NCT Number: NCT03227692
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Sumitomo Hopital, Osaka, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria.
Study Specific Requirements for Principal Investigator/Site
Exclusion criteria
Absolute contraindications include:
Additional contraindications include:
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.
Other names: Persona Knee
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
Other names: TKA
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative, an average of 2 hours
Surgery time from skin incision to closure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 month postoperative
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 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.
Zimmer Biomet
Industry
Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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