Clinical Trial Finder

Inclusion Criteria:

• - Patient is a minimum of 18 years of age.

• - Independent of study participation, patient is a candidate for commercially available Persona or Legion knee components implanted in accordance with product labeling.

• - Patient has participated in this study-related Informed Consent process.

• - Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee (EC) approved Informed Consent form.

• - Patient is willing and able to complete scheduled study procedures and follow-up evaluations.

Exclusion Criteria:

• - Patient is currently participating in any other surgical intervention studies or pain management studies.

• - Patient has undergone contralateral unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA) within the last 18 months.

• - Hip pathology with significant bone loss (e.g., avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) - Hip pathology severely limiting range of motion (e.g., arthrodesis, severe contracture, chronic severe dislocation) - Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) - Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

- Patients with active knee joint infections (determined clinically at time of pre-op evaluation)

This is a prospective, single center, unblinded, randomized clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, adverse event data, and radiographic outcomes for patients undergoing TKA with one of three instrumentation techniques. This clinical study will include Persona and Legion product families using the ROSA Knee System, KneeAlign navigation system, or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Knee System instrumentation or OrthAlign KneeAlign system compared with conventional TKA instrumentation. The hypothesis is that the ROSA Knee System and KneeAlign system will demonstrate greater accuracy and more consistent component position and greater patient reported outcome scores compared to conventional TKA surgery. The investigators suspect that the ROSA system may be more accurate and precise than the KneeAlign system. A maximum of 300 subjects in each arm (900 total) are to be enrolled in this study. In order to minimize selection bias, the investigator will randomize the instrumentation technique used. Randomization will be accomplished via a random number generator in a 1:1:1 ratio. The subject will know which treatment arm they are in at the time of study consent. They will be ineligible for the study if they ask to change treatment arms. The Principal Investigator and Co-Investigators will be skilled in TKA and experienced implanting Persona or Legion TKA system. Two of the investigators will only be using the Persona TKA system as this is their current standard of practice. One of the other investigators will use the Legion TKA system as this is their standard of practice. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the aforementioned implants. All study subjects will undergo preoperative clinical evaluations prior to their TKA. An a priori power analysis was conducted using G*Power 3.1 Data Analysis program to determine the sample size based on a Cohen's f-statistic of 0.25. Power was set at 0.95 and with an alpha of 0.05. Total sample size based on these parameters was 252 patients. Considering that three surgeons, who perform approximately 250 TKAs per year each, will be involved, the investigators estimate that an ability to enroll approximately one-third of all eligible patients seeking TKA and, thus, set a goal for 300 patients to account for patient attrition after study initiation. Through the use of either conventional, computer navigated or robotic techniques, standard operating procedures will be followed and all surgical procedures will be performed under aseptic conditions. Investigators will implant all commercially available components in compliance with corresponding labeling requirements, and in accordance with appropriate surgical technique(s). Post-surgical management for study subjects will follow the investigator's standard of care for patients undergoing TKA (e.g., prophylactic antibiotic therapy, prevention of deep vein thrombosis, prevention of pulmonary embolism, etc.). Post-surgical rehabilitative therapy will be as prescribed by the investigator. Post-operative clinical evaluation will be conducted at approximately 6 weeks, 3 months, 6 months and 1 year post-operatively. Subjects will be followed post-operatively for 1 year.

Arms

Active Comparator: ROSA

Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the ROSA Knee System.

Active Comparator: KneeAlign

Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the KneeAlign navigation system.

No Intervention: Conventional

Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using conventional instrumentation.

Interventions

Device: - ROSA Knee System

The Zimmer Biomet ROSA Knee System is a commercially available, FDA approved robotic assistant for performing TKA. It uses preoperative x-rays to create a three-dimensional image of the patient's knee anatomy which is used to create a preoperative template of the implants to be used and provides intraoperative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks.

Device: - KneeAlign Computer Assisted Navigation System

The OrthAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position.