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.
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.
Study Type
OBSERVATIONAL
Enrollment
80
Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGThe 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
Time frame: Immediate post-operative
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months
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