Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
NCT ID: NCT04816773
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
150 participants
OBSERVATIONAL
2022-01-27
2035-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
EVOLUTION® NitrX™
EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Interventions
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EVOLUTION® NitrX™
EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Eligibility Criteria
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Inclusion Criteria
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,
Exclusion Criteria
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,
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.
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
21 Years
ALL
No
Sponsors
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MicroPort Orthopedics Inc.
INDUSTRY
Responsible Party
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Locations
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Sah Orthopaedic Associates
Fremont, California, United States
MSK Doctors, The Keep Clinic
Grantham, Lincolnshire, United Kingdom
Countries
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Other Identifiers
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20K001
Identifier Type: -
Identifier Source: org_study_id
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