Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty

Study Overview
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Brief Summary
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This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.

Detailed Description
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This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients with Medacta GMK Sphere knee system using patient specific instrumentation Medacta MyKnee. Patients will be assessed a pre-operative, operative and interim post-operative visits, week 6, month 6 and 1,2,5 & 10 years. There will be a phone survey follow up at year 3,4,6,7,8,& 9.

Official Title
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A Prospective, Randomized, Single-Blinded, Multi-Center, Clinical Trial Comparing Kinematic Alignment vs. Mechanical Alignment Using Medially-Stabilized Knee (GMK Sphere) And Patient-Specific Cutting Guides (MyKnee) For Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis, Knee Pain Chronic

Intervention / Treatment
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* Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides
* Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF). Ability to understand and provide written authorization for use and disclosure of personal health information. Subject who are able and willing to comply with the study protocol and follow-up visits. Must be 21 years or older to participate, and less than 80 years old. Subjects must have osteoarthritis knee disease in the affected knee compliant with the FDA-approved indications for use of GMK Sphere knee system and MyKnee cutting blocks. Patients who are candidates for Total Knee Arthroplasty and are determined to undergo a TKA using the Medacta GMK Sphere implant and MyKnee cutting blocks will be offered enrollment. Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete PRO questionnaires, physical exam and radiographs. Exclusion Criteria: • Cases of extreme bone loss requiring an augmented femoral or tibial implant and chronic ligamentous laxity requiring a constrained implant The patient has a fixed flexion deformity of ≥15° The patient has less than 90° of flexion Patient is morbidly obese (BMI ≥40) Patient with inflammatory arthritis History of prior deep knee infection History of alcoholism or drug abuse Currently on chemotherapy or radiation therapy for neoplastic disease Patient currently on immunosuppressive medications including steroids except when, (a) steroid use is less than 10mg daily, (b) other immunosuppressive medications are held for appropriate time, for example Adalimumab is held 2 weeks prior and 2 weeks after surgery History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys Habitual use of narcotic pain medications prior to surgery (more than 2 doses daily and chronic use of a minimum 3 months) History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts) History of chronic pain issues for reasons other than knee joint pain. If the type of pain affects activities of daily living, do not enroll. If the pain is intermittent and does not affect activities of daily living, it is OK to enroll. Fibromyalgia is exclusionary. Women who are pregnant Patient with unstable psychiatric illness or psychosis is excluded. (Patients with stable anxiety or depression can be enrolled if PI determines that the condition does not adversely affect study outcomes & requirements) Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure. Prior surgery on the target knee other than arthroscopy and/or arthroscopically-assisted ligament reconstruction Prior high tibial osteotomy (HTO) or femoral osteotomy Malunion of fracture of a tibia or femur Patient with a neuromuscular or neurosensory deficiency Patient with history of knee fusion in the affected joint

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unrestricted Kinematic Alignment<br>Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides | Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides<br>* MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Unrestricted KA places the implant in a custom position for each patient, completely matching individual anatomy and restoring natural alignment to that of the prearthritic knee.<br>|
| Active Comparator: Restricted Kinematic Alignment<br>Mechanical Alignment and restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides | Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides<br>* MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Restricted KA places the implant in a custom position for each patient, closely matching with anatomy and natural alignment of the individual's knee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Forgotten Joint Score | Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Knee Forgotten Joint Score | Post operative 4-132 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Knee Osteoarthritis Outcome Score (KOOS) | Assessment of improvement of activity levels following knee replacement surgery using the KOOS | Baseline to Post operative 4-132 months | 
| Change from baseline in Knee Society Score | Patient specific patient outcomes scoring | Baseline to Post operative 4-132 months | 
| Change from baseline in Knee Society Score | Clinical Exam Range of Motion, Stability and Alignment | Baseline to Post operative 4-132 months | 
| Change from baseline in PROMIS | Pain Intensity, Pain Interference, and physical function scoring | Baseline to Post operative 4-132 months | 
| Change in Baseline in Knee Alignment | Determined by radiographic analysis measured by angle of degrees | Baseline to Post operative 4-132 months | 
| Change from Baseline of Implant Position Fixation | Determined by radiographic analysis by measure radio lucent lines in millimeters | Baseline to Post operative 4-132 months |