Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 93
- Locations
- 3
- Primary Endpoint
- Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
- •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.
Arms & Interventions
Persona with iASSIST Knee
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Intervention: Persona Knee System (Device)
Persona with iASSIST Knee
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Intervention: Total Knee Arthroplasty (Procedure)
Persona with iASSIST Knee
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Intervention: iAssist Knee (Device)
Persona without iASSIST Knee
Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
Intervention: Total Knee Arthroplasty (Procedure)
Persona without iASSIST Knee
Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
Intervention: Persona Knee System (Device)
Outcomes
Primary Outcomes
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain
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.
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain
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.
Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain
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.
Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain
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.
Secondary Outcomes
- Number of Instrument Trays Used(Intraoperative)
- KSS-function Score at 6 Month Postoperatively(6 month postoperative)
- EQ-5D-3L at 6 Month Postoperatively(6 month postoperative)
- KSS - Objective Score at 6 Month Postoperatively(6 month postoperative)
- KSS-Patient Satisfaction at 6 Month Postoperatively(6 month postoperative)
- Surgery Time(Intraoperative, an average of 2 hours)
- KSS-Patient Expectations at 6 Month Postoperatively(6 month postoperative)
- Oxford Knee Score at 6 Month Postoperatively(6 month postoperative)