Persona TKA With iASSIST Knee System and iASSIST Knee System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Persona Knee System
* Procedure: Total Knee Arthroplasty
* Device: iAssist Knee


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persona with iASSIST Knee<br>Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. | Device: Persona Knee System<br>* 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.<br>* Other names: Persona Knee;Procedure: Total Knee Arthroplasty<br>* Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.<br>* Other names: TKA;Device: iAssist Knee<br>* Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.<br>|
| Active Comparator: Persona without iASSIST Knee<br>Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. | Device: Persona Knee System<br>* 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.<br>* Other names: Persona Knee;Procedure: Total Knee Arthroplasty<br>* Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.<br>* Other names: TKA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |