Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment

Launched by EXACTECH · Aug 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of performing total knee replacement surgery, known as total knee arthroplasty (TKA). Specifically, it compares "restricted inverse kinematic alignment" (iKA) with "mechanical alignment" (MA), both of which use navigation assistance during surgery. The aim is to see how these methods affect patients' recovery and overall satisfaction after the procedure.

To participate in this study, patients must be at least 18 years old and plan to receive a specific type of knee implant called the Optetrak Logic® CR device. They should also be willing to attend required pre- and post-surgery visits and provide written consent to join the trial. However, individuals with certain health issues, such as infections, insufficient bone strength, or those who are pregnant, will not be eligible. Participants can expect to receive careful monitoring during their recovery and contribute to important research that may improve knee surgery outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Subjects must meet all of the following inclusion criteria to be included in the study:
• • 1. Subject must be at least 18 years of age at the time of the surgery (skeletally mature)
• • 2. Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above
• • 3. Subject must be willing to comply with the pre-operative and post-operative visit requirements
• • 4. Subject must be willing and able to provide written informed consent for participation in the study
• Exclusion Criteria:
• * Subjects will be excluded from the study if they meet any of the following exclusion criteria:
• • 1. Subject with a suspected or confirmed systemic infection and/or a secondary remote infection
• • 2. Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
• • 3. Subject without sufficient soft tissue integrity to provide adequate stability
• • 4. Subject with either mental or neuromuscular disorders that do not allow control of the knee joint
• • 5. Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system
• • 6. Subject is participating in another drug or device study other than knee replacement within the last three (3) months
• • 7. Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions
• • 8. Subject is a prisoner
• • 9. Subject is pregnant
• • 10. Subject is undergoing radiation therapy where the targeted field involves the knee joint
• • 11. Subjects with malignancy involving proximal tibia, distal femur, or knee joint
• • 12. Subjects undergoing active administration of chemotherapy