Joint DiseasesNCT06142669
EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
An observational study of Joint Diseases, run by MicroPort Orthopedics Inc. at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Joint Diseases
- What is being tested?
- EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2023to Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
- Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
- Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
- 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.
Who cannot join
- 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 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 or had documented substance abuse issues
- Has or had 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Gaetano Pini Orthopedic Institute
Milan, Piazza C. Ferrari 1 20122 Milan
Pietro Randelli, Prof, +39-335-5292-622, pietro.randelli@unimi.it
Pietro Randelli, Prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Joint Diseases
- Being tested
- EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
- Keywords
- Knee Osteoarthritis, Revision Procedure, Knee arthroplasty
- Medical subject headings
- Joint Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial InsertDevice
Primary knee arthroplasty or a revision knee that requires a revision procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years.
Percentage of knees survived with no revision or replacement at 10-year
Measured: up to 10 years
The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years.
Percentage of knees survived with no revision or replacement at 10-year
Measured: up to 10 years
The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years.
Percentage of knees survived with no revision or replacement at 10-year
Measured: up to 10 years
Secondary outcomes (7)
Functional Scores
To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS Scores) out to 10 years follow-up.
Measured: Year 1,Year 3, Year 5, Year 7, and Year 10
Functional Scores
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.
Measured: Year 1,Year 3, Year 5, Year 7, and Year 10
Functional Scores
To assess functional scores utilizing EQ-5D-5L at specified intervals out to 10 years follow-up.
Measured: Year 1,Year 3, Year 5, Year 7, and Year 10
Subject Satisfaction
To assess subject satisfaction with their TKA procedure via the Satisfaction Survey at specified intervals out to 10 years follow-up.
Measured: Year 1,Year 3, Year 5, Year 7, and Year 10
Radiolucencies
To assess the presence of radiolucencies surrounding the implanted components at specified intervals out to 10 years follow-up.
Measured: 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
To assess safety and characterize protocol defined adverse events and adverse device effects.
Measured: Year 1,Year 3, Year 5, Year 7, and Year 10
Incidence of component revision
Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up.
Measured: Year 1,Year 3, Year 5, Year 7, and Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start31 Oct 2023
- Primary completionJun 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pietro I Randelli, Prof, Principal investigator, Gaetano Pini Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142669
- Sponsor's protocol ID
- 18K001CS
- Status last verified
- Nov 2023
- First submitted
- 24 May 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
- ClinicalTrials.gov ID
- NCT06142669
- Acronym / sponsor ID
- 18K001CS
- Conditions
- Joint Diseases
- Keywords
- Knee Osteoarthritis, Revision Procedure, Knee arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Jun 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision Total Knee Arthroplasty | – | Device: EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial InsertSingle 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
- Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
- Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
- 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.
Key exclusion criteria (8 listed)
- 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 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 or had documented substance abuse issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial InsertPrimary knee arthroplasty or a revision knee that requires a revision procedure. | Device | Revision Total Knee Arthroplasty |
Primary outcome
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
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
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
7 secondary outcomes
Functional Scores
Time frame: 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
Functional Scores
Time frame: 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
Radiolucencies
Time frame: 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
Incidence of component revision
Time frame: Year 1,Year 3, Year 5, Year 7, and Year 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pietro I Randelli, Prof principal investigator
Gaetano Pini Orthopedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Diseases, run by MicroPort Orthopedics Inc. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JoAnna-Marie N Becker, BS (+1 901 290 5280, joannamarie.becker@ortho.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years. (time frame: up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.