- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816773
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
March 19, 2024 updated by: MicroPort Orthopedics Inc.
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lincolnshire
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Grantham, Lincolnshire, United Kingdom, NG31 9AS
- MSK Doctors, The Keep Clinic
-
-
-
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California
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Fremont, California, United States, 94538
- Sah Orthopaedic Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia
Time Frame: 10 years post-operative
|
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
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Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur
Time Frame: 10 years post-operative
|
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
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Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts
Time Frame: 10 years post-operative
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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.
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10 years post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Scores
Time Frame: 10 years post-operative
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To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS).
|
10 years post-operative
|
Functional Scores
Time Frame: 10 years post-operative
|
To assess functional scores utilizing EQ-5D-5L.
|
10 years post-operative
|
Functional Scores
Time Frame: 10 years post-operative
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To assess functional scores utilizing Forgotten Joint Score (FJS).
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10 years post-operative
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Subject Satisfaction
Time Frame: 10 years post-operative
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To assess subject satisfaction with their TKA procedure via the Satisfaction Survey.
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10 years post-operative
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Radiolucencies
Time Frame: 10 years post-operative
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To assess the presence of radiolucencies surrounding the implanted femoral and tibial components present in each of the 17 zones.
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10 years post-operative
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To assess subject safety: Adverse Events
Time Frame: 1, 3, 5, 7, 10 years
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To assess safety of the EVOLUTION® NitrX™ system through device-related adverse event findings and/or adverse device effects during follow-up visits.
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1, 3, 5, 7, 10 years
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To assess device tolerability within subject: Adverse Events
Time Frame: 10 years post-operative
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To assess tolerability of the EVOLUTION® NitrX™ system service-related adverse event findings and/or adverse device effects during follow-up visits.
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10 years post-operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2022
Primary Completion (Estimated)
August 1, 2034
Study Completion (Estimated)
January 1, 2035
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20K001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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