Gait and Functional Outcomes Study Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants

Study Overview
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Brief Summary
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MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous study which showed the Medial Pivot (MP) system required lower quadriceps activation than subjects implanted with a Posterior stabilized (PS) system preforming the same activities of daily living.

Detailed Description
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MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous study which showed the Medial Pivot (MP) system required lower quadriceps activation than subjects implanted with a Posterior stabilized (PS) system preforming the same activities of daily living. The propose of the current study is to determine the impact of Total Knee Arthroplasty (TKA) design on muscle activation following TKA surgery.

Official Title
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Muscle Activation and Biomechanical Function of the Lower-limb Joints Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants: an Electromyography Study

Conditions
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Joint Disease

Intervention / Treatment
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* Device: Group 1 (Medial-Pivot)
* Device: Group 2 (Posterior-Stabilized)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in Groups 1 and 2, subjects must meet all of the following criteria: Subject is a candidate for unilateral primary TKA for degenerative or traumatic osteoarthritis Subject is a candidate to be implanted with the specified combination of components for either Group 1 or 2 Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visits and assessments Subject plans to be available through the 1 year postoperative follow-up visit Subject is willing to sign the approved Informed Consent document To be included in Group 3, subjects must meet all of the following criteria: Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visit and assessments Subject is willing to sign the approved Informed Consent document Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0 kg/m2 and 102.0 cm respectively for men and 35.0 kg/m2 and 88.0 cm respectively for women at screening. Groups 1 & 2 Only: Subject has degenerative conditions (other than osteoarthritis in the enrolled TKA) impacting joints of the lower extremities, previous joint replacement of the enrolled knee or other lower limb joint replacement, or any other past or present condition, which in the opinion of the Investigator may impact gait. Group 3 Only: Subject has degenerative condition impacting joints of the lower extremities, any previous joint replacement in the knees, or any other past or present condition, which in the opinion of the Investigator may impact gait. Groups 1 and 2 Only: Subjects with a Kellgren-Lawrence Grading Scale of ≥2 on the contralateral knee if having severe pain or abnormal gait patterns. Subject is currently enrolled in another clinical investigation related to lower limbs which could affect the endpoints of this protocol. Subject is unwilling or unable to sign the Informed Consent document Subject has documented substance abuse issues Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Subject is currently incarcerated or has impending incarceration

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 76 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (Medial-Pivot)<br>Group 1 will be implanted with the EVOLUTION® MP System with Cruciate Sacrificing (CS) tibial inserts. | Device: Group 1 (Medial-Pivot)<br>* EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts<br>* Other names: EVOLUTION®;|
| Group 2 (Posterior-Stabilized)<br>Group 2 will be implanted with the Zimmer® NexGen® PS TKA system. | Device: Group 2 (Posterior-Stabilized)<br>* Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts<br>* Other names: NexGen®;|
| Group 3 (Control Group)<br>Non-implanted control subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Limb Muscle Activation Comparison as Assessed by Maximum Voluntary Isometric Contraction Muscle Strength and Dynamic Muscle Activation Measurements in Total Knee Arthroplasty Subjects Implanted with Medial-pivot or Posterior-stabilized Implants | Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation | Presurgery and 12 Months Post Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare lower limb muscle activation between the control group (Group 3) and Groups 1 and 2, as assessed by maximum voluntary isometric contraction muscled strength and dynamic muscle activation measurements | Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation | Presurgery and 12 Months Post Surgery for implanted subjects | 
| Compare functional outcomes for the Groups 1 and 2 as assessed by the Timed Up & Go (TUG) test | Measured by Timed Up & Go (TUG) test | Presurgery and 12 Months Post Surgery for implanted subjects | 
| Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores | Measured by KOOS Scores | Presurgery and 12 Months Post Surgery for implanted subjects | 
| Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2 | Measured by Patient Satisfaction Survey | 12 Months Post Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, correction of functional deformity, procedures, traumatic osteoarthritis, degenerative osteoarthritis, total knee arthroplasty, Healthy Volunteers, electromyography, Musculoskeletal Diseases