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Enrolling by invitationNCT04816773Updated Mar 20, 2024

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

An observational study in Joint Diseases, Osteoarthritis and Arthritis Knee, sponsored by MicroPort Orthopedics Inc.. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.

Primary conditionOsteoarthritisRegistry: Joint DiseasesReclassifiedWhy we changed it
Registry
Joint Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Osteoarthritis
Why
  1. The study's listed conditions name Osteoarthritis, a narrower term within Joint Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by MicroPort Orthopedics Inc. (part of MicroPort Scientific Corporation) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Joint Diseases
  • Osteoarthritis
  • Arthritis Knee
  • Avascular Necrosis

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03

In context

Osteoarthritis Reclassified

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 601 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

MicroPort Orthopedics Inc. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.

First submitted after MicroPort Orthopedics Inc. became part of MicroPort Scientific Corporation.

Browse MicroPort Orthopedics Inc. studies →All MicroPort Scientific Corporation studies →

Compared within Osteoarthritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Joint Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Device: EVOLUTION® NitrX™

Interventions

  • DeviceEVOLUTION® NitrX™

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 years post-operative

  2. 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.

    Time frame: 10 years post-operative

  3. 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.

    Time frame: 10 years post-operative

Secondary outcomes

  1. Functional Scores

    To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS).

    Time frame: 10 years post-operative

  2. Functional Scores

    To assess functional scores utilizing EQ-5D-5L.

    Time frame: 10 years post-operative

  3. Functional Scores

    To assess functional scores utilizing Forgotten Joint Score (FJS).

    Time frame: 10 years post-operative

  4. Subject Satisfaction

    To assess subject satisfaction with their TKA procedure via the Satisfaction Survey.

    Time frame: 10 years post-operative

  5. Radiolucencies

    To assess the presence of radiolucencies surrounding the implanted femoral and tibial components present in each of the 17 zones.

    Time frame: 10 years post-operative

  6. 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.

    Time frame: 1, 3, 5, 7, 10 years

  7. 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.

    Time frame: 10 years post-operative

07

Study locations

2 sites
  • Sah Orthopaedic Associates
    Fremont, California 94538, United States
  • MSK Doctors, The Keep Clinic
    Grantham, Lincolnshire NG31 9AS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Aug 2034, 151 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2021
First posted
Mar 25, 2021
StartActual
Jan 27, 2022
Primary completionEst.
Aug 2034
CompletionEst.
Jan 2035
Last update
Mar 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04816773
Lead sponsor
MicroPort Orthopedics Inc.
Responsible party
Sponsor
First posted
Mar 25, 2021
Start date
Jan 27, 2022
Primary completion
Aug 2034 (estimated)
Completion
Jan 2035 (estimated)
Last update
Mar 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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