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

Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study

The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.

A prospective randomized clinical study will be conducted.

The study will consist of two cohorts and will collect clinical data from a maximum of 148 knee arthroplasty surgeries during which the patient will receive the Optetrak Logic® CR TKA device. Cohorts will consist of 1) subjects undergoing MA TKA and 2) subjects undergoing restricted iKA TKA. All cohorts will utilize navigation-assisted surgery (ExactechGPS®) and will be enrolled and consented concurrently. Subjects will be randomized and have a 50% chance of being assigned to the MA TKA cohort and a 50% chance of being assigned to the restricted iKA TKA cohort. Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study.

Data collection under this protocol shall be conducted in a way that conforms to any applicable local and national rules, regulations, and guidelines relating to the conduct of clinical research and the protection of human subjects. As appropriate, this may include but is not limited to the following: Good Clinical Practice (GCP) requirements, FDA regulations and guidelines, ISO 14155: 2020, ICH guidelines, HIPAA and other regulations pertaining to the protection of patient data and data privacy, guidelines established by local Institutional Review Boards or similar Ethics Committees, the Belmont Report, and the Declaration of Helsinki.

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