EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

January 19, 2024 updated by: MicroPort Orthopedics Inc.

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.

The secondary objectives include:

  • Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;
  • Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;
  • To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;
  • To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;
  • To assess safety and characterize protocol defined adverse events and adverse device effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Piazza C. Ferrari 1 20122 Milan
      • Milan, Piazza C. Ferrari 1 20122 Milan, Italy
        • Recruiting
        • Gaetano Pini Orthopedic Institute
        • Contact:
        • Principal Investigator:
          • Pietro Randelli, Prof

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Multicenter, prospective follow-up study of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of the study index surgery.

Description

Inclusion Criteria:

  1. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)
  2. Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
  3. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
  4. Willing to voluntarily sign the informed consent form
  5. 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.

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 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
  4. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
  5. Has or had documented substance abuse issues
  6. Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  7. Currently incarcerated or has impending incarceration
  8. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Revision Total Knee Arthroplasty
Single study group with either newly or previously implanted subjects with the EVOLUTION® Revision Tibia and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Insert.
Device: EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
Primary knee arthroplasty or a revision knee that requires a revision procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years.
Time Frame: up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
up to 10 years
The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years.
Time Frame: up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
up to 10 years
The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years.
Time Frame: up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
up to 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Scores
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS Scores) out to 10 years follow-up.
Year 1,Year 3, Year 5, Year 7, and Year 10
Functional Scores
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
To assess subject satisfaction with their Total Knee Arthroplasty (TKA) procedure utilizing the Forgotten Joint Score (FJS) at specified intervals out to 10 years follow-up.
Year 1,Year 3, Year 5, Year 7, and Year 10
Functional Scores
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
To assess functional scores utilizing EQ-5D-5L at specified intervals out to 10 years follow-up.
Year 1,Year 3, Year 5, Year 7, and Year 10
Subject Satisfaction
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
To assess subject satisfaction with their TKA procedure via the Satisfaction Survey at specified intervals out to 10 years follow-up.
Year 1,Year 3, Year 5, Year 7, and Year 10
Radiolucencies
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
To assess the presence of radiolucencies surrounding the implanted components at specified intervals out to 10 years follow-up.
Year 1,Year 3, Year 5, Year 7, and Year 10
To assess subject safety: Adverse Events o Adverse Events related to study device or the index surgical procedure
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
To assess safety and characterize protocol defined adverse events and adverse device effects.
Year 1,Year 3, Year 5, Year 7, and Year 10
Incidence of component revision
Time Frame: Year 1,Year 3, Year 5, Year 7, and Year 10
Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up.
Year 1,Year 3, Year 5, Year 7, and Year 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort Orthopedics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pietro I Randelli, Prof, Gaetano Pini Orthopedic Institute

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18K001CS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings