Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Study Overview
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Brief Summary
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MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.

Official Title
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Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Conditions
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Joint Diseases, Osteoarthritis, Arthritis Knee, Avascular Necrosis

Intervention / Treatment
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* Device: EVOLUTION® NitrX™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert Has previously undergone or currently has determined to undergo a primary TKA for any of the following: non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; inflammatory degenerative joint disease including rheumatoid arthritis; correction of functional deformity; Willing to voluntarily sign the informed consent form Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit. Previously implanted subjects must be enrolled within 14 months of their primary TKA implantation. Prospective enrollment of a previously unimplanted contralateral knee is permitted in this study provided: the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) are used, all other aspects of the Inclusion/Exclusion Criteria are satisfied, enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and the subject agrees to a second Informed Consent document and data collection specific to the second TKA. Bilateral subjects can have both TKAs enrolled in the study provided: the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) were implanted in both, all other aspects of the Inclusion/Exclusion Criteria are satisfied, enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and the subject agrees to a second Informed Consent document and data collection specific to the second TKA. Bilateral implantation can occur at different time periods for the same subject. Exclusion Criteria: Skeletally immature (less than 21 years of age) at time of implantation Has or had an overt infection at the time of implantation Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable Currently enrolled in another clinical investigation which could affect the endpoints of this protocol Has documented substance abuse issues Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Currently incarcerated or has impending incarceration Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly or previously implanted patients<br>Multicenter, non-interventional prospective follow-up of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 14 months of the study index surgery. Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert | Device: EVOLUTION® NitrX™<br>* EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia | The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year | 10 years post-operative | 
| Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur | The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year. | 10 years post-operative | 
| Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts | The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year. | 10 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Scores | To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS). | 10 years post-operative | 
| Functional Scores | To assess functional scores utilizing EQ-5D-5L. | 10 years post-operative | 
| Functional Scores | To assess functional scores utilizing Forgotten Joint Score (FJS). | 10 years post-operative | 
| Subject Satisfaction | To assess subject satisfaction with their TKA procedure via the Satisfaction Survey. | 10 years post-operative | 
| Radiolucencies | To assess the presence of radiolucencies surrounding the implanted femoral and tibial components present in each of the 17 zones. | 10 years post-operative | 
| To assess subject safety: Adverse Events | To assess safety of the EVOLUTION® NitrX™ system through device-related adverse event findings and/or adverse device effects during follow-up visits. | 1, 3, 5, 7, 10 years | 
| To assess device tolerability within subject: Adverse Events | To assess tolerability of the EVOLUTION® NitrX™ system service-related adverse event findings and/or adverse device effects during follow-up visits. | 10 years post-operative |