 score on scale
STANDARD_DEVIATION 19.9 • n=35 Participants
|
|
KSS-Patient Satisfaction
|
12.7 score on a scale
STANDARD_DEVIATION 6.3 • n=39 Participants
|
15.1 score on a scale
STANDARD_DEVIATION 6.1 • n=41 Participants
|
13.9 score on a scale
STANDARD_DEVIATION 6.3 • n=35 Participants
|
|
KSS-Function Score
|
38.5 score on a scale
STANDARD_DEVIATION 0.2 • n=39 Participants
|
39.1 score on a scale
STANDARD_DEVIATION 17.6 • n=41 Participants
|
38.8 score on a scale
STANDARD_DEVIATION 18.9 • n=35 Participants
|
|
KSS-Patient Expectation
|
13.1 score on scale
STANDARD_DEVIATION 2.0 • n=39 Participants
|
12.9 score on scale
STANDARD_DEVIATION 1.7 • n=41 Participants
|
13.0 score on scale
STANDARD_DEVIATION 1.9 • n=35 Participants
|
|
Oxford Knee Score
|
22.0 score on scale
STANDARD_DEVIATION 9.1 • n=39 Participants
|
25.0 score on scale
STANDARD_DEVIATION 8.4 • n=41 Participants
|
23.5 score on scale
STANDARD_DEVIATION 8.8 • n=35 Participants
|
|
EQ-5D-3L
|
0.6 score on a scale
STANDARD_DEVIATION 0.2 • n=39 Participants
|
0.6 score on a scale
STANDARD_DEVIATION 0.1 • n=41 Participants
|
0.6 score on a scale
STANDARD_DEVIATION 0.1 • n=35 Participants
|
PRIMARY outcome
Timeframe: Postoperative 6 monthsPopulation: Patients who have CT data at 6 month after surgery were included in the analysis.
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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
within 3 degrees
|
39 Participants
|
36 Participants
|
|
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
outlier
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Postoperative 6 monthsPopulation: Patients who have CT data at 6 month after surgery were included in the analysis.
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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
within 3 degrees
|
36 Participants
|
24 Participants
|
|
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
outlier
|
6 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Postoperative 6 monthsPopulation: Patients who have CT data at 6 month after surgery were included in the analysis.
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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
within 3 degrees
|
32 Participants
|
23 Participants
|
|
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
outlier
|
10 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Postoperative 6 monthsPopulation: Patients who have CT data at 6 month after surgery were included in the analysis.
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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
within 3 degrees
|
34 Participants
|
32 Participants
|
|
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
outlier
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Intraoperative, an average of 2 hoursSurgery time from skin incision to closure
Outcome measures
| Measure |
Persona With iASSIST Knee
n=47 Participants
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.
|
Persona Without iASSIST Knee
n=46 Participants
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.
|
|---|---|---|
|
Surgery Time
|
125.1 minutes
Standard Deviation 34.6
|
114.2 minutes
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: IntraoperativeNumber of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=47 Participants
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.
|
Persona Without iASSIST Knee
n=46 Participants
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.
|
|---|---|---|
|
Number of Instrument Trays Used
|
5.2 trays
Standard Deviation 2.2
|
4.9 trays
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 6 month postoperativeKSS-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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
KSS - Objective Score at 6 Month Postoperatively
|
80.8 score on a scale
Standard Deviation 13.9
|
77.2 score on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 6 month postoperativeKSS-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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=45 Participants
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.
|
Persona Without iASSIST Knee
n=45 Participants
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.
|
|---|---|---|
|
KSS-Patient Satisfaction at 6 Month Postoperatively
|
24.6 score on a scale
Standard Deviation 8.2
|
25.0 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 6 month postoperativeKSS-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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
KSS-function Score at 6 Month Postoperatively
|
61.6 score on a scale
Standard Deviation 23.7
|
61.5 score on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 6 month postoperativeKSS-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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
KSS-Patient Expectations at 6 Month Postoperatively
|
9.5 score on a scale
Standard Deviation 3.1
|
10.1 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 6 month postoperativePatient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
Oxford Knee Score at 6 Month Postoperatively
|
36.2 score on a scale
Standard Deviation 9.2
|
37.7 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 6 month postoperativeEQ-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.
Outcome measures
| Measure |
Persona With iASSIST Knee
n=42 Participants
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.
|
Persona Without iASSIST Knee
n=41 Participants
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.
|
|---|---|---|
|
EQ-5D-3L at 6 Month Postoperatively
|
0.8 score on a scale
Standard Deviation 0.2
|
0.8 score on a scale
Standard Deviation 0.2
|
Adverse Events
Persona With iASSIST Knee
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Persona Without iASSIST Knee
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Persona With iASSIST Knee
n=42 participants at risk
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.
|
Persona Without iASSIST Knee
n=41 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Malignant Lymphoma
|
0.00%
0/42 • Surgery to 6 month postoperative visit
|
2.4%
1/41 • Number of events 1 • Surgery to 6 month postoperative visit
|
Other adverse events
| Measure |
Persona With iASSIST Knee
n=42 participants at risk
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.
|
Persona Without iASSIST Knee
n=41 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Postoperative Supracondylar Fracture of femur
|
0.00%
0/42 • Surgery to 6 month postoperative visit
|
2.4%
1/41 • Number of events 1 • Surgery to 6 month postoperative visit
|
Additional Information
Senior Manager of Clinical Affairs
Zimmer Biomet G.K.
Phone: +81-3-6402-6610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place