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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
93
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.
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
Sumitomo Hopital
Osaka, Osaka, Japan
Japanese Red Cross Medical Center
Shibuya City, Tokyo, Japan
Yamaguchi Prefectural Grand Medical Center
Hōfu, Yamaguchi, Japan
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
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
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
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
Surgery Time
Surgery time from skin incision to closure
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 month postoperative