Persona TKA With iASSIST Knee System and iASSIST Knee System
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: Persona Knee SystemProcedure: Total Knee ArthroplastyDevice: iAssist Knee
- Registration Number
- NCT03227692
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Persona with iASSIST Knee Persona Knee System Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona with iASSIST Knee iAssist Knee Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona with iASSIST Knee Total Knee Arthroplasty Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee. Persona without iASSIST Knee Persona Knee System Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee. Persona without iASSIST Knee Total Knee Arthroplasty Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
- Primary Outcome Measures
Name Time Method Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain 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.
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain 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.
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain 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.
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain 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.
- Secondary Outcome Measures
Name Time Method Number of Instrument Trays Used 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.
KSS-function Score at 6 Month Postoperatively 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.EQ-5D-3L at 6 Month Postoperatively 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.KSS - Objective Score at 6 Month Postoperatively 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.KSS-Patient Satisfaction at 6 Month Postoperatively 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.
Surgery Time Intraoperative, an average of 2 hours Surgery time from skin incision to closure
KSS-Patient Expectations at 6 Month Postoperatively 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.Oxford Knee Score at 6 Month Postoperatively 6 month postoperative Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.
Trial Locations
- Locations (3)
Yamaguchi Prefectural Grand Medical Center
🇯🇵Hōfu, Yamaguchi, Japan
Sumitomo Hopital
🇯🇵Ōsaka, Osaka, Japan
Japanese Red Cross Medical Center
🇯🇵Shibuya, Tokyo, Japan