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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Arthroplasty, Total

Intervention / Treatment
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* Device: Optetrak Logic CR Knee System


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomization list (block randomized, computer generated, two equal-size groups) will be created within the EDC system
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Restricted Invers Kinematic Knee Alignment Technique<br>Restricted Invers Kinematic Knee Alignment Technique | Device: Optetrak Logic CR Knee System<br>* The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.<br>* Other names: Exactech Guided Personalized Surgery;|
| Other: Mechanical Knee Alignment Technique<br>Mechanical Knee Alignment Technique | Device: Optetrak Logic CR Knee System<br>* The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.<br>* Other names: Exactech Guided Personalized Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) | Validated outcome score | 3-month | 
| Knee Society Score (KSS) | Validated outcome score | 6-month | 
| Knee Society Score (KSS) | Validated outcome score | 12-month | 
| Forgotten Joint Score (FJS) | Validated outcome score | 3-month | 
| Forgotten Joint Score (FJS) | Validated outcome score | 6-month | 
| Forgotten Joint Score (FJS) | Validated outcome score | 12-month | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Validated outcome score | 3-month | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Validated outcome score | 6-month | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Validated outcome score | 12-month | 
| Visual Analog Scale (VAS) - Pain | Visual scale from 1-10 (low score is better) | 3-month | 
| Visual Analog Scale (VAS) - Pain | Visual scale from 1-10 (low score is better) | 6-month | 
| Visual Analog Scale (VAS) - Pain | Visual scale from 1-10 (low score is better) | 12-month | 
| Visual Analog Scale (VAS) - Patient Satisfaction | Visual scale from 1-10 (high score is better) | 3-month | 
| Visual Analog Scale (VAS) - Patient Satisfaction | Visual scale from 1-10 (high score is better) | 6-month | 
| Visual Analog Scale (VAS) - Patient Satisfaction | Visual scale from 1-10 (high score is better) | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Alignment | Characterization of knee in terms of ligament balancing will be assessed through constant-pressure full arc of motion measurement. | Intraoperative |