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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. 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; 3.

Willing to voluntarily sign the informed consent form. 4. 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. 5. 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: 1. 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, 2. all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and. 4. 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: 1. 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, 2. all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and. 4. 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:

1. Skeletally immature (less than 21 years of age) at time of implantation. 2. Has or had an overt infection at the time of implantation. 3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation. 4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation. 5. 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. 6. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol. 7. Has documented substance abuse issues. 8. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study. 9. Currently incarcerated or has impending incarceration. 10. 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04816773
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MicroPort Orthopedics Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Joint Diseases, Osteoarthritis, Arthritis Knee, Avascular Necrosis

Arms & Interventions

Arms

: Newly or previously implanted patients

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

Interventions

Device: - EVOLUTION® NitrX™

EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sah Orthopaedic Associates, Fremont, California

Status

Address

Sah Orthopaedic Associates

Fremont, California, 94538

International Sites

MSK Doctors, The Keep Clinic, Grantham, Lincolnshire, United Kingdom

Status

Address

MSK Doctors, The Keep Clinic

Grantham, Lincolnshire, NG31 9AS

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