Osteoarthritis, Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPersona 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.
PROCEDURETotal Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
DEVICEiAssist Knee
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria. * Knee (either unilateral or bilateral) osteoarthritis (varus deformity only) * Male or female * At least 20 years of age * Patients willing to return for follow-up evaluations. Study Specific Requirements for Principal Investigator/Site * Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities. * Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.
Exclusion criteria
Absolute contraindications include: * Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis) * Too severe OA deformation (FTA: \> 190 degrees/\< 175 degrees) * Active infection (or within 6 weeks after infection) * Sepsis * Osteomyelitis * Any type of implant is inserted in the affected side of lower extremity * Hip and/or foot disease on the affected side Additional contraindications include: * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Diagnosed osteoporosis or osteomalacia * Metabolic disorders which may impair bone formation * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | Postoperative 6 months | 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. |
| Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | Postoperative 6 months | 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. |
| Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | Postoperative 6 months | 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. |
| Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | Postoperative 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KSS-function Score at 6 Month Postoperatively | 6 month postoperative | 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. |
| KSS-Patient Expectations at 6 Month Postoperatively | 6 month postoperative | 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. |
| Surgery Time | Intraoperative, an average of 2 hours | Surgery time from skin incision to closure |
| EQ-5D-3L at 6 Month Postoperatively | 6 month postoperative | 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. |
| Oxford Knee Score at 6 Month Postoperatively | 6 month postoperative | Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome. |
| Number of Instrument Trays Used | Intraoperative | 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. |
| KSS - Objective Score at 6 Month Postoperatively | 6 month postoperative | 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. |
| KSS-Patient Satisfaction at 6 Month Postoperatively | 6 month postoperative | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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. | 41 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Persona Without iASSIST Knee | Persona With iASSIST Knee |
|---|---|---|---|
| Age, Continuous | 74.8 years STANDARD_DEVIATION 9 | 76.1 years STANDARD_DEVIATION 9 | 73.3 years STANDARD_DEVIATION 9 |
| EQ-5D-3L | 0.6 score on a scale STANDARD_DEVIATION 0.1 | 0.6 score on a scale STANDARD_DEVIATION 0.1 | 0.6 score on a scale STANDARD_DEVIATION 0.2 |
| KSS-Function Score | 38.8 score on a scale STANDARD_DEVIATION 18.9 | 39.1 score on a scale STANDARD_DEVIATION 17.6 | 38.5 score on a scale STANDARD_DEVIATION 0.2 |
| KSS - Objective Score | 35.4 score on scale STANDARD_DEVIATION 19.9 | 36.1 score on scale STANDARD_DEVIATION 19.8 | 34.8 score on scale STANDARD_DEVIATION 20.2 |
| KSS-Patient Expectation | 13.0 score on scale STANDARD_DEVIATION 1.9 | 12.9 score on scale STANDARD_DEVIATION 1.7 | 13.1 score on scale STANDARD_DEVIATION 2 |
| KSS-Patient Satisfaction | 13.9 score on a scale STANDARD_DEVIATION 6.3 | 15.1 score on a scale STANDARD_DEVIATION 6.1 | 12.7 score on a scale STANDARD_DEVIATION 6.3 |
| Oxford Knee Score | 23.5 score on scale STANDARD_DEVIATION 8.8 | 25.0 score on scale STANDARD_DEVIATION 8.4 | 22.0 score on scale STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 83 Participants | 41 Participants | 42 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 83 participants | 41 participants | 42 participants |
| Sex: Female, Male Female | 66 Participants | 31 Participants | 35 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 0 / 42 | 1 / 41 |
| serious Total, serious adverse events | 0 / 42 | 1 / 41 |
Outcome results
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.
Time frame: Postoperative 6 months
Population: Patients who have CT data at 6 month after surgery were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | within 3 degrees | 39 Participants |
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | outlier | 3 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | within 3 degrees | 36 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain | outlier | 5 Participants |
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.
Time frame: Postoperative 6 months
Population: Patients who have CT data at 6 month after surgery were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | within 3 degrees | 36 Participants |
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | outlier | 6 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | within 3 degrees | 24 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain | outlier | 17 Participants |
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.
Time frame: Postoperative 6 months
Population: Patients who have CT data at 6 month after surgery were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | within 3 degrees | 32 Participants |
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | outlier | 10 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | within 3 degrees | 23 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain | outlier | 18 Participants |
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.
Time frame: Postoperative 6 months
Population: Patients who have CT data at 6 month after surgery were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | within 3 degrees | 34 Participants |
| Persona With iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | outlier | 8 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | within 3 degrees | 32 Participants |
| Persona Without iASSIST Knee | Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain | outlier | 9 Participants |
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.
Time frame: 6 month postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | EQ-5D-3L at 6 Month Postoperatively | 0.8 score on a scale | Standard Deviation 0.2 |
| Persona Without iASSIST Knee | EQ-5D-3L at 6 Month Postoperatively | 0.8 score on a scale | Standard Deviation 0.2 |
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.
Time frame: 6 month postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | KSS-function Score at 6 Month Postoperatively | 61.6 score on a scale | Standard Deviation 23.7 |
| Persona Without iASSIST Knee | KSS-function Score at 6 Month Postoperatively | 61.5 score on a scale | Standard Deviation 18.6 |
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.
Time frame: 6 month postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | KSS - Objective Score at 6 Month Postoperatively | 80.8 score on a scale | Standard Deviation 13.9 |
| Persona Without iASSIST Knee | KSS - Objective Score at 6 Month Postoperatively | 77.2 score on a scale | Standard Deviation 17.5 |
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.
Time frame: 6 month postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | KSS-Patient Expectations at 6 Month Postoperatively | 9.5 score on a scale | Standard Deviation 3.1 |
| Persona Without iASSIST Knee | KSS-Patient Expectations at 6 Month Postoperatively | 10.1 score on a scale | Standard Deviation 2.5 |
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.
Time frame: 6 month postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | KSS-Patient Satisfaction at 6 Month Postoperatively | 24.6 score on a scale | Standard Deviation 8.2 |
| Persona Without iASSIST Knee | KSS-Patient Satisfaction at 6 Month Postoperatively | 25.0 score on a scale | Standard Deviation 8.3 |
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.
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | Number of Instrument Trays Used | 5.2 trays | Standard Deviation 2.2 |
| Persona Without iASSIST Knee | Number of Instrument Trays Used | 4.9 trays | Standard Deviation 2.1 |
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.
Time frame: 6 month postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | Oxford Knee Score at 6 Month Postoperatively | 36.2 score on a scale | Standard Deviation 9.2 |
| Persona Without iASSIST Knee | Oxford Knee Score at 6 Month Postoperatively | 37.7 score on a scale | Standard Deviation 6.9 |
Secondary
Surgery Time
Surgery time from skin incision to closure
Time frame: Intraoperative, an average of 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persona With iASSIST Knee | Surgery Time | 125.1 minutes | Standard Deviation 34.6 |
| Persona Without iASSIST Knee | Surgery Time | 114.2 minutes | Standard Deviation 32.4 |