ROSA Knee Intraoperative Planning Flexibility Study

Study Overview
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Brief Summary
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The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.

Detailed Description
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The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique. The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan & intra-op final plan. The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.

Official Title
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ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study

Conditions
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Osteo Arthritis Knee, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Total Knee Replacement (TKR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years and over Skeletally matured Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study Willing and able to complete scheduled follow-up evaluations as described in the study protocol Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form Exclusion Criteria: Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft Is septic, has an active infection or has osteomyelitis at the affected joint Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery Has any concomitant disease which is likely to jeopardize the functioning or success of the implant Is known to be pregnant Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails Has a known sensitivity or allergy to one or more of the implanted materials

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TKA with ROSA Knee<br>Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system | Device: Total Knee Replacement (TKR)<br>* Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan | The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments | Immediate post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, range of knee motion and functional performance | The Knee Society Score 2011, and Physical Exam to evaluate pain, range of knee motion and functional performance | Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months | 
| QOL | Subject quality-of-life will be measured by the EuroQol 5 dimensions 5-level (EQ-5D-5L) | Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months | 
| Rehabilitation record | Recovery of patient will be assessed by prescribed Rehabilitation record and compliance | Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months | 
| Kinematic analysis | Kinematic analysis will be conducted to visualize postoperative knee motion | Postoperative 12 months or 24 months | 
| Image review (CT/Radiograph) | Image review (CT/Radiograph) to assess the accuracy of the implant position, radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc. | Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months |